Preliminary Findings of Low-Cost Interventions to Increase Physical Activity in Adults at Risk for a Diabetic Foot Ulcer
Ryan T. Crews, MS1, Kristin L. Schneider, PhD2, Sungsoon Hwang, PhD3, Elizabeth Moxley, PhD, RN, BS4, Vasanth Subramanian, MS1, Laura Aylward, MS2, Frank E. DiLiberto, PT, PhD5, and Sai V. Yalla, PhD1
1Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA
2Department of Psychology at Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA
3Department of Geography at DePaul University, Chicago, IL, USA
4School of Nursing at DePaul University, Chicago, IL, USA
5Department of Physical Therapy at Rosalind Franklin University, North Chicago, IL, USA
Corresponding Author:
Ryan T. Crews, Dr William M. Scholl College of Podiatric Medicine’s Center for Lower Extremity Ambulatory Research (CLEAR) at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Rd, North Chicago, IL 60064, USA.
Email: ryan.crews@rosalindfranklin.edu
Abstract
Purpose: Physical activity (PA) is not contraindicated for those at risk for diabetic foot ulcers (DFU)1,2 and increasing PA may actually reduce DFU risk.3,4 However, supervised interventions are typically not reimbursable and can be burdensome. The present study tests the feasibility of low-cost PA strategies for adults at risk for DFUs.
Methods: Five moderate/high risk patients have completed the study. DFU preventative measures of plantar pressure customized insoles, diabetic shoes, and an infrared foot thermometer were provided to participants. Participants completed four 1-hour supervised PA sessions including training in safely increasing PA and strategies for increasing PA over a 2-week period. Then participants completed 8 weeks of low-cost behavioral and technological (commercial activity monitor- Fitbit, online social network & text messaging) PA interventions. Baseline and end of study location-specific PA was measured for 1 week by syncing a GPS monitor and tri-axial accelerometer (Figure 1). End of study key informant interviews were conducted.
Figure 1.
Minutes spent on weight bearing activities (WBA) at out-of-home stops by subject 01 preintervention.
Results: Three females and 2 males aged 63.4 year (range: 56-74 year) with a BMI of 36.8 (range: 30.4-46.4) participated. Four of the subjects completed all 4 supervised PA sessions and the fifth completed 2 sessions. Subjects met their weekly step count goals 66.7% of the weeks they were given (range: 33.3-100%). Baseline and end of study PA metrics are presented in Table 1. Subjects reduced their baseline Hba1c of 7.80 (range: 7.0-8.4) to 7.65 (range: 6.7-8.8) at end of study. Initial results of key-informant interviews suggest that the use of in-person physical activity sessions, the text messages, and the commercial activity monitor were the most preferred aspects of the intervention. Participants rarely accessed the online social network due to limitations in its functionality.
Table 1.
Physical Activity Measures Pre- and Post-intervention.
| Baseline mean | Baseline range | End of study mean | End of study range | |
|---|---|---|---|---|
| Walking per day (hr) | 0.93 | (0.76-1.2) | 1.2 | (0.69-1.5) |
| Standing per day (hr) | 3.6 | (3.2-4.2) | 4.0 | (3.56-5.9) |
| Steps per walking bout | 20.6 | (17.6-30.2) | 24.6 | (16.6-44.1) |
| Walking cadence (steps/min) | 77.3 | (73.2-81.8) | 79.1 | (73.5-85.2) |
| Sit to stand transitions per day | 791 | (634-1072) | 927 | (624-1271) |
| Sitting per day (hr) | 6.5 | (3.5-10.4) | 7.2 | (3.1-10.6) |
| Lying per day (hr) | 13.5 | (10.0-16.5) | 12.1 | (8.8-16.5) |
| 6min walk test (m) | 411 | (379-466) | 433 | (385-477) |
Physical activity was monitored for 7 days at baseline and 7 days at end of study.
Discussion: These preliminary findings suggest low-cost behavioral and technological interventions may potentially be able to improve PA profiles of at-risk individuals. In addition to benefiting glycemic control, improvements in PA may also reduce DFU risk as previous studies of at-risk patients have associated low average PA levels with higher DFU risk.3,4
References
1. Colberg SR, Sigal RJ, Fernhall B, et al. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010;33(12):e147-e167.
2. Mendes R, Sousa N, Reis VM, et al. Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Postgrad Med J. 2013;89(1058):715-721.
3. Armstrong DG, Lavery LA, Holtz-Neiderer K, et al. Variability in activity may precede diabetic foot ulceration. Diabetes Care. 2004;27(8):1980-1984.
4. Lemaster JW, Reiber GE, Smith DG, et al. Daily weight-bearing activity does not increase the risk of diabetic foot ulcers. Med Sci Sports Exerc. 2003;35(7):1093-1099.
Healing Diabetic Ulcers With a New Topical Antibiotic Ointment
Christopher Otiko, DPM
Corresponding Author:
Christopher Otiko, DPM, 6650 Reseda Blvd, Suite 101A, Reseda, CA 91335, USA.
Email: drotiko@yahoo.com
Abstract
Background: Diabetes affects almost a half a billion people globally with 23 million affected in the United States. With about 83 million affected with condition designated as prediabetes. Of those with diabetes, 50% will develop peripheral neuropathy and/or diabetic ulcers. Of the 23 million people affected with diabetes, 25% will develop diabetic ulcers many will require expensive therapy or invasive surgical amputations.
Objective: The goal of this study was to evaluate the efficacy and safety of an FDA-registered OTC tetracycline hydrochloride–based topical solution containing a patent-pending dual carrier advanced transdermal delivery system. The medication is simply a topically applied antibiotic ointment designed for the treatment of diabetic foot ulceration.
Research Design and Methods: Clinical investigation (CI) documenting the treatment effectiveness was estimated by enrolling consecutive patients in a multicenter outpatient clinic setting.
Results: The topical antibiotic was more effective than standard care, including IV antibiotics. The effect was greatest in those with the most severe wounds, that is, large wounds that affect deeper anatomical structures. These patients were last resort patients that had failed all previous care and were headed to an amputation. In some cases even an amputation wasn’t feasible because of the patient’s cardiac status.
Conclusions: The topical antibiotic is more than 96% effective in healing diabetic foot ulcers within 4 weeks. This effect is more pronounced in more severe wound, and the effect is the same whether the wound is infected or not.
Diabetic Foot in Algeria
Nadia Boudjenah1
1Medical Center Boudjenah, Bouzaréah, Algiers, Algeria
Corresponding Author:
Nadia Boudjenah, Medical Center Boudjenah, Bouzaréah, Algiers 16000, Algeria.
Email: drboudjenah@yahoo.fr
Abstract
Purpose: Our experience of diabetic foot in Algeria
Two particularities: severity of lesions: specialized center?
absence of vascular surgery at our level
Two strong points: therapeutic: Carbomedtherapy
economic: outpatient practice
Our results: less than 0,5% of major amputations
Method: Tests: Blood, bacteriological, Arterial and venous echo-doppler, Electroneuromyogram
Treatments: Targeted antibiotics and/or anticoagulants
Localized care:
Foot bath: water with hydrogen peroxide
Rehydration: locally made cream
Mycoses care
Carbomedtherapy: transcutaneous injections of carbon dioxide on the limbs, on, and around the wound, and considering there are no contraindications, as outpatients: by-monthly or monthly sessions.
