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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425178
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : January 8, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Wounds Diabetes Venous Stasis Ulcers Drug: FGF-1 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2005

Primary Outcome Measures :
  1. Safety
  2. Pharmacokinetics

Secondary Outcome Measures :
  1. Wound improvement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425178

United States, Pennsylvania
Warren General Hospital
Warren, Pennsylvania, United States, 16365
Sponsors and Collaborators
CardioVascular BioTherapeutics, Inc.
Principal Investigator: Thomas E Serena, MD Warren General Hospital Identifier: NCT00425178     History of Changes
Other Study ID Numbers: CVBT-W2005-01
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: November 2007

Keywords provided by CardioVascular BioTherapeutics, Inc.:
Chronic wounds
Arterial bypass
Diabetic ulcers

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Embolism and Thrombosis
Varicose Veins
Leg Ulcer
Skin Ulcer
Skin Diseases