Multicenter test of several CAMP products plus standard care for nonhealing 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 platform trial comparing five CAMP products—Activate Matrix, AmnioDefend FT Matrix, Palisade Matrix, Sentry SL Matrix, and Shelter DM Matrix—each combined with standard of care, against matched standard-of-care controls for nonhealing pressure ulcers. Up to 2,000 adults with stage 3–4 full-thickness pressure ulcers are randomized to one of the five treatments or control and assessed weekly for up to 20 weeks or until complete wound closure. Treatments are applied weekly, with an optional additional visit for secondary dressing changes. The primary outcome is complete ulcer closure, confirmed at a follow-up visit two weeks later. The study is conducted across up to 25 investigational sites with up to 75 providers. Eligibility requires adults 18+, a confirmed nonhealing stage 3–4 pressure ulcer on trunk regions, specified ulcer size, and adequate off-loading.

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 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 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.
* 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.

Where it's running

• Amber Stormer
  North Royalton, Ohio, United States Recruiting

Study contacts

• Principal investigator: Thomas Serena, MD — Serena Group
• Study coordinator: Bennett Sarver
• Email: info@serenagroups.com
• Phone: 1-833-865-6300

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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.