Impact of multidisciplinary foot care team on outcome of diabetic foot ulcer in term of lower extremity amputation at a tertiary care unit in Karachi, Pakistan

Abstract

To compare the outcomes of diabetic foot ulcers (DFU) in terms of healing and lower extremity amputation (LEA) rate before and after training of multidisciplinary foot care team (MDFCT). Subjects were categorised into two groups; Group‐A cases seen between 1997 and 2006 (before upgrading of training and services of MDFCT) and Group‐B cases seen between 2007 and 2016 (after upgrading of training and services of MDFCT). Baseline demographic characteristics, biochemical results, and outcomes of DFU in terms of healing or amputation were analysed by using statistical package social science (SPSS) version 20. Total 7994 DFU cases seen, 888 in group A and 7106 in group B. Mean age of patients was 53.80 ± 10.40 years and mean haemoglobin (HbA1c) was 10.12 ± 2.44. Overall, decreasing trends of amputations were observed from baseline 27.5% to 3.92% during the period of 20 years. In group A, 479 (78.8%) subjects healed completely compared with 3806 (89.1%) in group B. Significant reduction in toe amputations ([13.81%] vs [8.11%]) and below knee amputations [(5.26%) vs (1.82%)] were seen. Similarly, rates of above knee amputation ([1.80%] vs [0.35%] P‐value 0.008) in two groups was also significant. Significant improvement was observed in outcomes of DFU in terms of amputation through multidisciplinary team approach.

1. INTRODUCTION

Diabetic foot ulcer (DFU) leading to lower extremity amputation (LEA) is one of the common complications of diabetes mellitus (DM).1 DFUs are complex, chronic wounds, which have a major long‐term impact on the morbidity, mortality, physical distress, as well as financial losses that lower the quality of subjects' lives.2 Lack of knowledge regarding diabetic foot care, absence of an effective primary health care system and poor socio‐economic status contributes to higher rates of diabetic foot ulcers in developing countries.3

According to International Diabetes Federation (IDF), 425 million people worldwide are suffering from DM.4 The global prevalence of DFU is 6.3%, while in North America, Asia, Europe, Africa, and Oceania it is 13.0%, 5.5%, 5.1%, 7.2%, and 3.0%, respectively.5 In the United States, 15% to 25% subjects with diabetes develop DFU in their lifetime.6 National Diabetes Survey of Pakistan (NDSP 2016‐2017) has estimated the prevalence of diabetes to be around 26.3%.7 Previously, it was also reported that 10% diabetic subjects suffer from diabetic foot ulceration.8, 9 DFU is difficult to treat because of various diabetes‐related etiopathological problems like venous insufficiency, peripheral arterial disease (PAD), offloading plantar foot pressures and peripheral neuropathy.10

Previous studies estimated that LEA occurs 10 to 30 times more frequently in diabetic subjects compared with non‐diabetic subjects.11 It has also been observed that 70% of lower limb amputations follow foot ulceration.12 However, in Pakistan despite a comparable prevalence of diabetic foot ulceration, the amputation rate (number of amputations because of diabetes per year) has been reported to be 21%–48%.13 DFUs management requires a thorough knowledge of the major risk factors for amputation, frequent routine evaluation, foot screening and conservative management of foot pathologies. It has been shown that a multidisciplinary team not only reduce amputation rates by 50% to 85% but also decrease the risks associated with DFU, which in turn leads to better quality of life.14, 15

To the best of our knowledge, in Pakistan, the first diabetic foot clinic was established in 1996 at Baqai Institute of Diabetology and Endocrinology (BIDE), a tertiary care diabetes centre with the concept of MDFCT. But, in 2006 upgrading services was developed including diabetologists, surgeons with special interest in diabetic foot and foot care assistants. So, the purpose of this study was to compare the outcomes of diabetic foot ulcers in terms of healing and LEA rate in subjects, before and after training of MDFCT at a tertiary care unit of Karachi, Pakistan.

