Single-layer amniotic membrane (XPURT) plus standard care for chronic pressure ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, controlled clinical study enrolling 100 adults with chronic full-thickness pressure ulcers (NPIAP stage 3–4) across up to 30 providers. Participants receive weekly applications of XPURT plus standard of care (SOC) or matched-control SOC and are evaluated weekly using wound imaging after debridement. Treatment continues for up to 20 weeks or until complete ulcer closure is documented and confirmed two weeks later. One optional weekly visit is allowed for dressing changes in either arm while investigators monitor healing and adverse events throughout the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Serena Group- Monroeville
  Monroeville, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Bennett Sarver
• Email: info@serenagroups.com
• Phone: 1-833-865-6300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.