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

Phase 1

Completed

• Conditions: Diabetes; Venous Stasis Ulcers; Chronic Wounds

• Registration Number: NCT00425178
• Lead Sponsor: CardioVascular BioTherapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2005-09-02
• Primary Completion: 2006-09-02
• Study Completion: 2006-12-01
• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Pharmacokinetics

Secondary Outcome Measures

Name	Time	Method
Wound improvement

Trial Locations

Locations (1)

Warren General Hospital; 🇺🇸 Warren, Pennsylvania, United States