(French technique, 84 years old)¹, easy to use, low cost. Its action is explained by the BOHR effect.
Quicker healing and improved neuropathy because of better oxygenation of all tissues (Les neuropathies périphériques chez les diabétiques)².
Repetition of the sessions leads to a neo-angiogenesis, perpetrating capillary revascularization.
Results: More than 22.000 patients have been treated at our medical center during the last 8 years’ time.
For the year 2016, we treated 7824 new patients.
29% without wounds:
symptomatic arteriopathy and/or neuropathy improvement of the walking perimeter, reducing pain and tingling, improving the quality of life.
No major amputations if simple infectious lesion.
240 toes resections; emptying and drainage allowed us to treat them, combined with a cutaneous graft to reduce the healing time
10 osteosynthesis by fixations for osteitis
5 external fixators of osteoarthritis of the ankle.
Vascular lesions: 42 amputations on first visit
5 after surgery
12 aggravation of lesions, with the nonavailability of vascular surgery and existence of contraindications to carbomedtherapy.
Less than 0.5% of major amputation.
12 deaths: because of advanced age, poor general condition, which may be, an indication of amputation, in 2017!
320 CHARCOT foot enumerated: we just start in this complex surgery.
Conclusions: The safety and efficacy of CARBOMEDTHERAPY make this very simple technique, an appreciable tool, especially since it performed on an outpatient basis, thus reducing the cost of the treatment, and allowing a better comfort for our patients, allowing us to reduce our amputation rate to 0.5%.
References
1. Fabry R, Monnet P, Schmidt J, et al. Clinical and microcirculatory effects of transcutaneous of CO2 therapy in intermittent claudication. Vasa. 2009;38:213-224.
2. Hartemann A, Lozeron P. Les neuropathies périphériques chez les diabétiques. MCED. 2015;74:70-73.
Evaluating Novel Footwear for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology
David Armstrong, DPM, MD, PhD1, Bijan Najafi, BSc, MSc, PhD2, Lawrence Lavery, DPM, MPH3, Paul Canavan, PhD4, and Mark Roser4
1University of Arizona, Tucson, AZ
2Baylor College of Medicine, Houston, TX
3University of Texas, Dallas, TX
4Results Group, Hebron, CT
Corresponding Author:
Mark C. Roser, Results Group, LLC, 1 Technology Dr, Tolland, CT 06084.
Email: Mark.Roser@ResultsGroupLLC.org
Purpose: Ulceration of the diabetic foot occurs frequently in the forefoot region, through abnormal forefoot pressure over time by increased loading and shear in individuals with high BMI and high peak pressures during walking.1 The novel footwear off-loads the forefoot to help to minimize pressure and peak pressure.
Methods: The novel footwear, with a patented exoskeleton and an adjustable Achilles exotendon spring, is in process of being evaluated with 10 participants. Using subjects as their own controls, F-Scan (TekScan, Boston, MA) plantar pressure measuring insoles were utilized to measure the pressure within the footwear during a 6-meter walk at self-selected speed. A computer derived average of four strides were utilized, enabling analysis of pressure along the footbed during the 6-meter walking gait test.
Figure 1.
F-Scan plantar pressure image comparing no spring condition on left, and spring engaged condition on right. Source: Kairavi Vaishnav, University of Arizona College of Medicine.
Results: The results of the proof-of-concept testing has demonstrated that engaging the exotendon spring force can reduce forefoot plantar pressure by >22%, in one example from 518 KPa to less than 412 KPa. With no spring engaged, peak pressure was identified in the forefoot region. With a spring engaged, peak pressure was identified in the hindfoot region. Thus indicating that the Center of Pressure and the location of Peak Plantar Pressure had shifted away from areas of highest risk for foot ulceration. Time to Reach Peak Pressure (elapsed time) was reduced 1%. From 0.625 seconds to 0.618 seconds, indicating one example of a consistent, if not slight increase in walking speed with springs engaged. Loading Rate (Pressure Time Interval—the speed at which pressure increases) was reduced >20% in this subject. From 839.3 KPa/S to 666.1 KPa/S.
Conclusions: The interim results demonstrate that that this novel footwear may potentially be utilized to off-load forefoot pressure, and thereby also reduce shear, and help mitigate the factors associated with diabetic foot ulcer. Further testing will be conducted to continue gaining deeper inside into dynamic walking and functional assessments.
Reference
1. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293(2):217-228.
Evaluation of the Effectiveness and Cost-Effectiveness of Lightweight Fiberglass Heel Casts in the Management of Heel Ulcers in Diabetes: An Observer-Blinded Randomized Controlled Trial
Frances Game, FRCP1,2, William Jeffcoate, MRCP2, Vivienne Turtle-Savage2, Alison Musgrove2, Patricia Price, PhD3, Wei Tan4, Lucy Bradshaw, MSc4, Alan Montgomery, PhD4, Deborah Fitzsimmons, PhD5, Angela Farr, BSc5, Tom Winfield5, and Ceri Phillips, PhD5
1Derby Hospitals NHS Foundation Trust, Derby
2Foot Ulcer Trials Unit, Nottingham University Hospitals Trust, Nottingham, UK
3Cardiff University
4Clinical Trials Unit, University of Nottingham
5Swansea University, UK
Corresponding Author:
William Jeffcoate, MRCP, Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, Nottingham NG5 1PB, UK.
Email: william.jeffcoate@gmail.com
Purpose: An uncontrolled pilot study suggested in 2008 that lightweight fiberglass casts might result in a marked acceleration of healing of heel ulcers in diabetes.1 The aim of this study was to undertake a formal evaluation of this intervention.2 The study was funded by the UK NIHR Health Technology Assessment Programme.
Methods: Participants from 35 specialist services were randomized 1:1 to either usual good care (control) or usual good care plus heel cast (intervention). The study was powered to detect a difference in healing of 40% (controls) versus 55% by 24 weeks. Soft tissue infection, peripheral artery disease and impaired renal function were not exclusion criteria. Participants were reviewed fortnightly when the ulcer was cleaned and re-dressed. Other dressing changes were made by their usual carer. Secondary outcomes included time to healing, secondary infection, pain, and minor or major amputation. Health economic analysis was undertaken to assess the incremental cost per QALY.
Results: A total of 509 participants (68% male; mean age 67.5 ± 12.4 years) were recruited. Median ulcer area was 275 mm2 and ulcer duration at baseline was at least 2 weeks. In all, 256 and 253 participants were randomized to the intervention and control groups, respectively. When analyzed by intention to treat, 94 (44%) of the intervention group healed with 24 weeks of follow-up, compared with 80 (37%) in the control group (OR 1.42 [0.95, 2.14], P = .088). There was no difference between groups in any other outcome measure or in adverse events. The costs in the two groups were not statistically different.
