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Amniotic tissue grafts aim to heal chronic wounds faster

NCT ID NCT07223892

Disease control Sponsor: Bardia Anvar 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial will test whether a graft made from donated amniotic tissue can help heal chronic wounds like diabetic foot ulcers and venous leg ulcers better than standard care. About 600 adults with wounds that haven't healed in 4 weeks will take part. The study will measure how many wounds close completely and how quickly.

What this could mean

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

Active substance
amniotic tissue graft
What this could lead to
If it works, this could provide a new treatment option that helps chronic wounds heal faster and more completely, reducing pain and healthcare costs.
What could go wrong
This is a large Phase 3 trial, but it hasn't started yet. The treatment may not work better than standard care, and there is a risk of infection or rejection of the graft.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

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 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: * Facilities and centers with the capacity to follow strict treatment and care guidelines for patients. * Adults aged 18 years or older. * Presence of a chronic wound (defined as a wound that has not shown significant improvement in 4 weeks) of any of the following etiologies: Diabetic foot ulcers, Venous leg ulcers, Arterial ulcers, Pressure ulcers, Burns, Trauma, Surgical * Wound size greater than 1 cm² * Ability to provide informed consent Exclusion Criteria: * Presence of active osteomyelitis * Untreated malignancy in the wound area * Known allergy to components of ATPs * Pregnant or breastfeeding women * Patients receiving immunosuppressive therapy * Patients with a life expectancy of less than 12 weeks

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Conditions

The condition(s) this trial relates to.

burn chronic ulcer of skin decubitus ulcer Diabetic Foot injury Surgical Wound ulcer of lower limbs

As listed by the trial registrant

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

Arterial ulcers Burn wounds Chronic wounds Diabetic foot ulcers (DFUS) Pressure ulcers Surgical wounds Trauma wounds Venous leg ulcers (VLUS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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