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Can a growth factor protein heal stubborn leg ulcers?

NCT ID NCT00425178

Disease control Sponsor: Venturis Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether a single topical application of FGF-1, a protein that helps cells grow, is safe for people with diabetic or venous stasis ulcers. The study enrolls a small group of adults with full-thickness leg ulcers that have lasted at least 8 weeks. Researchers will monitor safety, how the body processes the drug, and any signs of wound improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FGF-1 (human fibroblast growth factor-1), a protein applied topically to the wound
What this could lead to
If safe and effective, FGF-1 could become a new topical treatment to help heal chronic diabetic or venous ulcers.
What could go wrong
This is a very early, small pilot study focused on safety, not proof of healing. The treatment may not improve wounds or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Sep 2005

Finished

Dec 2006

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus ulcer disease Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic wounds Diabetes Venous stasis ulcers

Contacts and locations

Locations

  • Warren General Hospital

    Warren, Pennsylvania, 16365, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.