Conclusions: The study was conducted to a high standard. It was not possible to demonstrate clear benefit from the use of fiberglass heel casts in the management of heel ulcers in diabetes. Level of evidence is 1b.
References
1. Sharpe A. An introduction to the guideline for the provision of heel casts for the treatment of heel ulcers. Wounds UK; 2016. Available at: http://www.wounds-uk.com/pdf/content_11764.pdf.
2. Jeffcoate W, Game F, Price P, Phillips C, Turtle-Savage V. Evaluation of lightweight heel casts in the management of ulcers of the heel I diabetes: study protocol for a randomised controlled trial. Trials. 2014;15:462. doi:10.1186/1745-6215-15-462.
Safety and Efficacy of Plasmid DNA Expressing Two Isoforms of Hepatocyte Growth Factor in Patients With Critical Limb Ischemia: Evaluation of Patients With Nonhealing Ulcers
Melina R. Kibbe, MD1, Alan T. Hirsch, MD2, Farrell O. Mendelsohn, MD3, Mark G. Davies, MD, PhD4, Hau Pham, MD5, Jorge Saucedo, MD6, William Marston, MD7, Wook-Bum Pyun, MD, PhD8, Seung-Kee Min, MD, PhD9, Brian G. Peterson, MD10, Anthony Comerota, MD11, Donghoon Choi, MD, PhD12, Jeffrey Ballard, MD13, Rebecca A. Bartow, PhD14, Douglas W. Losordo, MD1, Warren Sherman, MD15, Vicki Driver, DPM5, and Emerson C. Perin, MD, PhD14
1Northwestern University Feinberg School of Medicine, Chicago, IL, USA
2University of Minnesota Medical School, Minneapolis, MN, USA
3Cardiology P.C. Research, Birmingham, AL, USA
4The Methodist Hospital, Houston, TX, USA
5Boston University School of Medicine, Boston, MA, USA
6University of Oklahoma HSC, Oklahoma City, OK, USA
7University of North Carolina School of Medicine, Chapel Hill, NC, USA
8Ewha Womans University Medical Center, YangCheon-Ku, Seoul, Korea
9Seoul National University Hospital, Jongno-gu, Seoul
10Saint Louis University Hospital, St. Louis, MO, USA
11Jobst Vascular, Toledo, OH, USA
12Yonsei University Severance Cardiovascular Hospital, Seodaemun-gu, Seoul, Korea
13Vascular & Interventional Specialists of Orange County, Orange, CA, USA
14Texas Heart Institute, Houston, TX, USA
15Columbia University Medical Center, New York, NY, USA
Corresponding Author:
Emerson C. Perin, DPM, MD, PhD, Texas Heart Institute, MC 2-255, 6720 Bertner Ave, Houston, TX 77030.
Email: eperin@texasheart.org
Purpose: Previously, we conducted a clinical trial to assess the safety and potential efficacy of intramuscular injections of a novel plasmid DNA expressing 2 isoforms of hepatocyte growth factor (HGF-P) in patients with critical limb ischemia (CLI).1 Here, we more closely explore its effects on nonhealing foot ulcers.
Methods: In a phase 2, double-blind, multicenter trial, we enrolled 52 no-option CLI patients (Rutherford class, 4-5), of which 30 had diabetes. Participants were randomly assigned 2:2:1 to low-dose HGF-P (8 mg; n = 21), high-dose HGF-P (16 mg; n = 20), or placebo (saline; n = 11) groups. Intramuscular injections (n = 16) were administered in the affected calf on days 0, 14, 28, and 42. Adverse events, ankle and toe-brachial indices (ABI, TBI), visual analog score (VAS) for pain, transcutaneous oxygen pressure (TcPO2), and ulcer healing rates were assessed at various time points over the 12-month follow-up period.
Table 1.
Change in Efficacy Parameters During the 12-Month Follow-Up Period.
| Group | Ulcers closed (n)a | Ulcers partially closed2 (n)b | Increase in TcPO2 (n)c |
|---|---|---|---|
| Placebo | 11% | 11% | 29% |
| (1/9) | (1/9) | (2/7) | |
| Low dose, 8 mg HGF plasmid | 52% | 70%*** | 77% |
| (14/27) | (19/27) | (10/13) | |
| High dose, 16 mg HGF plasmid | 62%* | 69%** | 73%† |
| (8/13) | (9/13) | (11/15) |
Number of ulcers.
Reduction of ulcer area >50%.
Number of patients.
P = .031, versus placebo. **P = .011, versus placebo. ***P = .005, versus placebo. †P < .05, versus placebo.
Results: Adverse events and serious adverse events (SAE) were similar among the groups; one SAE (peroneal deep vein thrombosis) was possibly related to the study drug. The high-dose group showed significantly better ulcer closure than did the placebo group, with 62% of ulcers closed at 12 months compared with 11% in the placebo group (Table 1). TcPO2 also improved the most in the high-dose group (Table 1). Furthermore, VAS results indicated that 70% of those in the high-dose group experienced pain reduction 9 months after injections. The mean change in ABI from baseline to 9 months was higher in the high-dose group (0.095) than in the low-dose (0.052) or placebo (0.004) groups (P = NS).
Conclusions: HGF-P injections are safe and well-tolerated in CLI patients and may improve the microvascular and macrovascular environment of nonhealing ulcers.1,2 Based on these results, a phase 3 study is planned to assess the effects of HGF-P (16mg) on wound closure in diabetic patients with peripheral artery disease and nonhealing ulcers.
References
1. Kibbe MR, Hirsch AT, Mendelsohn FO, et al. Safety and efficacy of plasmid DNA expressing two isoforms of hepatocyte growth factor in patients with critical limb ischemia. Gene Ther. 2016;23(4):399.
2. Powell RJ, Goodney P, Mendelsohn FO, Moen EK, Annex BH, HGF-0205 Trial Investigators. Safety and efficacy of patient specific intramuscular injection of HGF plasmid gene therapy on limb perfusion and wound healing in patients with ischemic lower extremity ulceration: results of the HGF-0205 trial. J Vasc Surg. 2010;52(6):1525-1530.
The National Diabetic Foot Ulcer Audit of England and Wales 2014-2016: Shorter Time to Expert Assessment Is Associated With Significantly Improved Outcome
William Jeffcoate, MB1, Gerry Rayman, MD2, Arthur Yelland, MA3, Claire Meace, BA3, Tom Latham3, Julie Michalowski, MSc3, and Bob Young, MD4
1Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, City Hospital Campus, Nottingham, UK
2Ipswich Hospitals NHS Trust, Ipswich, UK
3NHS Digital, Leeds, UK
4Salford Royal NHS Foundation Trust, Salford, UK
Corresponding Author:
William Jeffcoate, MB, Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, Nottingham NG5 1PB, UK.
