Question: In patients who have diabetes mellitus
and edema with foot ulcers requiring débridement, how effective
is intermittent pneumatic foot compression after débridement
in promoting wound-healing?
Design: Randomized, double-blind, placebo-controlled
trial with 12-week follow-up.
Setting: University hospital and clinics in San
Antonio, Texas, USA.
Patients: 115 patients who had diabetes mellitus
and foot infections requiring incision and débridement.
Patients were excluded if they had active congestive heart failure,
end-stage renal disease, or a serum creatinine level of >177
mol/L at hospital admission, or if they received a lower-extremity
bypass graft during the study. 97 patients (84%) (mean age,
50 years; 74% men) completed the study.
Intervention: Patients were allocated to a functioning
(n = 52) or placebo (n = 45) pulsatile
pneumatic foot compression system (Kinetic Concepts, Inc.,
San Antonio, Texas, USA). The functioning pump sent intermittent
bursts of air through tubing to a wrap encircling the foot. The
bladder in the wrap rapidly inflated to 160 mm Hg for 2 seconds,
and the cycle was repeated every 20 seconds. The placebo wrap did not
inflate. The patients were instructed to use the device approximately
8 hours/day.
Main outcome measures: Rate of complete wound-healing (complete
epithelialization) and compliance (50 hours of use/week).
Results: Complete wound-healing was achieved in
more patients in the functioning-pump group than in the placebo-pump
group (P < 0.02) (table). Time to wound-healing was less
in the functioning-pump group (P = 0.04). In the functioning-pump
group, healing was achieved in more of the patients who were compliant
than in those who were noncompliant (P = 0.03).
Healing did not differ among patients in the placebo group, regardless
of whether they were compliant or noncompliant (P = 0.10).
Conclusion: In patients with diabetes mellitus and
edema with foot ulcers requiring débridement, intermittent
pneumatic foot compression after débridement promoted wound-healing.