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; chi(2) = 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 (chi(2)(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. Arch Surg. 2000;135:1405-1409