NCT00425178

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

A Phase 1, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Patients With Diabetic or Venous Stasis Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: CardioVascular BioTherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Wounds
• Diabetes
• Venous Stasis Ulcers

Interventions

Type	Name	Description
DRUG	FGF-1

Timeline

• Start date: 2005-09-02
• Primary completion: 2006-09-02
• Completion: 2006-12-01
• First posted: 2007-01-22
• Last updated: 2019-11-01

Locations

1 site across 1 country: United States