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; 
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 (2trend = 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.
