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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-02

Study Completion Date

2006-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of Topical Human FGF-1 for Wound Healing

NCT00916292

Diabetic Foot Ulcers

UNKNOWN PHASE1

Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers

NCT05661474

Diabetic Foot

COMPLETED PHASE4

Effect of rhGM-CSF on the Healing of Venous Leg Ulcers

NCT04823962

Venous Leg Ulcer

UNKNOWN PHASE2

Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers

NCT00740922

Platelet-Derived Growth Factor Diabetic Foot Neoplasms

COMPLETED

A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers

NCT00351767

Foot Ulcer, Diabetic

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Wounds Diabetes Venous Stasis Ulcers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FGF-1

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No