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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425178

Enrollment

Registered

2007-01-22

Start date

2005-09-02

Completion date

2006-12-01

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Wounds, Diabetes, Venous Stasis Ulcers

Keywords

Chronic wounds, Diabetes, Ulcers, Arterial bypass, Angioplasty, Diabetic ulcers

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.

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.

Interventions

DRUGFGF-1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Safety	—
Pharmacokinetics	—

Secondary

Measure	Time frame
Wound improvement	—

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORThomas E Serena, MD

Warren General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026