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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425178
• Other study ID #: CVBT-W2005-01
• Status: Completed
• Phase: Phase 1
• Start date: September 2, 2005
• Est. completion date: December 1, 2006

Study information

• Verified date: October 2019
• Source: CardioVascular BioTherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 1, 2006
• Est. primary completion date: September 2, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Wounds
• Diabetes
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcers

Intervention

Drug:
• FGF-1

Locations

Country	Name	City	State
United States	Warren General Hospital	Warren	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
CardioVascular BioTherapeutics, Inc.	Warren General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Pharmacokinetics
Secondary	Wound improvement