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

This study has been completed.

Sponsored by:	CardioVascular BioTherapeutics, Inc.
Information provided by:	CardioVascular BioTherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00425178

Purpose

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	Intervention	Phase
Chronic Wounds Diabetes Venous Stasis Ulcers	Drug: FGF-1	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by CardioVascular BioTherapeutics, Inc.:

Primary Outcome Measures:

Safety
Pharmacokinetics

Secondary Outcome Measures:

Wound improvement

Enrollment:	8
Study Start Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425178

Locations

United States, Pennsylvania
Warren General Hospital
Warren, Pennsylvania, United States, 16365

Sponsors and Collaborators

CardioVascular BioTherapeutics, Inc.

Investigators

Principal Investigator:

Thomas E Serena, MD

Warren General Hospital

More Information

Study ID Numbers:	CVBT-W2005-01
Study First Received:	January 18, 2007
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00425178
Health Authority:	United States: Food and Drug Administration

Keywords provided by CardioVascular BioTherapeutics, Inc.:

Chronic wounds
Diabetes
Ulcers

Arterial bypass
Angioplasty
Diabetic ulcers

Study placed in the following topic categories:

Peripheral Vascular Diseases
Skin Diseases
Ulcer
Diabetes Mellitus
Vascular Diseases
Postthrombotic Syndrome
Thrombosis
Varicose Ulcer
Embolism and Thrombosis

Varicose Veins
Embolism
Phlebitis
Venous Insufficiency
Venous Thrombosis
Skin Ulcer
Postphlebitic Syndrome
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009