The purpose of this randomized, double-blind placebo controlled study was to evaluate the proportion of healing of subjects using intermittent foot compression following foot-level debridement of diabetic foot infections. We identified and enrolled 115 patients, 74% male, with diabetic foot infections requiring emergent incision and debridement. All patients received either a functioning or placebo (non-functioning) foot compression device (Kinetic Concepts Incorporated, San Antonio, Texas, USA). Patients and investigators were blinded to the functionality of the device. Patients were followed for twelve weeks, with the primary outcome measure being the proportion of wound healing in each group. There was a significantly higher proportion of healing in the active group compared with placebo (75.0% vs. 51.1%, x2=6.0, p <0.02, OR=2.9, CI=1.2-6.8). In the placebo group, there was not a difference in proportion of healing between those identified as compliant (50 or more hours/week of use) versus non-compliant (p=0.1). In patients receiving active units, more patients healed in the compliant subgroup compared with the non-compliant subgroup (p< 0.03). When compared as a whole, there was a significant trend toward increasing prevalence of healing moving from “placebo-non-compliant” to “placebo-compliant” to “active-non-compliant” to “active compliant” groups (x2trend=8.3, p<0.005). The results of this study suggest that the use of intermittent pulsatile foot compression delivered by a pump and wrap system may increase the proportion of wound healing in patients following debridement of diabetic foot infections. Furthermore, the data suggest a potential association between increased compliance with use of the device and an increased trend toward wound healing.
Learning Objectives: Describe the results of a placebo-controlled randomized clinical trial of wound healing using a device designed to limit swelling
Keywords: Diabetes, Interventions
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.