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Completed

NCT Number: NCT00425178

FGF-1 for Topical Administration for the Treatment of 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.

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Key information

Conditions

Chronic Wounds Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Varicose Ulcer Varicose Veins Vascular Diseases Venous Stasis Ulcers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Warren General Hospital

Warren, Pennsylvania, 16365, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FGF-1

Drug

Primary outcomes

  1. Safety

  2. Pharmacokinetics

Secondary outcomes

  1. Wound improvement

Sponsors and collaborators

Lead sponsor

CardioVascular BioTherapeutics, Inc.

Industry

Collaborators

  • Warren General Hospital

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 22, 2007
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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