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Can a placental patch help heal stubborn diabetic foot ulcers?

NCT ID NCT06616844

Disease control Sponsor: ConvaTec Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether adding a patch made from pig placental tissue to standard wound care helps diabetic foot ulcers close faster than standard care alone. The study involves about 235 adults with diabetes who have a hard-to-heal foot ulcer. Participants are randomly assigned to receive either the patch plus standard care or standard care only, and the main goal is to see if the patch increases the chance of complete wound closure within 12 weeks.

What this could mean

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

Active substance
A wound dressing made from porcine placental extracellular matrix (InnovaMatrix AC), applied weekly alongside standard wound care.
What this could lead to
If effective, this could offer a new option to help hard-to-heal diabetic foot ulcers close, potentially reducing the risk of infection and amputation.
What could go wrong
The trial is still in progress, and results may not show a clear benefit over standard care. There is also a risk of allergic reactions or infection at the wound site.

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 235 people

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

Started

Feb 2025

Expected to finish

Jan 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: 1. Subjects at least 21 years old. At least 50% of the enrolled population must be \> 65 years of age. 2. Known history of type 1 or type 2 diabetes. 3. The patient must have a target ulcer meeting the following characteristics: i. A diabetic ulcer that is either Wagner Grade 1 or Wagner Grade 2 . ii. Located on the anatomical foot; defined as a minimum of 50% of ulcer area extending distal to the medial malleolus. iii. The target ulcer must have been present for a minimum of 4 weeks and no longer than 52 weeks. iv. The target ulcer must display evidence of delayed wound healing, defined as less than 50% wound area reduction over the four weeks preceding randomization. v. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post-debridement. 4. If two or more diabetic foot ulcers with the same Wagner Grade are present, the Index ulcer must additionally be: i. the ulcer with the largest wound area; ii. ≥ 2cm distant from any other ulcer on the affected limb, post-debridement; iii. the only ulcer to be evaluated by the study (one patient, one wound). 5. Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days i. ABI ≥ 0.7 and ≤ 1.3; ii. TBI ≥ 0.6; iii. TCOM ≥ 40 mmHg; iv. PVR: biphasic. 6. BMI ≤45 7. Subject is willing to participate in all procedures and follow-up evaluations necessary to complete the study. 8. Subject has signed informed consent. Exclusion: 1. The potential subject is known to have a life expectancy of \<6 months. 2. Index Ulcers will be excluded if they meet any of the following criteria upon assessment: i. Index ulcer determined to be due to a condition other than diabetes ii. Active Charcot deformity OR major structural abnormalities of the foot iii. Known or suspected local skin malignancy to the index diabetic ulcer iv. Wound duration \>12 months without intermittent closure 3. The target ulcer exhibits 2 or more of the following signs or symptoms consistent with clinical infection: i. erythema that extends ≥ 0.5cm from wound edge ii. local increased warmth iii. purulent exudate iv. local swelling or induration v. local tenderness or pain 4. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator\'s exam or radiographic evidence. 5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent), radiation therapy, cytotoxic chemotherapy, or is taking medications that the Principal Investigator believes will interfere with wound healing (e.g., biologics). 6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. 7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. 8. The surface area of the target ulcer, as measured by digital planimetry or manual linear measurements (e.g. with a ruler), decreases by more than 25% in the 2 weeks prior to the initial screening visit ("historical" run-in period). 9. The surface area of the target ulcer, as measured by digital planimetry, decreases by more than 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC. 10. The potential subject is unable to adhere to therapeutic offloading, if required by anatomical location of target ulce. 11. Women who are pregnant or considering becoming pregnant within the next 6 months. 12. The potential subject has end stage renal disease requiring dialysis. 13. Participation in another clinical trial involving treatment with an investigational product within the previous 30 days. 14. A potential subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments. 15. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 16. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. 17. Potential subjects with a sensitivity or allergy to porcine materials or collagen will be excluded. 18. Potential subjects with religious or personal objection to use of porcine- or animal-derived materials will be excluded. 19. A subject with a disorder that would create unacceptable risk of treatment complications is excluded. 20. Subjects will be considered ineligible for enrolment if any of the following criteria are met: i. Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV. ii. In the past 6 months, having undergone a revascularization procedure aimed at increasing blood flow in the target limb OR any amputation affecting the target limb

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Conditions

The condition(s) this trial relates to.

ulcer disease

As listed by the trial registrant

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

Ulcer Wound heal

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Angel City Research

    RECRUITING

    Los Angeles, California, 90010, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Center for Clinical Research

    RECRUITING

    San Francisco, California, 94115, United States

  • Clemente Clinical Research

    RECRUITING

    Los Angeles, California, 90033, United States

  • Dinamo Research and Diagnostic Center

    RECRUITING

    Hialeah, Florida, 33015, United States

    Contact Email: •••••@•••••

  • First Excellence Research Group

    RECRUITING

    Doral, Florida, 33178, United States

  • ILD Research Center

    RECRUITING

    Vista, California, 92081, United States

  • Indiana Foot & Ankle

    COMPLETED

    Jasper, Indiana, 47456, United States

  • Innovative Medical Research of Texas

    RECRUITING

    Houston, Texas, 77065, United States

  • Lenus Research and Medical Group, LLC

    RECRUITING

    Sweetwater, Florida, 33172, United States

  • Limb Preservation Platform

    RECRUITING

    Fresno, California, 93710, United States

  • New Dawn Wellness and Medical Research Center

    RECRUITING

    Houston, Texas, 77082, United States

  • Northwell Health Comprehensive Wound Healing Center

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Sunshine Ankle and Foot Experts

    RECRUITING

    Orlando, Florida, 32828, United States

  • US-FAS

    TERMINATED

    Hagerstown, Maryland, 21742, United States

  • US-FAS

    RECRUITING

    Raleigh, North Carolina, 27609, United States

  • University of Florida Jacksonville

    TERMINATED

    Jacksonville, Florida, 32209, United States

  • University of Pittsburgh Medical Center (UMPC)

    RECRUITING

    McKeesport, Pennsylvania, 15132, United States

  • Valiance Clinical Research

    RECRUITING

    San Diego, California, 92117, United States

  • Valiance Clinical Research

    RECRUITING

    Tarzana, California, 91356, United States

  • White-Wilson Wound Care Center

    TERMINATED

    Fort Walton Beach, Florida, 32547, United States

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