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

Launched by APPLIED BIOLOGICS, LLC · Aug 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for pressure ulcers, which are wounds that develop from prolonged pressure on the skin, often in people who spend a lot of time in bed or a wheelchair. The trial is testing whether using a special single-layer amniotic membrane (a natural tissue that can help healing) along with standard wound care works better than standard care alone for pressure ulcers that have not been healing for at least a month.

Adults aged 18 and older with a certain level of pressure ulcers on their lower back or hips that are at least 2 cm² in size may be eligible to join. Participants will need to attend weekly visits to the clinic and agree to the study procedures. People with infections, exposed bone or tendon, or certain health conditions may not qualify. Those who join will receive either the new amniotic membrane treatment plus standard care or just the usual care, and doctors will regularly check how well their wounds heal. This study aims to find better ways to help stubborn pressure ulcers heal and improve quality of life for those affected.

Gender

ALL

Eligibility criteria

• 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.