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QUESTION: Does aggressive oedema reduction with a foot level mechanical compression device improve healing of foot infection in patients with diabetes mellitus?
Design
Randomised {allocation concealed*}†, blinded (investigators and patients),* controlled trial with 12 weeks follow up.
Setting
University teaching hospital and related clinics in San Antonio, Texas, USA.
Patients
115 patients with diabetes who had foot infections requiring incision and debridement. Exclusion criteria were congestive heart failure, advanced renal disease, serum creatinine concentration >177 μmol/l, or planned lower extremity bypass graft surgery. 97 patients (84%) (mean age 50 y, 74% men) had complete follow up.
Intervention
Patients were allocated to receive a functioning (active group, n=59) or non-functioning (placebo group, n=56) …
Footnotes
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Source of funding: Kinetic Concepts Inc, San Antonio, Texas.
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For correspondence: Dr D G Armstrong, Department of Surgery, Southern Arizona Veterans Affairs Medical Center, 3601 South Sixth Avenue, Tucson, AZ 85723, USA. Fax +1 781 823 6628.
↵† Information provided by author.