Study for Non-Healing Diabetic Foot Ulcers
This study is looking at how well a treatment called XWRAP, a placental-based allograft (a special type of tissue graft), works for people with diabetic foot ulcers that haven't healed. It compares XWRAP plus standard care to standard care alone. You might be able to join if you are at least 18 years old, have type 1 or 2 diabetes, and have a non-healing foot ulcer. The study will measure how many ulcers close completely within 1 to 12 weeks. The study is currently unclear about its recruitment status and plans to enroll 60 people.
- Study design
- This is a controlled clinical trial, meaning some participants will receive the study treatment and others will receive standard care. It is designed as a "rescue" study, where patients who didn't heal in a previous study might receive XWRAP.
- What's involved
- You would receive XWRAP application and standard of care for up to 12 weeks. You must also agree to use a prescribed offloading method (a way to reduce pressure on your foot).
- Compensation
- Not stated in the trial record.
- Follow-up
- The main goal of the study is measured between 1 and 12 weeks, which suggests follow-up during this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07159282
A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers
Recruiting
PHASE4Ages 18+InterventionalTreatmentApplied Biologics, LLC
~60 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:XWRAP
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound Closure
Measured over 1-12 Weeks
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Wound Closure1-12 Weeks
The percentage of target ulcers achieving complete wound closure in 12 weeks.