Dg. Armstrong et Hc. Nguyen, Improvement in healing with aggressive edema reduction after debridement of foot infection in persons with diabetes, ARCH SURG, 135(12), 2000, pp. 1405-1409
Background: Infected foot wounds in patients with diabetes are the most com
mon reason for diabetes-related hospital admission in the United States. No
nhealing foot wounds are the major precipitant of lower-extremity amputatio
n in the diabetic population.
Hypothesis: The null hypothesis was that there would be no difference in pr
oportion of healing with or without use of afoot-level mechanical compressi
on 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 i
nfections requiring incision and debridement.
Intervention: All patients received either a functioning or placebo (nonfun
ctioning) 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 acti
ve 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 bet
ween those identified as compliant (<greater than or equal to>50 hours of u
se per week) vs noncompliant (P=.10). In patients receiving active units, m
ore patients in the compliant subgroup experienced wound healing (P<.03). W
hen compared as a whole, there was a significant trend toward an increasing
proportion of healing from the placebo-noncompliant to the placebo-complia
nt to the active-noncompliant to the active-compliant groups (<chi>(2)(tren
d)=8.3; P<.005).
Conclusions: Edema reduction achieved in this study by way of a pump and wr
ap system may increase the proportion of wound healing in patients after de
bridement of foot infections in patients with diabetes. Furthermore, the da
ta suggest a potential association between increased compliance with use of
the device and an increased trend toward wound healing.