Email: william.jeffcoate@gmail.com
Purpose: The purpose is to report the 2014-2016 results of the ongoing National Diabetic Footcare Audit (NDFA) of England and Wales,1 which is designed to explore aspects of the management of diabetic foot ulcers in relation to the tenfold geographical variation in incidence of major amputation in the UK.2
Methods: All those providing specialist services for the care of diabetic foot disease are asked to register each new case of foot ulceration referred to them and to collect data on (1) the time elapsed from first presentation to a health care professional and the first expert assessment, (2) the severity of the ulcer, and (3) the clinical outcome. The primary patient-centered outcome measure is the percentage alive and ulcer-free at 12 and 24 weeks.
Results: Time to first expert assessment of 13,034 new ulcers presenting July 2014-March 2016 varied from <2 days to ≥2 months; at presentation those waiting ≥2 months were more likely to be severe (using the SINBAD score), 57.5 versus 49.7%, P < 0.05. Those with severe ulcers at baseline were less likely to be alive and ulcer-free at both 12 (less severe 60.3% vs severe 34.7%) and 24 weeks (74.5% vs 56.0%). Moreover, the numbers alive and ulcer-free at both times was significantly worse when the time to first expert assessment was greater than 2 weeks. There was wide geographical variation in outcome.
Conclusions: These early results provide strong support for the current recommendation that all newly occurring ulcers should receive early referral for expert assessment. Case-mix adjusted comparison of outcome between different health care services will be available from cross linkage with Hospital Episode Statistics and the parent National Diabetes Audit.
References
1. Jeffcoate W, Young B. National diabetic foot audit of England and Wales. Diabet Med. 2016;33:1464-1465.
2. Holman N, Young RJ, Jeffcoate WJ. Variation in the recorded incidence of amputation of the lower limb in diabetes. Diabetologia. 2012;55:1919-1925.
Utilizing Dehydrated Amniotic Membrane Allografts (DAMA) in Combination With Total Contact Casting for Diabetic Foot Ulcers
Emily Greenstein, APRN, CNP, CWON1
1Sanford Health, Fargo, ND, USA
Corresponding Author:
Emily Greenstein, APRN, CNP, CWON, Sanford Health, Fargo, ND, USA.
Email: Emily.Greenstein@sanfordhealth.org
Purpose: Chronic wounds have decreased levels of growth factors, and amniotic membranes are known to contain collagens and various growth factors to aide in healing.1-3 The purpose of this case series is to evaluate the effectiveness of using dehydrated amniotic membrane allograft with a roll-on TCC on chronic diabetic foot ulcers (DFU).
Methods: This is a retrospective case series (n = 4) describing the successful outpatient management of challenging diabetic foot ulcers using dehydrated amniotic membrane allograft (DAMA) in conjunction TCC as a standard of care (SOC).
Results: Case 1 is a 45-year old male with DFU to the right great toe. Wound was present for 6 months. Four serial applications of DAMA in conjunction with TCC showed complete wound resolution in 23 days. Case 2 is a 63-year old male with DFU to the left great toe. Wound was present for 14 months. Three serial applications of DAMA in conjunction with TCC showed complete wound resolution in 20 days. Case 3 is a 57-year old female with DFU to the right great toe. Wound was present for 8 months. Three serial applications of DAMA in conjunction with TCC showed complete wound resolution in 20 days. Case 4 is a 61-year old male with DFU to the plantar aspect of the left forefoot. Wound was present for approximately 4 years. Three serial applications of DAMA in conjunction with TCC showed complete wound resolution in 21 days.
Conclusion: This case series demonstrates the benefits of DAMA in conjunction with TCC as a SOC for chronic nonhealing DFU that have not previously responded to traditional measure of wound care. Average applications of 3.25 and complete re-epithelization in 21 days.
References
1. Bryant RA, Nix DP. Acute and Chronic Wounds: Current Management Concepts. 4th ed. St. Louis, MO: Mosby Elsevier; 2012.
2. Herbst B. Using aminoexcel amniotic tissue and the TCC-EZ healing chamber to heal a diabetic foot ulcer. Ostomy Wound Management. 2015;61(11):10-12.
3. Serena T, Zelen C. Amniotic membrane: can it facilitate healing? Podiatry Today. 2015;28(4).
Novel Ancillary for Diabetic Foot Management With Transforming Powder Dressing
Nune Soghomonyan, MD1 and Hamazasp Khachatryan2
1Diabetic Foot Department, MC Kanaker-Zeytun, Yerevan, Armenia
2Yerevan State Medical University, Armenian Association of Diabetic Foot, Yerevan, Armenia
Corresponding Author:
Nune Soghomonyan, MD.
Email: nunesoghomonian@yahoo.com
Purpose: Comparison of outcomes of diabetic wound treatment between standard and standard plus transforming powder dressing groups of diabetic foot patients.
Methods: Three patients with diabetic foot postoperative wounds with secondary wound infection are chosen for the follow up in each group. In both groups with and without transforming powder dressing management one patient was after transmetatarsal resection for distal severe foot infection, one after toe amputation with osteomyelitis, and one with neuropathic ulcer.
Results: Patients treated with transforming powder dressings management parallel to standard wound management including local antiseptics, negative pressure treatment, debridements, as well as ischemia correction, normoglycemia, sepsis management, and orthopedic shoe wearing, revealed better life quality with less painful follow up and earlier healing periods. Transmetatarsal amputation wound healed after three months instead of five months, toe amputation wound closed in one month in contrast to three months, and neuropathic ulcer was epithelized in three months in contrast to six months.
Conclusions: Transforming powder dressings obviously improve outcomes of diabetic foot wound healing effectively completing standard therapies from the point of view of shortening duration of treatment and improving quality of life.
Exploration of Serial Changes in the Microbiome in Heel Ulcers Complicating Diabetes
William Jeffcoate, MB1, Frances Game, FRCP2, Jim Turton, PhD3, Tim Sloan, FRCPath3, Vicki M. Fleming, PhD3, and Mat Diggle, FRCPath3
1Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, Nottingham, UK
2Department of Diabetes and Endocrinology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK
3Department of Microbiology, Nottingham University Hospitals Trust, Nottingham, UK
Corresponding Author:
William Jeffcoate, MB, Foot Ulcer Trials Unit, Department of Diabetes and Endocrinology, Nottingham University Hospitals Trust, Nottingham NG5 1PB, UK.
Email: william.jeffcoate@gmail.com
Purpose: The purpose was to explore serial changes in the microbiome by examining surface swabs taken each two weeks during the course of a trial of an off-loading device used for ulcers of the heel.
Methods: From a total 509 participants in an independent trial, 35 were selected casually and consented to have surface swabs taken for study of the microbiome each two weeks until healing or 24 weeks. Ulcer samples were taken with flocked swabs using Levine’s technique before freezing at −80oC. Following DNA extraction, amplicons of the V4 region of the 16S rRNA gene were sequenced on the Illumina MiSeq platform and assigned to taxonomy at genus level with USEARCH and the RDP 16S database. Unsupervised clustering with principal coordinates analysis was used to identify taxa contributing to the greatest variation between samples.
