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New amnion grafts aim to heal Hard-to-Close wounds

NCT ID NCT07046767

Disease control Sponsor: Capsicure, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a special tri-layer amnion graft or a single-layer amnion graft can help heal diabetic foot ulcers and venous leg ulcers that have not improved with standard care. About 165 adults with wounds between 2 and 25 cm² that have been open for over 4 weeks will receive one of the grafts. The main goal is to see if the wounds close completely within 12 weeks.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 165 people

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

Started

Oct 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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. Male or female 18 years of age and older 2. 2\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks 3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2 4. If the subject has more than one eligible wound the largest wound will be selected (the index wound) 5. Subject is able and willing to follow the protocol requirements 6. Subject has signed informed consent Exclusion Criteria: 1. Inability to adhere to the study protocol or study visit schedule 2. Pregnancy 3. Child-bearing potential without appropriate contraception 4. Lactation 5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit. 6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment) 7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety 8. Known contraindications to the use of amniotic tissue grafts 9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics

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Conditions

The condition(s) this trial relates to.

Diabetic Foot Foot Injuries injury 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) Venous leg ulcer Wound, foot

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • FOMAT Medical Research

    RECRUITING

    Oxnard, California, 93030, United States

  • Hope Vascular and Podiatry

    RECRUITING

    Houston, Texas, 77054, United States

  • Indiana University Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Jevlos Health, Inc

    RECRUITING

    Syosset, New York, 11791, United States

  • Nova Medical Services - Research Division LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • Solutions Medical Research

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • St. Louis Foot and Ankle, LLC

    RECRUITING

    St Louis, Missouri, 63128, United States

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