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

CardioVascular BioTherapeutics, Inc.8 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Wounds Diabetes Venous Stasis Ulcers

Interventions

FGF-1DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Warren General Hospital

Warren, Pennsylvania, United States

Outcomes

Primary Outcomes

Safety

Pharmacokinetics

Secondary Outcomes

Wound improvement

Data from ClinicalTrials.gov

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