A 6 MONTH, PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FRAGMIN IN THE TREATMENT OF CHRONIC NEUROISCHAEMIC FO...

Update Il y a 4 ans
Reference: EUCTR2007-005784-10

A 6 MONTH, PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FRAGMIN IN THE TREATMENT OF CHRONIC NEUROISCHAEMIC FOOT ULCERS IN DIABETIC PATIENTS

Woman and Man

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Extract

Evaluate the effect of dalteparin compared to placebo on the healing of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy, as determined by the number of patients who have ≥50% reduction in ulcer surface area including intact skin healing after a maximum of 6 months of treatment.


Inclusion criteria

  • Diabetic Foot Ulcer