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

This study has been completed.
Sponsor:
Information provided by:
CardioVascular BioTherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00425178
First received: January 18, 2007
Last updated: January 7, 2008
Last verified: November 2007
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 19, 2014