Determinants of healing of diabetic foot ulcer comparing two offloading modalities: A randomized prospective study

Abstract

IntroductionHealing of Diabetic Foot ulcer is crucial to prevent amputation. Offloading is key treatment of diabetic foot ulcers, but choosing which offloading modality is still not clear. Besides, other factors that control ulcer healing, is a question that needs to be determined. Objective: to assess factors that affect ulcer healing, comparing two commonly used offloading devices, removable walker and cast-shoe. MethodsThis is a Randomized Clinical Trial which recruited 87 patients with active diabetic foot ulcers randomly assigned to either a removable walker (W-arm) or a cast-shoe (C-arm) at 3:2 ratio. Both groups received the routine ulcer care, and were followed-up for 24 weeks. Different possible factors related to healing were assessed, and a regression model was built for the most predictive factors. ResultsThe 24-week healing rate was 81% for the walker group and 62 % for the cast-shoe group. The mean adherence was 55 % ± 26 % and 46 % ± 29 for the walker and cast shoe groups respectively. Ulcer healing was significantly positively associated with: better adherence, device type (walker), less SINBAD score (2 or less), absence of ischemia, absence of infection, smaller ulcer area, superficial ulcer, better 4-week area reduction, and better blood glucose control. The most important predictors were adherence, total SINBAD score and 4-week area reduction. ConclusionSINBAD score at initial presentation and the degree of adherence to offloading device, are two major determinants of ulcer healing. Ulcer area reduction at 4 weeks represents an important clinical parameter to predict and guide the success of ulcer management.