CompletedNot Applicable

A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds.

United States500 participantsStarted 2025-04-23

Plain-language summary

This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
. 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.
. Subjects should have been treated from January 2022 to present day.

Exclusion criteria

. Subjects that did not have a wound closure verification appointment.
. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of wound closure by or on week 16

Timeframe: 16 weeks

Trial details

NCT IDNCT07078968

SponsorBioLab Holdings

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Venous Leg Ulcer (VLU) trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
. 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.
. Subjects should have been treated from January 2022 to present day.

Exclusion criteria

. Subjects that did not have a wound closure verification appointment.
. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.