[Triple-blind clinical trial with placebo control to evaluate the efficacy of a heparin of low molecular weight (bemiparin) for treating slow-responding ulcers in diabetic foot in primary care]

Abstract

Objectives: To establish the degree of efficacy of bemiparin treatment over 3 months in the improvement of slow-responding ulcers in diabetic foot. Also, to evaluate the safety of bemiparin and quality of life and to compare the evolution of retinopathy and nephropathy against placebo.

Design: Stage III clinical trial to evaluate efficacy and safety in a new indication of a medicine already on the market, parallel in two branches, randomised, triple-blind, and controlled with placebo.

Setting: Health care centres in Mallorca, Spain.

Participants: 42 patients per branch, over 18, with type-1 or 2 DM of over 3 years evolution, and one or more first or second-degree ulcers on the Wagner scale, distal to the knee, that did not heal in three months of health care. Randomised allocation in blocks of four.Interventions. The experimental drug was bemiparin (heparin of low molecular weight), injected subcutaneously at 3500 IU/day for the first 10 days and 2500 IU/day up to 90 days. As control, physiological serum was injected sub-cutaneously in a similar volume for masking.

Main measurements: An "effect"was defined as a reduction of at least 50% in its surface area and/or a favourable evolution in status to a degree between the control at the start of treatment and at three months. Other measurements included proteinuria, retinography and quality of life (SF-36). Analysis of efficacy through principle of intention to treat.