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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Venous Stasis Ulcers; Chronic Wounds
• Intervention / Treatment: Drug: FGF-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
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Pharmacokinetics

Secondary Outcome Measures

Outcome Measure
Wound improvement

Collaborators and Investigators

• Sponsor: Venturis Therapeutics, Inc.
• Collaborators: Warren General Hospital
• Investigators: Principal Investigator: Thomas E Serena, MD, Warren General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2005
• Primary Completion (Actual): September 2, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: January 18, 2007
• First Submitted That Met QC Criteria: January 18, 2007
• First Posted (Estimated): January 22, 2007

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Angioplasty; Ulcers; Chronic wounds; Arterial bypass; Diabetic ulcers
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Ulcer; Varicose Ulcer; Diabetes Mellitus; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Intercellular Signaling Peptides and Proteins; Fibroblast Growth Factors; Fibroblast Growth Factor 1
• Other Study ID Numbers: CVBT-W2005-01