. 2017 Sep 21;17(12):1–124.

Table A2:

Design and Characteristics of the Randomized Controlled Trials

Author, Year Country N (intervention/control) Funding Follow-up	Population	Methods	Intervention	Comparator	Other Treatment Procedures	Outcomes
Najafi et al, 2016³⁰ United States 49 (23/26) Qatar National Research Foundation 3 months or complete ulcer healing—whichever came first	Diabetes Noninfected, nonischemic foot ulcers, plantar neuropathic foot ulcers Age >18 years Excluded: peripheral arterial disease; major foot amputation; active Charcot arthropathy	Computer-generated randomization Sequentially numbered, opaque envelopes kept at the site Analyses: Chi-square or Fisher's exact test for proportions; Spearman correlation for the association between patient characteristics and outcomes	Removable cast walker (DH Offloading Walker) Patients instructed to cleanse wound daily and apply a dressing Instructions to inspect the wound with dressing change and how to detect signs of worsening Instructions not to walk without the device	Irremovable cast walker (DH Offloading Walker wrapped with a cohesive bandage) Wound care similar to intervention group, but weekly cast walker reapplication	Standard treatment: wound debridement, moisture-retentive dressings	Ulcer size reduction Percent healed ulcers Daily physical activity Largest ulcer used for outcome assessment if >1 ulcer present
Piaggesi et al, 2016²⁸ Italy 65 (23/22/20) No funding support 3 months or complete ulcer healing—whichever came first	Diabetes type 1 or 2 >5 years' duration Forefoot plantar ulcers grades >1 cm² Lasting >6 weeks Grades 1A or 2A^a Peripheral neuropathy Excluded: peripheral arterial disease; osteomyelitis; contralateral ulcers; Charcot foot; lower limb edema; previous amputations in the affected or contralateral limb; metabolic decompensation; BMI >35 kg/m²	Consecutive patients Computer-generated randomization Outcome assessor was blinded to treatment group Analyses: nonparametric f-tests for continuous variables; Kaplan-Meier test for survival data; chi-square, Fisher's exact tests for proportions	Fibreglass total contact casting (Softcast 3M and Scotchcast 3M) Padding over the ulcer	Irremovable cast walker (Optima Diab) using dedicated straps provided by manufacturer Removable cast walker (Optima Diab) Hole cut in the intermediate layer of the insole in the location of the ulcer to reduce pressure	Standard treatment for neuropathic ulcers Debridement Inert hydrofibre dressing Patient education on how to use devices Weekly reinforcement of the importance of adherence (wearing the removable cast walker at all times)	Ulcer survival^b Time to healing Ulcer size reduction Percent healed ulcers Complications Patient satisfaction (VAS 0–10)
Lavery et al, 2015¹⁶ United States 73 (23/27/23) United States National Institutes of Health 3 months or complete ulcer healing—whichever came first	Diabetes Grades 1A or 2A forefoot plantar ulcers^a Excluded: severe peripheral vascular disease; untreated osteomyelitis; Charcot arthropathy with severe residual deformity that would not permit the use of a walker boot	Computer-generated randomization Single-blinded Analyses: ITT and per-protocol analysis; chi-square test for proportions; multivariate ANOVA for continuous outcomes; power calculation not reported	Fibreglass total contact casting (personal communication with the author) Frequency of cast change NR	Shear cast walker (Glidesoft) Healing sandals (Sroufe Deluxe Chevron shoe with 8 mm Plastazote insole)	Debridement Hydrogel dressing Fine-mesh gauze for covering the wound Patients assessed every 7–10 days	Percent healed ulcers^b Patient satisfaction (VAS 0–10) Patient activity level Complications Reasons for withdrawal Largest ulcer used for outcome assessment if >1 ulcer present
Gutekunst et al, 2011³³ United States 23 (11/12) United States National Institutes of Health Follow-up NR	Diabetes Peripheral neuropathy >1 incident plantar foot ulcer (Grade 1–2)^c Excluded: wound infection; lower-extremity ischemia or cellulitis	Com puter-generated randomization Open-label Analyses: chi-square test for proportions; f-test for continuous variables; power calculation not performed because no difference was expected between groups	Total contact casting (plaster and fibreglass mix) Frequency of cast change NR	Removable cast walker	Antimicrobial sock Pressure-measuring insole in offloading device for both groups	Offloading capacity^b Percent healed ulcers Time to ulcer healing