Results: Preliminary analysis of the bacterial community in samples from 20 participants revealed differences in the patterns of organisms isolated from different individuals, however the community composition was relatively stable within any one ulcer over time. Predominant taxa were similar to those observed in previous studies1 including Corynebacteria, Staphylococci, Enterobacteriaceae, Pseudomonas, and anaerobes. While greater temporal stability was observed than that reported by Loesche et al,2 dramatic shifts in community composition were sometimes seen in some individuals and some of these may have been associated with episodes of infection and their treatment with antibiotics.
Conclusions: Diabetic foot ulcers appear to possess a “signature” blend of microbes although temporal sampling enables the detection of unexpected instability in composition. Refinement of this technique may allow identification of changes which predict the later emergence of clinical infection or, alternatively, of changes which may herald impending wound closure.
References
1. Dowd SE, Sun Y, Secor PR, et al. Survey of bacterial diversity in chronic wounds using pyrosequencing, DGGE, and full ribosome shotgun sequencing. BMC Microbiol. 2008;8:43.
2. Loesche M, Gardner SE, Kalan L, et al. Temporal stability in chronic wound microbiota is associated with poor healing. J Invest Dermatol. 2017;137:237-244.
Audit of Major Amputations in Bedford General Hospital
Tapan A. Mehta, MBBS, MD, FRCS1
1Bedfordshire-Milton Keynes (BMK) Vascular Unit, Bedford Hospital, Bedford, UK
Corresponding Author:
Tapan A. Mehta, MBBS, MD, FRCS, Bedfordshire-Milton Keynes (BMK) Vascular Unit, Bedford Hospital, Kempston Rd, Bedford MK42 9DJ, UK.
Email: tapan.mehta@bedfordhospital.nhs.uk
Purpose: The purpose was to study patient demographics, risk factors, and outcomes in patients undergoing major lower limb amputations—below knee (BKA) or above knee (AKA)—in a District General Hospital in the United Kingdom.
Methods: This study is a retrospective audit of patients undergoing major amputations BKA or AKA in a 7-year period beginning March 2015. Patient demographics, risk factors notably diabetes and smoking status, and outcomes including length of stay, complications, and mortality were studied to identify factors that could be modified to improve results.
Results: A total of 156 patients (121 men, average age 69 years) underwent a major amputation (53% had an above knee amputation) during the study period. In all, 85 patients (54.5%) were diabetic and 74 patients (47.4%) were current or ex-smokers. Of the patients, 116 (74.4%) were American Association of Anaesthesiologists (ASA) grade 3 or 4. The mean total length of stay was 27.5 days and the mean postoperative length of stay was 18.8 days. The average 30 day or in-hospital mortality was 10.25%. All patients were referred to a dedicated limb fitting and rehabilitation unit after discharge. Diabetic smokers were significantly younger and had a higher proportion of ASA 3 and 4 patients than nondiabetic nonsmokers. They were also more likely to develop a major complication. However, the likelihood of needing an AKA, total, and postoperative length of stay in hospital and mortality were no different in this subgroup of patients.
Conclusions: Smoking cessation in diabetic patients undergoing major amputation may improve outcomes in terms of complications, but does not impact on mortality and length of hospital stay.
Diabetes-Related Foot Care Interventions for Preventing Diabetic Foot Ulceration: A Systematic Review of Literature
David Oni, MSN, BSN, RN1
1Washington State University, College of Nursing, Spokane, WA, USA
Corresponding Author:
David Oni, MSN, BSN, RN 600 Riverpoint Blvd, Washington State University, College of Nursing, Spokane, WA, USA.
Email: david.oni@wsu.edu
Purposes: The purpose of this systematic literature review was to assess the effectiveness of foot care intervention on improving foot care practices and preventing foot ulcers in patients with diabetes mellitus, to establish gaps in research and further inform the future studies.
Background: Foot care practices prevent foot complications and reduces incidence of DFUs and reulceration in patients with diabetes. Moreover, foot care practices are strongly recommended as part of preventive strategies for diabetes foot complications. However, preventing diabetic foot ulceration, and reulceration, in diabetes patients remains very challenging because limited interventions have been successful. There is no robust evidence to support the effectiveness of foot care interventions in preventing DFUs and reulcerations in diabetes patients with and without foot ulceration. Reviewing current interventional studies on foot care practices is imperative to establish gaps in literature and inform future research studies. The overall quality of studies on interventions to prevent a foot ulcer in at-risk patients with diabetes should further improve, so that stronger recommendations can be provided for future clinical practice.
Searching Methods: The PubMed, CINAHL, PsycINFO, and Cochrane Reviews databases were searched. Only randomized controlled trials and systematic reviews studies on foot care practices interventions in diabetes patients with or without foot ulcers were included. Findings were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
Selection Criteria: Prospective randomized controlled trials (RCTs) and systematic reviews that evaluated foot care interventions for preventing foot ulcers in people with diabetes mellitus were examined.
Data Collection and Analysis: The author undertook data extraction and assessment of risk of bias. Primary outcomes were self-foot care practices, foot ulceration or ulcer recurrence, and amputation.
Results: Of the 10 systematic reviews and 2 RCTs included, the effect of interventions on primary outcomes were reported in all studies. Several studies showed significant improvement in patients’ diabetic foot care practices following foot care practices interventions. However, interventions have only a short-term effect on foot care practices and little benefit in preventing diabetic foot ulcers. Only one RCT study showed significant reductions in the incidence of diabetic foot ulcers and amputation. Most studies were precluded with methodological flaws raging from heterogeneous samples, under-powered samples, and failure to address methods of randomizations, concealment, blinding and failure to reports characteristics of control and intervention groups.
Implication: Promoting self-foot care practices, and preventing diabetic foot ulceration in diabetes still remains very challenging because few interventions have been successful. There is no robust evidence to support the effectiveness of current interventions in preventing DFUs and reulcerations in diabetes patients with or without foot ulcers. There is a paucity of high-quality evidence, and an urgent need for a well-designed randomized control trials to provide robust evidence on clinical and educational interventions to prevent DFUs, reulcerations, and amputations and promote long-term foot care practices in patients with diabetes mellitus.
The NHS’s Game Changer for DFUs: Ways to Invest for a Novel TCC to Save Diabetic Feet
Graham Bowen, FCPM, BSc (Hons), HCPC1 and Mayank Patel, BM MRCP DM2
1Solent NHS Trust, Hampshire, UK
2University Hospital Southampton NHS Foundation Trust, Hampshire, Mayank, UK
Corresponding Author:
Graham Bowen, FCPM, BSc (Hons), HCPC, Solent NHS Trust, Hampshire, UK.
