Improvement in healing with aggressive edema reduction after debridement of foot infection in persons with diabetes

Background: Infected foot wounds in patients with diabetes are the most common reason for diabetes-related hospital admission in the United States. Nonhealing foot wounds are the major precipitant of lower-extremity amputation in the diabetic population. Hypothesis: The null hypothesis was that there would be no difference in proportion of healing with or without use of a foot-level mechanical compression device. Design: Twelve-week, double-blind, randomized, controlled trial. Setting: A university teaching hospital and related clinics. Patients: One hundred fifteen patients with diabetes, 74% male, with foot infections requiring incision and debridement. Intervention: All patients received either a functioning or placebo (nonfunctioning) foot compression device (Kinetic Concepts Inc, San Antonio, Tex). Patients and investigators were blinded to the functionality of the device. Primary Outcome Measure: Proportion of wound healing in each group. Results: There was a significantly higher proportion of healing in the active group than in the placebo group (39 [75%] of 52 patients vs 23 [51%] of 45; χ²=6.0; P<.02; odds ratio, 2.9; 95% confidence interval, 1.2-6.8). In the placebo group, there was no difference in proportion of healing between those identified as compliant (≥50 hours of use per week) vs noncompliant (P = .10). In patients receiving active units, more patients in the compliant subgroup experienced wound healing (P<.03). When compared as a whole, there was a significant trend toward an increasing proportion of healing from the placebo-noncompliant to the placebo-compliant to the active-noncompliant to the active-compliant groups (χ²(trend) = 8.3; P<.005). Conclusions: Edema reduction achieved in this study by way of a pump and wrap system may increase the proportion of wound healing in patients after debridement of foot infections in patients with diabetes. Furthermore, the data suggest a potential association between increased compliance with use of the device and an increased trend toward wound healing.