Faglia et al, 2010³⁴ Italy 45 (23/22) Contributions from the removable cast walker manufacturer 3 months	Neuropathic plantar forefoot ulcer Grade 1A^a Excluded: peripheral neuropathy; clinical signs of infection; osteomyelitis; impaired balance; contralateral foot ulcers	Consecutive patients Randomization using sealed envelopes Open-label Analysis: Kaplan-Meier test/log-rank test for time to healing	Total contact casting (Softcast 3M and Scotchcast 3M) German cotton Tubular stockinet Protective layer of rubber foam to protect bony protrusions Stick made of Scotchcast bandage in the middle of the two malleoli, extending for 20 cm to provide rigidity Rigid plantar sole built with same material as stick Aluminum stirrup for walking Device removed and dressing changed weekly	Removable cast walker with rigid, boat-shaped, full rocker-bottom sole (Stabil D) Device removed and dressing changed weekly	Debridement Paraffin gauze dressing	Ulcer area reduction^b Percent healed ulcers Time to ulcer healing
Van de Weg et al, 2008³⁵ Netherlands 43 (23/20) Partially funded by a manufacturer; unclear whether it was the manufacturer of any of the devices used in the study 4 months	Diabetes Plantar ulcers grades 1 or 2^c Peripheral neuropathy Excluded: peripheral arterial disease; osteomyelitis	Randomization using opaque sealed envelopes Ulcer measurement performed by blinded assessor (not easy to maintain) Time of ulcer healing, self-reported Analyses: ITT; type of analysis not provided for outcomes other than ulcer area reduction; power calculation based on ulcer area reduction	Total contact casting (unclear if fibreglass) Adhesive foam over bony prominences Cast shoes with polyphasic rocker Crutch/cane to maintain balance if poor posture stability Cast changed weekly	Custom-made temporary shoe Felt, rigid leather socket stiffened with Rhenoflex Education on the importance of adherence	Debridement Hypertrophic edges removed Dressing (Aquacell) application Antibiotic if necessary	Ulcer area reduction^b Time to healing Percent healed ulcers Complications Reasons for withdrawal Largest ulcer used for outcome assessment if >1 ulcer present
Caravaggi et al, 2007³² Italy 58 (29/29) Funding information NR 3 months	Diabetes Neuropathic ulcer of the plantar surface Included ulcers correlated with Charcot neuroarthropathy deformities Excluded: superficial tissue infections; osteomyelitis; TcPO₂ >30 mm Hg; peripheral arterial disease; severe visual deficit; amputation of contralateral limb	Consecutive patients Randomization procedure not reported Analyses: Kaplan-Meier to estimate time to healing and healing rate; Fisher's exact test for proportion of ulcer healing; power calculation not reported	Fibreglass total contact cast (Softcast 3M and Scotchcast 3M) Included rubber heel for walking for forefoot ulcers Walking stirrup for midfoot ulcers Frequency of cast changes not provided Before casting: German cotton application, especially over bony protrusions; stockinet on lower limb	Removable cast walker (Aircast Pneumatic Walker, XP Diabetic Walker) Reminder to adhere to treatment at every visit	Surgical debridement every 12 days Dressing: mesh of hyaluronic acid covered with polyurethane foam	Ulcer surface area reduction Time to healing Percent healed ulcers Reasons for withdrawal
Piaggesi et al, 2007²⁹ Italy 40 (20/20) Contributions from the removable cast walker manufacturer 3 months or ulcer closure—whichever came first	Diabetes (type 1 or 2) >5 years Peripheral neuropathy Forefoot plantar ulcer >3 weeks Grade 1A or 2A,^a area >1 cm² Excluded: peripheral vascular disease; infection, edema; osteomyelitis; Charcot neuroarthropathy	All patients attending the foot clinic were screened for eligibility Computer-generated randomization Analyses: ITT analysis; Student's f-test and Kaplan-Meier for survival data; chi-square tests for proportions	Fibreglass total contact casting (Softcast 3M and Scotchcast 3M) Layer of isolating foam over ulcer Layer of cotton wool 1–2 rubber heels for walking Changed every week	Cast walker (Optima Diab) rendered irremovable by using a plastic nonremovable lace Layer of cotton wool 3-layer insoles Changed every week Patient education on how to use device	Standard treatment for neuropathic ulcers Surgical debridement Paraffin gauze dressing, then covered with sterile gauze Patient education on how to use device	Percent healed ulcers^b Mean healing time Complications Patient satisfaction (VAS 0–10) Length of procedure Cost of treatment (materials)
Katz et al, 2005³⁶ United States 41 (20/21) Contributions from the walker manufacturer 3 months or ulcer healing—whichever came first	Diabetes Chronic (>7 days with surrounding area of callus), noninfected, nonischemic stage IA or 2A^a ulcers Peripheral neuropathy Excluded: Charcot arthropathy	Consecutive patients Randomization using a random number table Analyses: log-rank test for survival data; t-test for dichotomous variables; 95% power for 5% difference in primary outcome; 35% power for 25% in complication rates	Total contact casting (unclear if fibreglass) Device replaced every week	Irremovable cast walker (removable cast walker [Royce Medical] wrapped in fibreglass casting material) Device replaced every week	Debridement as needed Dressing application Weekly follow-up	Percent healed ulcers^b Time to healing Complications Time to place and remove devices Cost