Email: Graham.Bowen@solent.nhs.uk
Purpose: Within the UK, NICE NG 191 states offer nonremovable casting to offload plantar neuropathic, nonischemic, uninfected forefoot and midfoot diabetic ulcers and offer an alternative offloading device until casting can be provided. Total contact casting (TCC) is widely underutilized within the NHS and has poor patient adherence rates.2
Methods: With Solent NHS Trust, there has been historically restricted capacity for DFUs to be offered TCC in secondary care, as the “gold standard” treatment and funding was sought for podiatry to provide 50% of all DFUs within the community, a novel TCC casting device that can help to offset some of the challenges of TCC, as it is simpler to apply and found to be more comfortable than traditional TCC. This was successfully secured via a CQUIN and a business case for 4 local CCGS. The novel TCC is now embedded in podiatry practice within Solent NHS Trust.
Results: Securing investment for a NHS provider to fund the use of a novel TCC, which has significantly increases clinical capacity, resulting in a major impact on patient outcomes that includes resolution of both chronic and acute DFUs and the prevention of amputations. 2016/17 funding for 274 patients with DFUs to have a novel TCC and to date, 108 patients have had this with 86% of these healing within 8 weeks. Significant results include patients with chronic bilateral DFUs of 12 months duration which have healed and patients waiting for kidney transplants and joint replacements, who were unable to have these with active DFUs. These patients subsequently healed with this novel TCC allowing their planned procedures to be undertaken which have changed their lives. Podiatry team trained, the cohort of DFUs within Solent NHS Podiatry service now have the access they need to the “gold standard” of treatment.
Conclusion: This novel TCC is now incorporated into the Diabetic Foot pathway providing the nonremovable casting solution as indicated by NICE NG 19;1 it is cost effective, heals DFUs quicker, prevents amputations and should be provided to all suitable patients with DFUs as the treatment of choice within the NHS.
References
1. NICE NG 19. Diabetic foot problems: prevention and management 2015. Available at: https://www.nice.org.uk/guidance/ng19.
2. Wounds International. International best practice guidelines: wound management in diabetic foot ulcers. 2013. Available at:www.woundsinternational.com.
Combined Ultrasound and Electric Field Stimulation and Diabetic Foot Ulcers: The Israeli and Italian Experience
Jonathan Rosenblum, DPM1, Ram Avrahami, MD2, Fabrizia Toscanella, MD3, and Nachum Greenberg, MD4
1Diabetic Foot Service, Shaarei Zedek Medical Center, Jerusalem, Israel
2Department of Vascular Surgery, Beilinson Medical Center, Petach Tivka, Israel
3Department of Diabetology, Villa Tiberia, Rome, Italy
4Diabetic Foot Service, Shaarei Zedek Medical Center; Jerusalem, Israel
Corresponding Author:
Jonathan Rosenblum, DPM, Shimon St. 17, Bet Shemesh, Israel 99543.
Email: diabfootman@gmail.com
Introduction: Both ultrasound and electric stimulation have been used with varied success in the treatment of chronic wounds and in particular the diabetic foot. The authors present a retrospective analysis of a device, the BRH-A2, which provides a unique combination of the two therapies. The authors look at the experience across a number of clinics in their home countries.
Methods: This is a retrospective analysis conducted by chart review of patients treated for a DFU with CUSEFS. Three parameters were evaluated. The first was immediate response, where stalled wounds were evaluated after just one and two CUSEFS treatments. The second was an evaluation of the wound care trajectory: Did the wound close 50% within 4 weeks of treatment? The third was total closure at 16 weeks.
Results: Over 80% of the patients showed a positive change in their wound within the first 2 treatments. The average closure during this period was 6%. Almost 70% of the wounds achieved a positive result of 50% closure at 4 weeks. Of those 70% almost 90% achieved total closure at 16 weeks. Of the 30% who did not achieve 50% closure at 4 weeks, 60% achieved total closure at 16 weeks. All of these results were clinically significant.
Conclusion: While an RCT is needed to prove the efficacy of CUSEFS this study shows the effect of the modality to both initiate healing in a previously stalled wound as well as to continue the healing all the way through total wound closure.
Promoting, Altering, and Sustaining Proper Tissue Impedance for Healing of Diabetic Foot Ulcers
Jonathan Rosenblum, DPM1,2, Nachum Greenberg, MD2, and Sean Rosenblum, DPM3
1Bet Shemesh, Israel
2Diabetic Foot Service, Shaarei Zedek Medical Center, Jerusalem, Israel
3Private Practice, Lodi, NJ, USA
Corresponding Author:
Jonathan Rosenblum, DPM, Shimon St 17, Bet Shemesh, Israel 99543.
Email: diabfootman@gmail.com
Introduction: Human skin is an electric field with a constant electron flow. When there is tissue injury there is a leakage of electrons. Acute wounds heal by having an electric bridge across the wound. Chronic wounds lack this conductive electric bridge. In order to assist healing the electroconductivity of the skin and in particular the wound need to be restored. In diabetic skin there is more resistance to this as well as a constant changing of the tissue impedance. The authors describe a unique combine physical modality that provides the adequate impedance in the skin and maintains it throughout treatment, enabling wound healing.
Methods: The authors will show the physical characteristics of the electric field of healthy, injured, and diabetic skin. The authors will demonstrate how these fields exist and are instrumental to wound healing. The authors will describe how the combination of bulk ultrasound waves when combined with constantly alternating electrical waves effect the tissue impedance and conductivity associated with wound healing. The authors will then present clinical evidence supporting this physical data.
Results: DFUs treated with standard electric fields show a + increase in healing rates as compared to baseline. DFUs treated with conventional US also showed a + increase in healing rates. Alternating electric fields showed a ++ increase in healing rates. Alternating EFs when combined with US showed a +++ increase in healing rates.
Conclusion: Understanding and utilization of the body’s electrical field is important in wound healing. A device that can mimic, elevate to, and maintain the body’s electric field would be a very important part of the wound healing armamentarium.
Wearable Muscle Stimulator Reduces the Signs and Symptoms of Diabetic Peripheral Neuropathy
Jonathan Rosenblum, DPM1,2, Sean Rosenblum, DPM3, Dimitry Gimmelreich, MD4, and Valery Karsilnikov, MD5
1Shimon St 17, Bet Shemesh, Israel
2Diabetic Foot Service, Shaarei Zedek Medical Center, Jerusalem, Israel
3Private Practice, Lodi, NJ, USA
4Department of Surgery, Clalit Health Services, Jerusalem, Israel
5Department of Vascular Surgery, Shaarei Zedek Medical Center, Jerusalem, Israel
Corresponding Author:
Jonathan Rosenblum, DPM, Shimon St. 17, Bet Shemesh, Israel.
Email: diabfootman@gmail.com
Introduction: Diabetic peripheral neuropathy (DPN) affects a large percentage of patients with diabetes. Until recently DPN was considered a totally metabolic disease, with small disagreements as to the exact nature of the development of the complication. Recently, there has been agreement that a portion at least of the condition is vascular in nature. This has led to a paradigm shift in the treatment of DPN, with a focus now being on revascularizing and hyperperfusing the affected limb and its innervation. The authors evaluate a novel wearable muscle stimulator, the Flowaid FA-100 SCCD which causes precise contractions of the muscles of the leg and can induce a distal hyperperfusion of the microvasculature.
