XPURT and Standard Care for Nonhealing Pressure Ulcers
This study is looking at a new way to help nonhealing pressure ulcers (bedsores) get better. It compares a single-layer amniotic membrane called XPURT, along with standard care, to just standard care alone. Standard care involves cleaning, removing dead tissue (debridement), keeping the ulcer moist, and relieving pressure. You could be eligible if you are at least 18 years old and have a full-thickness pressure ulcer (stage 3 or 4) without exposed bone. The main goal is to see if the ulcers close completely within 1 to 22 weeks. This study plans to include 100 participants, but its current status is unclear.
- Study design
- This is a multicenter, controlled clinical study involving 100 participants. It compares two groups: one receiving XPURT plus standard care, and another receiving only standard care.
- What's involved
- Participants will have weekly study visits for up to 20 weeks, or until their ulcer closes. During these visits, they will receive treatment and have their ulcer evaluated.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, complete closure, is measured at 1-22 weeks, with confirmation 2 weeks later.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07126886
A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers
Recruiting
PHASE4Ages 18+InterventionalTreatmentApplied Biologics, LLC
~100 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Standard of CareXPURT + SOC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Closure
Measured over 1-22 Weeks
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
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 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 a full thickness pressure ulcer NPIAP stage 3 through stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post debridement with the imaging device.
The potential subject has adequate off-loading of the ulcer.
Exclusion
The potential subject is known to have a life expectancy of \< 3 months.
The potential subject's target ulcer is not a pressure ulcer.
The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
There is undermining at the wound edge or tunnelling.
There is evidence of osteomyelitis complicating the target ulcer.
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 has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit(For diabetics only).
The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
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.
The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.
The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.
What this trial measures
- Complete Closure1-22 Weeks
The percentage of target ulcers achieving complete wound closure in 20 weeks.