FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers
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FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and wound improvement.
Condition or disease
Chronic WoundsDiabetesVenous Stasis Ulcers
Patients meeting eligibility criteria will be randomized to receive topical administration of either FGF-1 or placebo. Patients will be evaluated at days 1 and 7, post-treatment for safety, pharmacokinetics, and wound healing.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female patients post-menopausal, sterilized, or on adequate birth control
Full-thickness lower extremity diabetic or venous statis ulcers of specific target size and of at least 8 weeks but no more than 1 year duration
Target ulcer freshly debrided at screening or within two weeks prior to screening
Adequate blood supply defined by transcutaneous oxygen pressure > 20 mmHG and ABI greater than or equal to 0.4
Compliance with non-weight bearing regimen in diabetic patients