Methods: The authors took two groups of patients, one with hyperesthetic DPN and one with hypoesthetic DPN. The patients were given the SCCD device to use for 30 days. Baseline NCV, protective sensation, and subjective quality of life and pain data were recorded. After 30 days of twice daily use with the SCCD the measured parameters were again evaluated.
Results: After 30 days there was almost no change in the NCVs of either group of patients. In the group of hyperesthetic patients, pain was decreased by a significant amount. Quality-of-life scores were likewise significantly improved. In the hypoesthetic group, quality-of-life scores significantly improved. In both groups, protective sensation increased significantly. Hours of uninterrupted sleep also increased in both groups.
Conclusion: Because this is a paradigm shift, that DPN is a vascular condition, much more needs to be done to evaluate in theory and in practice. SCCD shows promise as an adjunct therapy for DPN because it is able to hyperperfused the leg with adequate treatment. An RCT with varied subjective and objective endpoints is now being started and other similar studies are recommended to affirm this new hypothesis.
Using Wearable Technology to Assess Foot at Risk of Ulcers Recurrence: A Proof-of-Concept Study
Hyoki Lee, PhD1, He Zhou, PhD1, Hadi Rahemi, PhD1, Jeffry Ross, DPM, MD1, Brian Lepow, DPM1, Joseph Mills, MD1, and Bijan Najafi, PhD1
1Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX 77030
Corresponding Author:
Bijan Najafi, PhD, Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS 390, Houston, TX, 77030.
Email: bijan.najafi@bcm.edu
Purpose: Prolonged immobilization of lower extremities by offloading could cause deterioration in gait performance, which can increase risk of ulcers reoccurrence. The risk could be magnified in frail patients due to slow muscle recovery post–wound healing. This study explored potential application of a wearable sensor to predict foot at risk by quantifying propulsion performance.
Methods: Two healthy subjects with no foot problem (control group) and two patients suffering from diabetic peripheral neuropathy and recent healed ulcers (patients group) were recruited. They were asked to walk at their normal gait speed after wearing their normal footwear. Propulsion performance was quantified using a wearable sensor attached to the subject’s shin. Plantar pressure under regions of interest were measured using computerized pressure insoles. Peak-pressure response to the shin’s angular velocity during population was used to identify foot at risk (Figure 1). Effect size using Cohen’s d was calculated for comparing between groups difference.
Figure 1.
Angular velocity (left) and plant pressure (right) pattern and parameters of interest for a typical healthy subject and a typical subject with high risk of foot problem.
Results: Range of angular velocity during propulsion phase was on average 48% lower in patient group compared to controls, indicating high foot-stiffness during propulsion (140.1 ± 10.5 deg/s for healthy group and 73.1 ± 46.0 deg/s for patients group, d = 2.0). This reduction led to increase in peak-pressure on average by 52% (d = 1.7) and reduce midswing speed by 27%, indicating that increase in foot stiffness during propulsion not only increases the peak pressure but also reduces gait speed. Ratio of peak pressure to angular velocity during propulsion showed a large effect size to identify patient group (1.16 ± 0.51 kPa/(deg/s) for healthy group and 6.45 ± 5.91 kPa/(deg/s) for patients group, d = 1.3). The result showed that the poor proposition performance could magnify plantar pressure and lower gait speed. This in turn may be responsible for increasing risk of recurrence of ulcers.
Conclusions: This proof-of-concept study demonstrated a potential metric to assess foot at risk by evaluating of peak pressure response to foot rotation during propulsion phase. Further study is warranted to validate observations in a larger sample and clinical application of this finding to prevent recurrence of ulcers.
Optimum Footwear Closure Reduces Plantar Stress Response in Free Walk
Hadi Rahemi, PhD1, Ana Enriquez, BS1,2, Joshua Owl1, David G. Armstrong, DPM, MD, PhD2, and Bijan Najafi, PhD1,2
1Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, Baylor College of Medicine, Houston, TX
2Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA
Corresponding Author:
Bijan Najafi, PhD, Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS 390, Houston, TX, 77030.
Email: bijan.najafi@bcm.edu
Purpose: This study examined the impact of shoe closure on plantar thermal stress response (TSR),1,2 which is known to be a surrogate of shear stress and skin perfusion. It is aimed to explore potential impact of shoe closure on increasing risk factors associated with plantar ulcers in people with diabetic peripheral neuropathy (DPN).
Methods: Fifteen eligible healthy subjects were enrolled. The left foot was used as a reference and fitted to a self-adjusted and habitual lace-tightening method by each subject. The right foot was used as a test closure and fitted into three lace-closure conditions: loose, tight, and preset closure (reel clutch). Thermal images were taken after five minutes acclimatization (pretrial) and immediately after 200 walking steps in each shoe-closure condition (posttrial). TSR was calculated from the thermal images.2
Figure 1.
The increase in 95th percentile sole temperatures for the reference closure (blue) and the testing closure conditions (red). The result shows an increase in loose and tight closure conditions and a decrease in optimize closure. The bars attached with the same number of asterisks are statistically similar.
Results: No between feet temperature differences were observed after each acclimatization phase and prior each walking test condition (P > 0.050) indicating appropriate acclimatization. On average, TSR was significantly higher for loose-closure (70.24%, P = .000) and tight-closure (66.85%, P = .007) conditions and lower (–206.53%, P = .000) in the optimized-closure condition (Figure 1) when compared to the reference side (left foot with self-adjusted shoe-closure). No statistically significant difference in TSR was observed between loose-closure and tight-closure conditions (P = .971). The effects results show that TSR only depends on the closure condition and how the shoelaces are tightened and independent of age, gender and BMI (P = .000). The post hoc Tukey’s test on the closure conditions showed that there is no difference between the mean intersole changes in TSR for loose-closure and tight-closure conditions (P = .981); however mean intersole changes in TSR for the optimized-closure was different from both of the loose and the tight conditions (P = .000).
Conclusion: The results suggest that shoelace closure technique can have a profound effect on TSR and that optimum closure may have an impact in reducing risk of plantar ulcers in people with DPN. Interestingly, results revealed that self-adjusted closure may not be necessarily optimum and a preset closure setting like reel clutch might be recommended to minimize risk.
References
1. Wrobel JS, Ammanath P, Le T, et al. A novel shear reduction insole effect on the thermal response to walking stress, balance, and gait. J Diabetes Sci Technol. 2014;8(6):1151-1156.
2. Najafi B, Wrobel JS, Grewal G, et al. Plantar temperature response to walking in diabetes with and without acute charcot: the charcot activity response test. J Aging Res. 2012;2012:140968.
Does Physiological Stress Alter Wound Healing in Patients With Diabetes?
Javad Razjouyan, PhD1, David G. Armstrong, DPM, PhD2, Talal K. Talal, MD3, Joseph L. Mills, MD4, and Bijan Najafi, PhD1
1Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, Baylor College of Medicine, Houston, TX, USA
2Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA
3Hamad Medical Co, Doha, Qatar
4Department of Surgery, Baylor College of Medicine, Houston, TX, USA
Corresponding Author:
Bijan Najafi, PhD, Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS 390, Houston, TX, 77030.
