FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CardioVascular BioTherapeutics, Inc.
• Collaborator: Warren General Hospital

Criteria

Eligibility Criteria:

• Informed consent

• 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

• Compliance with wound care regimen