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Amniotic membrane wraps show promise for stubborn wounds

NCT ID NCT07078968

Disease control Sponsor: BioLab Holdings 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at whether special wraps made from human amniotic membrane can help heal chronic wounds like diabetic foot ulcers, venous leg ulcers, and pressure ulcers. Researchers reviewed data from 500 patients who either received the membrane wraps or standard wound care. The goal was to see if the wraps led to faster and more complete wound closure within 16 weeks.

What this could mean

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

Active substance
Human amniotic membrane wraps (Tri-Membrane Wrap, Membrane Wrap, Membrane Wrap-Hydro)
What this could lead to
If these wraps work well, they could offer a better way to heal stubborn chronic wounds, reducing infection risk and improving quality of life.
What could go wrong
This is a retrospective study, not a controlled trial, so results may be less reliable. The wraps are compared to standard care, but differences in patient care could skew findings.

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.

Participants

500 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

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.

Who is studied

Subjects with difficult to heal partial- or full-thickness diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure ulcers (PU), and post-operative wounds defined as an ulcer that has not healed with conventional therapy for ≥ 4 weeks.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds 2. Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only. 3. Subjects should have been treated from January 2022 to present day. Exclusion Criteria: 1. Subjects that did not have a wound closure verification appointment. 2. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer Diabetic Foot ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Diabetic foot ulcer (DFU) Pressure ulcer (PU) Venous leg ulcer (VLU)

Contacts and locations

Locations

  • Athena Specialty Group

    Phoenix, Arizona, 85048, United States

  • Houston Foot Dr

    Houston, Texas, 77095, United States

  • Houston Foot and Ankle Care

    Houston, Texas, 77027, United States

  • Revive Advanced Wound Care

    Toms River, New Jersey, 08755, United States

More trials for these conditions

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