Email: bijan.najafi@bcm.edu
Purpose: The purpose was to examine the association between heart rate variability (HRV) as an indicator of physiological stress response and healing speed (HealSpeed) among diabetic outpatient with active DFUs.
Methods: Ambulatory diabetics with DFUs (n = 25, Age: 59.3 ± 8.3 years) were recruited. HRV during prewound dressing was measured using a wearable sensor attached on participants’ chest. HRVs were quantified in both time and frequency domains to assess physiological stress response and vagal tone. Change in wound size between two consecutive visits was used to estimate HealSpeed. Participants were then categorized into slow/fast healing groups. Between-group comparisons were performed for demographic, clinical, and HRV derived parameters. Associations between different descriptors of HRV and HealSpeed were also assessed.
Results: HealSpeed was significantly correlated with both vagal tone (r = –.705, P = .001) and stress (r = .713, P = .001). No between-group differences were observed except those for HRV derived parameters. Models based on HRVs were the highest predictors of slow/fast HealSpeed (AUC > 0.90) while the models based on demographic and clinical information had poor classification performance (AUC = 0.44).
Conclusions: This study confirmed an association between stress/vagal tone and wound healing in patients with DFUs. In particular, it highlighted the importance of vagal tone (relaxation) in expediting wound healing. It has also demonstrated the feasibility of assessing physiological stress responses using wearable technology in outpatient clinic during routine clinic visits.
Figure 1.
Comparing the speed of wound healing in the two groups: individuals with fast healing speed and those with slow healing speed. The univariate analysis indicated that several heart rate variability parameters are independent predictors between the two groups such as normalized low frequency (nLF), normalized high frequency (nHF), and the ratio of low frequency to high frequency. Analysis is adjusted by wound size at baseline. *Difference is statistically significant (P < .05).
Does Acute Physiological Stress Exist in Neuropathic Patients With Diabetic Foot Ulcers? Evidence From Short-Term ECG Recording by Wearable Sensor During a Wound Clinic Visit
Javad Razjouyan, PhD1, David G. Armstrong, DPM, PhD2, Talal K. Talal, MD3, Joseph L. Mills, MD4, and Bijan Najafi, PhD1
1Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, Baylor College of Medicine, Houston, TX, USA
2Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA
3Hamad Medical Co, Doha, Qatar
4Department of Surgery, Baylor College of Medicine, Houston, TX, USA
Corresponding Author:
Bijan Najafi, PhD, Professor of Surgery, Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS 390, Houston, TX 77030.
Email: bijan.najafi@bcm.edu
Purpose: This study examined the existence of acute physiological stress in the diabetic foot ulcers patients during wound dressing clinical visit.
Methods: Physiological stress was monitored in patients with DFU including prewound dressing (preWD) and wound dressing (WD) periods. Uni-channel electrocardiogram data was recorded by a chest worn sensor.1 Stress fluctuations was quantified by standard deviation (SDNN) of normalized R-to-R intervals (NRR).2 Moderate and high-stress periods were identified when SDNN was in the range of 60–85% and below 60% of baseline SDNN, respectively.1 Vagal tone (indicator of relief from stress) were quantified by the root mean squared of successive of NRR (RMSSD), the power of high-frequency component of NRR (HF%), and the ratio of low frequency to the high-frequency components (LF/HF).
Results: Thirty-five patients (age: 59.3 ± 8.3 years) with DFU were recruited. On average, during clinical visit moderate and high-stress episodes occurred for 29.6 ± 16.6% and 45.5 ± 21.6% of the time respectively. There were trending differences between preWD and WD RMSSD (–12%, P = .058). Significant reductions in HF% (–46%, P = .043) and LF/HF (2.3 folds, P = .022) were observed during WD compared to preWD, indicating a significant increase in physiological stress in response to WD.
Conclusions: The results represent the existence of acute physiological stress during the wound dressing in comparison with the prewound dressing intervals. In the other words, this study confirms that wound dressing is highly stressful despite the lack of foot sensation in the majority of patients with DFU.
Figure 1.
(A) Comparing the time domain heart rate variability during pre–wound dressing (preWD) and during wound dressing (WD). (B) Comparing the frequency domain heart rate variability (HRV) during pre–wound dressing (preWD) and during wound dressing (WD).
References
1. Parvaneh S, Grewal GS, Grewal E, et al. Stressing the dressing: assessing stress during wound care in real-time using wearable sensors. Wound Med. 2014;4:21-26.
2. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Heart rate variability standards of measurement, physiological interpretation, and clinical use. Eur Heart J. 1996;17:354-381.
Cut Point for Smart Insole Alerts Cueing: Will Neuropathic Patients at High Risk of Amputation Be Adherent to Offloading Alerts From Smart Insole-Smart Watch System?
Javad Razjouyan, PhD1, Ana Enriquez, BS1, Ivan Marin, BS1, David G. Armstrong, DPM, PhD2, and Bijan Najafi, PhD1
1Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, Baylor College of Medicine, Houston, TX, USA
2Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA
Corresponding Author:
Bijan Najafi, PhD, Division of Vascular Surgery & Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, MS 390, Houston, TX, 77030.
Email: bijan.najafi@bcm.edu
Purpose: This study examined adherence to alert-based cues for plantar pressure offloading in patients with diabetic foot disease.
Methods: Participants (n = 17) with diabetic peripheral neuropathy and a history of plantar foot ulcers were instructed to wear a smart insole system (the SurroSense Rx®, Orpyx Medical Technologies Inc, Calgary, Canada) over a three-month period. This device is designed to cue offloading to optimize plantar pressures and prevent recurrent foot ulcers. A successful response to an alert was defined as pressure offloading, which occurred within 20 minutes of the alert onset. Patient adherence, defined as daily hours of device wear, was determined using sensor data and patient questionnaires. Changes in these parameters were assessed monthly.
Figure 1.
(A) Those in the high daily alert group (minimum one alert every two hours) showed an improvement in offloading compared to the low alert group in the third month of active device use. (B) Similarly, by the third month, those in the low alert group took longer to notice and/or successfully respond to alerts compared with those in the high alert group. *P < .050.
Results: Patients demonstrating increased adherence over the course of the study received more alerts (0.82 ± 0.31 alerts/hour) than patients whose adherence did not improve (0.36 ± 0.46 alerts/hour, P = .156). By the final stages of the study, participants who had received at least one alert every two hours were more adherent with offloading than participants who received fewer alerts (52.5 ± 4.1% vs 24.7 ± 22.4%, P = .043). Furthermore, duration of time from alert generation to successful offloading was significantly greater in the group receiving fewer alerts. This was measured in the third month with an effect size Cohen’s d = 1.739, P = .043.
Conclusions: The results suggest a minimum number of alerts (one every two hours) is required for patients with diabetic neuropathy to optimally respond to offloading cues from a smart insole system.