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Study for Non-Healing Pressure Ulcers

This study is looking for 2000 adults aged 18 or older with non-healing pressure ulcers (also called pressure sores or bedsores) that are full-thickness stage 3 or 4. It's testing five different products: Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix, Sentry™ SL Matrix, and Shelter™ DM Matrix. Each product is given weekly along with standard care. The goal is to see which treatment helps the ulcers close completely within 20 weeks. You would need to attend weekly study visits. The study is currently recruiting participants.

Study design
This is a multi-center, prospective, modified platform trial involving 2000 participants. Participants will be randomly assigned to receive one of five treatments plus standard care.
What's involved
You would receive weekly applications of one of the study treatments and standard of care for up to 20 weeks, or until your ulcer closes. You would also need to attend weekly study visits.
Compensation
Not stated in the trial record.
Follow-up
Ulcer closure is assessed weekly, and confirmed 2 weeks after initial closure, up to a maximum of 20 weeks.

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NCT07665268

Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.

Recruiting
PHASE4Ages 18+InterventionalTreatment
Sequence LifeScience, Inc.
~2,000 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Activate™ Matrix + SOCAmnioDefend™ FT Matrix + SOCPalisade™ DM Matrix + SOCSentry™ SL Matrix + SOCShelter™ DM Matrix + 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
Between Arm Difference for Complete Closure
Measured over 0-20 Weeks

Conditions

Skin Ulcer
Pressure Ulcer (PU)
Pressure Ulcer of Skin
Pressure Sore
Chronic Ulcer
Pressure Wound

Explore related trials

Pressure Sore

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Thomas Serena, MD · PRINCIPAL_INVESTIGATOR · Serena Group

Who to contact

Bennett Sarver
[email protected]
1-833-865-6300
Email the study team

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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 or stage 4 without exposed tendon or 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 100cm2 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.
The target ulcer has undermining or tunneling.
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.
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 × 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, 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 of \<17 as measured on the Mini Nutritional Assessment.
Known hemoglobin of \< 8 g/dL as this is an indicator of poor wound healing.

What this trial measures

  • Between Arm Difference for Complete Closure0-20 Weeks

    Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.