2. METHODOLOGY

This retrospective cross‐sectional study was conducted at BIDE, a tertiary care unit of Karachi, Pakistan. All subjects with DFU attending the foot clinic of BIDE from January 1997 to December 2016 were included in the study. Subjects expired during the study, lost to follow‐up and who were unable to complete the treatment were excluded. Data were extracted from the hospital management system (HMS) for analysis and categorised into two groups. Group A; cases seen between 1997 and 2006 (before the upgrading services of MDFCT) and Group B; cases seen between 2007 and 2016 (after upgrading of training and services of MDFCT).

Initially, diabetologist played an important role in managing this clinic without proper foot care assistants and surgeons. In the earlier study period (1997‐2006), health care staff and patients had limited knowledge regarding proper management of DFU. During this, the Physicians were trained in diabetic foot surgery. A mini theatre was established and use of Neurothesiometer and hand‐held Doppler was introduced. Diabetic foot care assistants (DFCAs) were trained to provide diabetic foot care under medical supervision. Training of footwear technicians was conducted under the supervision of international experts. Standard operating procedure (SOPs) were developed, collaboration with general surgeon, orthopaedic surgeon, vascular surgeons were brought. Interventional radiologists were involved in the management of DFU. Other cost‐effective strategies included manufacturing and distribution of low‐cost offloading devices developed with locally available material.16 Domiciliary foot care service and stationed 24‐hour phone helpline service was also established to improve the compliance of DFU.

Details of basic demographic characteristics of subjects including age, gender, duration of diabetes, body mass index (BMI), systolic and diastolic blood pressure, history of foot ulceration, and type of foot ulceration were recorded on the first visit. Biochemical result and outcomes of diabetic foot ulcers in terms of healing or amputation were also obtained. Amputation was defined as the complete loss of the transverse anatomical plan of any part of the lower limb. Amputations ended above the ankle if proximal to tars‐metatarsal joint were defined as major while amputations below the ankle if distal to this joint were defined as minor amputations.17 Type of ulcers were categorised as neuropathic and neuroischaemic or ischaemic. PAD is an independent risk factor for CVD and a reduced ankle brachial pressure index (ABPI) (<0.9) is associated with twice the risk of cardiovascular mortality compared with matched patients with a normal ABPI. Handheld Doppler is used for screening purposes. Patients are further referred for duplex ultrasound Doppler and CT‐angiography as needed. Peripheral neuropathy was quantified assessing vibration sensation using a 128 HTZ tuning fork and 10 g monofilament applied perpendicularly to the plantar aspect of the first toe, the first, third, and fifth metatarsal heads, the plantar surface of the heel and dorsum of the foot avoiding any callus, corn or wound site and graded as normal, diminished or absent.13, 18

Height was measured to the nearest of 0.1 cm, while subject standing in erect posture and weight was measured with portable weighing scale nearest of 0.1 kg. Body mass index (BMI) was measured as the ratio of weight (kg) to height squared (m²). As per Asian guideline, subjects having BMI ≥ 25 (kg/m²) were labelled obese.19 Blood pressure of the participants was monitored by mercury sphygmomanometer in a sitting position by using the standard method. Hypertension was defined as blood pressure ≥ 130/85 mm Hg.20 Glycaemic control was assessed by measuring glycosylated haemoglobin A1c (HbA1c) by high‐performance liquid chromatography method on a Bio‐Rad D‐10.

All calculations were performed using statistical package for social science (SPSS) version 20. The data were expressed as mean ± SD and percentages. Student t test and χ ² test were used for frequency variables. Statistical significance was defined as P < 0.05.

3. RESULTS

Total of 7994 cases with DFU seen during the study period, 888 in group A and 7106 in group B with the mean age of 52.70 ± 10.30 and 53.84 ± 10.47 years respectively. Sixty‐six percent subjects were males in group A and 71.4% in group B. Mean duration of diabetes in group A and B was 12.80 ± 6.90 and 11.95 ± 7.90, respectively. Most of the subjects had poor glycaemic control at presentation with a mean HbA1c of 9.79 ± 2.28 in group A and 10.17 ± 0.2.48 in group B. Regarding type of foot ulcer (51.7%) in group A and (87.4%) in group B had neuropathic ulcer, while (48.3%) and (12.6%) subjects had neuroischaemic/ischaemic ulceration in group A and group B, respectively. Similarly, history of foot ulceration was observed in (46.7%) in group A and (35.6%) in group B (Table 1).

