Effectiveness of a low-cost indigenous offloading device to enhance wound healing among people with type 2 diabetes: A pilot study from South India
摘要
Effective offloading devices are required to treat DFUs. Literature available on the effectiveness of locally made offloading device in treatment of DFUs is less.
ObjectiveThe aim of the study was to assess and compare the effectiveness of a low-cost indigenous offloading device with an imported offloading device in treating DFUs.
MethodsA randomized clinical study was conducted in a tertiary care center for diabetes between Apr and Nov 2023. Eligible participants were randomized into group 1 (n = 20) and group 2 (n = 22) and were given an imported offloading device and a low-cost indigenously made ankle-length removable offloading device respectively to treat their DFUs. They were followed up at every two weeks till 3rd month or till the end of the wound healing, whichever happened earlier.
ResultsMedian age (63 vs. 58 years; p = .223), duration of diabetes (15.7 vs. 16.8 years; p = .158), and HbA1c% (8.4 vs.9.3%; p = .803) of the participants in group 1 and group 2 were similar at baseline. Wound size reduced significantly in both group 1 (5.9 vs. 1.2 cm2; p < 0.001) and group 2 (3.9 vs. 1.0 cm2; p < 0.001) from baseline to follow-up, but the difference between the groups was not statistically significant (p = .074). Healing time was comparable in both the groups (1 vs. 2; 26.5 vs. 25 median days; p = .503).
ConclusionThe low-cost indigenously made offloading device is found to be equally effective as an imported device in healing of DFUs.