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.
| NCT ID | NCT07665268 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sequence LifeScience, Inc. |
| Condition | Skin Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2028-01-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,000 participants in total. It began in 2026-01-28 with a primary completion date of 2028-01-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
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 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.
Contact & Investigator
Thomas Serena, MD
PRINCIPAL INVESTIGATOR
Serena Group
Frequently Asked Questions
Who can join the NCT07665268 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07665268 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07665268 currently recruiting?
Yes, NCT07665268 is actively recruiting participants. Contact the research team at info@serenagroups.com for enrollment information.
Where is the NCT07665268 trial being conducted?
This trial is being conducted at North Royalton, United States.
Who is sponsoring the NCT07665268 clinical trial?
NCT07665268 is sponsored by Sequence LifeScience, Inc.. The principal investigator is Thomas Serena, MD at Serena Group. The trial plans to enroll 2,000 participants.