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
111 weeks
Total Duration
On this page
Sponsors
A
Applied Biologics, LLC
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
CONDITIONS
Official 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 old or older
- Agree to attend weekly study visits as required
- Willing and able 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 after debridement
- Adequate off-loading of the ulcer
You will not qualify if you...
- Life expectancy less than 3 months
- Ulcer is not a pressure ulcer
- Ulcer is infected, requires systemic antibiotics, or has surrounding cellulitis
- Ulcer exposes tendon or bone
- Presence of undermining or tunneling at wound edge
- Evidence of osteomyelitis affecting the ulcer
- Receiving immunosuppressants, systemic corticosteroids over 10 mg prednisone per day, cytotoxic chemotherapy, or medications interfering with healing
- Applied topical steroids to the ulcer within 1 month prior to screening
- Glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months (for diabetics)
- Ulcer size reduced by more than 20% in the 2 weeks before screening
- Ulcer size reduced by 25% or more during the 2-week screening phase with standard care
- Pregnant or considering pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational treatment trial within 30 days
- Medical or psychological conditions interfering with study assessments
- Treated with hyperbaric oxygen therapy or similar matrix products within 30 days prior to screening
- Malnutrition indicator score below 17 on Mini Nutritional Assessment
- Known or suspected sensitivity to glutaraldehyde solutions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Serena Group- Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Bennett Sarver
CONTACT
T
Thomas Serena, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here