Actively Recruiting
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
Led by Applied Biologics, LLC · Updated on 2026-02-11
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Applied Biologics, LLC
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a single-layer amniotic membrane called XPURT combined with standard care compared to standard care alone in treating nonhealing pressure ulcers. This multicenter, prospective clinical trial aims to better understand how this treatment approach may help wounds that have not healed over time, involving up to 100 participants from multiple providers. Participants receive weekly treatments, either standard care alone or standard care plus XPURT, for up to 20 weeks or until their ulcer fully closes. The standard care includes cleaning, debridement, moisture balance, off-loading, and reduction of bacterial burden. Weekly evaluations of the ulcers are conducted to monitor progress, and dressing changes happen once or twice a week depending on the study arm. During the study, participants attend weekly visits for wound assessment and treatment. Researchers measure wound closure, healing time, wound area reduction, pain levels, quality of life, adverse events, and product usage. The study continues until the ulcer closes or 20 weeks have passed, with confirmation of closure two weeks after it is first observed. Safety and healing progress are closely monitored throughout the trial.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older
- Willing to attend weekly study visits
- Able and willing to participate in informed consent
- Have a full thickness pressure ulcer stage 3 or 4 without exposed bone, lasting at least one month, located on the trunk (sacral, trochanteric, or ischial)
- Target ulcer surface area between 2 cm2 and 100 cm2 measured after debridement
- Adequate off-loading of the ulcer
You will not qualify if you...
- Life expectancy less than 3 months
- Target ulcer is not a pressure ulcer
- Target ulcer is infected, requires systemic antibiotics, or has cellulitis
- Target ulcer exposes tendon or bone
- Presence of undermining or tunnelling at the wound edge
- Evidence of osteomyelitis complicating the ulcer
- Receiving immunosuppressants or cytotoxic chemotherapy or medications interfering with wound healing
- Applied topical steroids to the ulcer within one month before screening
- HbA1c greater than or equal to 12% within 3 months for diabetics
- Ulcer size reduced by more than 20% in the two weeks before screening
- Ulcer size decreased by 25% or more during the two-week screening phase
- Pregnant women or those planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participated in a clinical trial with investigational product within 30 days
- Medical or psychological condition interfering with assessments
- Treated with hyperbaric oxygen therapy or similar products within 30 days
- Malnutrition indicator score less than 17
- Known or suspected sensitivity to glutaraldehyde solutions
Research Team
B
Bennett Sarver
T
Thomas Serena, MD
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