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Could a growth factor patch fix eardrums without surgery?

NCT ID NCT02307916

Disease control Sponsor: D. Bradley Welling, MD, PhD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested whether a gel containing human fibroblast growth factor-2 (FGF-2) can safely close chronic holes in the eardrum. Fifty-seven adults with dry eardrum perforations lasting over 3 months received either the FGF-2 gel or a placebo saline patch, with up to three treatments. The main goal was to see if the hole closed completely, with hearing tests as secondary measures.

What this could mean

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

Active substance
Fibroblast Growth Factor-2 (FGF-2) applied on a gelatin foam patch with fibrin glue
What this could lead to
If it works, this could provide a simple, non-surgical way to close chronic eardrum holes, potentially restoring hearing and reducing infection risk.
What could go wrong
This is a small Phase 2 trial with only 57 people, so results may not apply to everyone. The treatment may not close the hole, and risks like infection or incomplete healing exist.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Start date

Oct 2016

Finished

Mar 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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.

Inclusion Criteria: 1. Dry tympanic membrane perforation of greater than 3 months duration 2. If female, post-menopausal or sterile, or if she is of child-bearing potential, must have a negative beta-human chorionic gonadotropin (HCG) test and must be using an adequate form of birth control such as birth control pills, birth control implants, intrauterine devices (IUDs), diaphragms or condoms. Exclusion Criteria: The presence of any of the following excludes a subject from study enrollment: * Active otitis media or chronic otorrhea from the middle ear * Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy * Subjects who, at study entry, are taking systemic antibiotics * Subjects who are immunosuppressed * Subjects experiencing bacterial or viral infection or who may otherwise be febrile * Life expectancy of less than 1 year * Active alcohol or drug abuse within 6 months prior to study entry * Significant medical condition that could prevent full participation in the procedures required for the study (See body of protocol for full list of exclusions) * Known or suspected allergies to any components used in the study * Subjects who have cholesteatoma mass in the tympanic cavity * Subjects whose total perforation cannot be seen by an endoscope * Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher) * Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility

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Conditions

The condition(s) this trial relates to.

Tympanic Membrane Perforation

As listed by the trial registrant

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

Tympanic membrane perforation

Contacts and locations

Locations

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

  • Wilford Hall, Lackland Airforce Base

    Lackland City, Texas, 78236, United States

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