Table 1.

Baseline characteristics of subjects with diabetic foot ulcers

Variables	Group A	Group B	P‐value	Total
Number of cases	888	7106		7994
Gender
Male	583 (65.7%)	5073 (71.4%)	0.0005	5656 (70.7%)
Female	303 (34.3%)	2033 (28.6%)		2336 (29.3%)
Age (year)	52.70 ± 10.30	53.84 ± 10.47	0.002	53.80 ± 10.40
Duration of diabetes mellitus (year)	12.80 ± 6.90	11.95 ± 7.90	0.002	11.95 ± 7.87
Body mass index (kg/m2)	26.66 ± 5.43	27.01 ± 5.68	0.248	26.99 ± 5.67
Systolic blood pressure (mm Hg)	129.85 ± 18.34	131.73 ± 17.55	0.023	131.60 ± 17.61
Diastolic blood pressure (mm Hg)	80.20 ± 9.83	81.83 ± 9.19	<0.0001	81.71 ± 9.24
Hemoglobin A1c (HbA1c) (%)	9.79 ± 2.28	10.17 ± 0.2.48	<0.0001	10.12 ± 2.44
HbA1c (mmol/mol)	83	87		87
Type of ulcer
Neuropathic	453 (51.7%)	6164 (87.4%)	<0.0001	6617 (83.5%)
Neuroischaemic/ischaemic	423 (48.3%)	886 (12.6%)		1309 (16.5%)
Neuroischaemic		812 (11.5%)
Ischaemic		74 (1.1%)
Previous history of foot ulcer
No	472 (53.3%)	4576 (64.3%)	<0.0001	5048 (63.2%)
Yes	414 (46.7%)	2530 (35.6%)		2944 (36.8%)

Data presented as mean ± SD or n (%).

P‐value <0.05 was considered statistically significant.

In group A (78.8%) subjects healed completely whereas (89.1%) healed completely in group B (P < 0.0001). Out of 89.1%, most of the patients in group B were healed with neuropathic (91.6%) followed by neuroischaemic (7.9%) and ischaemic (0.5%). Statistically significant reduction in the number of toe amputations ([13.81%] vs [8.11%], P‐value 0.042) and below knee amputations ([5.26%] vs [1.82%], P‐value 0.03) were seen in group A vs B, respectively. ]Similarly, the rates of above knee amputation ([1.80%] vs [0.35%] P‐value 0.008) in both groups was also significant (Table 2).

Table 2.

Outcome of subjects with diabetic foot ulcers

Outcomes	Group A	Group B	P‐value	Overall
n	608	4274	—	4882
Healed	479 (78.8%)	3806 (89.0%)	<0.0001	4285 (87.77%)
Toe amputation	84 (13.81%)	347 (8.11%)	0.042	431 (8.82%)
Trans metatarsals	2 (0.3%)	28 (0.65%)	0.041	30 (0.61%)
Below knee amputation	32 (5.26%)	78 (1.82%)	0.03	110 (2.25%)
Above knee amputation	11 (1.80%)	15 (0.35%)	0.008	26 (0.53%)

Data presented as mean ± SD or n (%).

P‐value <0.05 was considered statistically significant.

^aLAMA/lost to follow‐up and expired were excluded from the final analysis.

Figure 1 shows the trends of amputation from 1997 to 2016. Decreasing trends of amputations were observed from high baseline of 27.5% (1997‐2003)13 to 10.39% (2004‐2006) and 8.32% (2007‐2010) to 7.81% (2011‐2013) to 3.92% (2014‐2016). Similarly, decreasing trends of major amputations were observed 10.2% (1997‐2003) to 1.4% (2014‐2016) and minor amputation 17.3% (1997‐2003) to 2.5% (2014‐2016).