Armstrong et al, 2005³⁷ United States 50 (25/25) United States Department of Veteran Affairs 3 months or ulcer healing—whichever came first	Diabetes Peripheral neuropathy Forefoot plantar ulcer Grade 1A ulcer^a Lack of severe peripheral vascular disease Lack of active infection	Computer-generated randomization Analyses: Kaplan-Meier life table analysis (logrank test); chi-square test for dichotomous variables; power calculation provided	Irremovable cast walker: removable walker (Active Offloading Walker; Royce Medical) wrapped entirely in a cohesive bandage	Removable cast walker (Active Offloading Walker; Royce Medical)	Surgical debridement as needed Weekly follow-up for device inspection, wound care, and debridement Patients instructed to wear their devices during ambulation	Percent healed ulcers Time to healing Largest ulcer used for outcome assessment if >1 ulcer present
Armstrong et al, 2001³⁸ United States 63 (19/20/24) United States Department of Veterans Affairs 3 months or ulcer healing—whichever came first	Neuropathic diabetic plantar foot ulcer Noninfected, Grade 1A^a At least one palpable foot pulse or TcPO₂ >40 mm Hg at dorsum of forefoot Excluded: inability to walk without wheelchair assistance; wounds on the heel, rear foot, or nonplantar; severe peripheral vascular disease	Computerized randomization schedule Analyses: ANOVA with correction for multiple comparisons for continuous variables; chi-square test for dichotomous variables; Kaplan-Meier with logrank test for survival outcomes	Total contact casting (fibreglass and plaster) Casting change frequency NR (weekly wound inspection)	Removable cast walker (Aircast) Half-shoe (Darco, WV)	Wound care and debridement Surgical debridement if needed Weekly visits	Percent healed ulcers^b Time to healing Reasons for withdrawal Activity level^b Quality of life (SF-36) in separate publication⁴⁰ Largest ulcer used for outcome assessment if >1 ulcer present
Caravaggi et al, 2000³¹ Italy 50 (26/24) Funding information not available 30 days	Diabetes Peripheral neuropathy Plantar ulcers Excluded: deep or superficial tissue infections; osteomyelitis; peripheral arterial disease; severe balance problems; severe visual deficit; other foot skin lesions; plantar bilateral ulcers; amputation of a limb	Consecutive patients Centralized randomization Analyses: chi-square test for dichotomous variables; f-test for continuous variables; power calculation based on healing rate outcome	Fibreglass total contact cast (Softcast 3M and Scotchcast 3M) Stick made of Scotchcast 3M in the middle of the two malleoli extending for 20 cm to provide rigidity Rigid plantar insole built of same material as stick Aluminum stirrup or rubber heel, depending on position of the ulcer, to allow walking Elevation of the opposite foot to ease walking, patient training Before casting: German cotton especially over bony protrusions; stockinet on lower limb	Therapeutic shoes with rocker-bottom sole Plastazote insole with an area of offloading Unaffected foot received the same shoe without the offloading area Dressing changes every 2 days	Surgical debridement if necessary Paraffin gauze dressing	Ulcer healing rate^b Percent healed ulcers Patient acceptance (VAS 1–100) Complications
Mueller et al, 1989³⁹ United States 40 (21/19) Funded by the Foundation for Physical Therapy Unclear (approximately 90 days based on ranges for ulcer healing)	Diabetes Peripheral neuropathy Plantar ulcers Grade 1–2^d No gross infection Excluded: osteomyelitis; gangrene	Tested the hypothesis of no difference in ulcers healed or time to healing between groups No details about randomization procedure Analysis: chi-square test for dichotomous variables	Total contact cast (plaster [inner layer] and fibreglass) Inner layer: plaster shell reinforced by plaster splints Outer layer: fibreglass for durability and to allow weight bearing sooner Walking heel attached Assistive devices (walkers, crutches) provided if needed First cast change 5–7 days after initial application; if no complications, changes every 2–3 weeks	Traditional dressing treatment Healing sandal, extra-depth shoe with Plastazote insert Dressing change 2–3 times daily; nurse home visit for dressing change if needed Follow-up every 2–4 weeks	—	Percent healed ulcers Time to healing Complications

Abbreviations: ANOVA, analysis of variance; BMI, body mass index; ITT, intention-to-treat; NR, not reported; SF-36, Short-Form 36-item health survey; TcPO₂, transcutaneous oxygen; VAS, visual analogue scale.

University of Texas Classification of Diabetic Wounds.⁴²

Primary outcome.

Wagner Foot Ulcer Grading System.⁶⁵