Placental patch could speed healing of stubborn diabetic foot sores
NCT ID NCT07159282
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a special graft made from donated placental tissue, called XWRAP, can help heal diabetic foot ulcers that won't close with standard care alone. About 60 adults with type 1 or type 2 diabetes will receive either the graft plus standard wound care or standard care alone for up to 12 weeks. The main goal is to see if more ulcers close completely with the graft.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- placental-based allograft (XWRAP)
- What this could lead to
- If it works, this could offer a new option to help heal stubborn diabetic foot ulcers faster and reduce the risk of infection or amputation.
- What could go wrong
- This is a small Phase 4 trial with only 60 participants, so results may not apply to everyone. The graft may not improve healing over standard care alone, and there is a risk of infection or allergic reaction.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * The potential subject must agree to attend the weekly study visits required by the protocol. * The potential subject must be willing and able to participate in the informed consent process. * The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint. Exclusion Criteria: * The potential subject is known to have a life expectancy of \< 6 months. * The potential subject's target ulcer is not secondary to diabetes. * The target ulcer is infected or there is cellulitis in the surrounding skin. * The target ulcer exposes tendon or bone. * There is evidence of osteomyelitis complicating the target ulcer. * There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. * The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics). * The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. * The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer. * The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. * The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer. * The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months. * The potential subject has end stage renal disease requiring dialysis. * The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. * The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. * The potential subject did not participate in the CAMPX trial. * The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm. * The potential subject participated in the CAMPX trial and achieved complete closure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Royal Research
RECRUITINGHollywood, Florida, 33024, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New wound dressing put to the test against diabetic foot ulcers
- Silver and sound: can ultrasound push nanoparticles into diabetic wounds?
- Zapping a leg nerve: can a wearable device help stubborn ulcers heal?
- Wound dressings that trap microbes: scientists test a Drug-Free approach
- Can a traditional herbal mix save limbs from diabetic ulcers?