Figure 1.

Trends of amputation rate of last two decades at a tertiary care unit

4. DISCUSSION

The present study demonstrates that rate of amputation was significantly lowered after the introduction of multidisciplinary team in the treatment of DFU. This study, to the best of our knowledge is the first from Pakistan to report a comparative reduction in amputations rate before and after introducing the upgrading services of an MDFCT in diabetic foot clinic. A higher amputation rate in individuals with diabetes, especially among men compared with women, is similar to other studies. In our centre, there was a dramatic fall in LEA from a high baseline of 27.5% (10.2% major and 17.3% minor) to 3.9% (1.4% major and 2.5% minor). In Denmark, there was a significant fall for 27.2 major amputation per 100 000 of the general population to 6.9, our baseline compares well with this and also with other major amputation data for other UK centres.21, 22 We achieved 3.9% amputation rate which is comparable with the lowest published rate of 2.2 for Medical and 2.8 for the United Kingdom.15, 23

Risk of amputation in subjects with DFU varies with the severity of ulcer at presentation as assessed by grading and staging of foot ulcer. Subjects presenting at lower grades usually have mild foot problems; therefore, the amputation rate was low with good prognosis. However, subjects with higher grades of ulcer at presentation were at higher risk of amputation with poor prognosis. Amputation is considered not only a marker of disease but also of disease management.24 A number of changes and improvement were gradually introduced in our centre to improve the outcome of DFU. Diabetic foot care assistants (DFCAs) were trained and a domiciliary dressing system was developed to ensure compliance and to cut down the commuting cost. Time to time, many changes are made for good clinical management of DF disease. These data reaffirm that the organisation of care is one of the main determinants of the outcome of diabetic foot ulcers. There are number of studies which demonstrate the effectiveness of multidisciplinary foot care services regarding prevention of foot ulcer thus decreasing amputation rate.15, 22, 23 Levery et al observed that implementing a lower extremity disease management program consisting of screening and treatment protocols for diabetic patients in managed care organisation decreased the incidence of amputation by 47.4%.25, 26 However, these studies are reported for developed countries with well‐established multidisciplinary diabetic foot care centres. The situation is totally different in developing countries with a lack of effective primary care, late referred to secondary and tertiary care hospitals, delay in initiating of diabetic foot patient's treatment leads to high amputation rate, most of which could have been avoided. We have scientifically assessed the impact of such interventions in reducing amputation rate in outpatient's department. This decrease in amputation rate is very likely to be multifactorial.

We analysed the amputation rate of DFU subject's year wise to assess the impact of MDFCT. In the year 1997, when the foot clinic was started the amputation rate was 27.5%. In the earlier studies, lack of proper screening facilities for diabetic foot regarding neuropathy, vasculopathy, high plantar pressures plus at‐risk foot and lack of awareness regarding diabetic foot problem may have contributed to this high amputation rate. However, with gradual improvement in the knowledge of our foot care treatment plus specialised training courses performed by our doctors as well as foot care assistants, plus upgradation of services including identification of at‐risk foot by use of Neurothesiometer, ABI in every patient using hand‐held Doppler, assessment of foot pressures by Pedometer, plus involvement of various specialties like vascular surgeon, orthopaedic, intervention radiologists, etc. have significantly contributed in the rate reduction. Raising awareness of the at‐risk foot was also a significant factor.

Our study has some limitations. The results of the present study are only from one centre which might not be representative of whole country. Second, although we demonstrated a reduction in amputation rate following introduction of multidisciplinary team, other factors may also have contributed such as compliance of treatment, early referral to our centre because of increasing awareness etc.

Overall, significant improvement was observed in outcomes of diabetic foot ulcer in terms of amputation following improvement and upgradation of foot care services through multidisciplinary team approach.

Riaz M, Miyan Z, Waris N, et al. Impact of multidisciplinary foot care team on outcome of diabetic foot ulcer in term of lower extremity amputation at a tertiary care unit in Karachi, Pakistan. Int Wound J. 2019;16:768–772. 10.1111/iwj.13095