Cellular, acellular, and matrix wound products plus standard care for nonhealing stage 3–4 pressure ulcers

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrixlike Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

This study will try several cellular, acellular, and matrix-like wound products with standard care to see if adults with nonhealing stage 3–4 pressure ulcers heal more completely over 20 weeks than with standard care alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tiger Biosciences, LLC. (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Monroeville, Pennsylvania)
• Trial ID: NCT06999590 on ClinicalTrials.gov

What this trial studies

This phase 4 interventional platform trial compares multiple cellular, acellular, and matrix-like products (CAMPs) plus standard of care to matched standard-of-care controls over a 20-week treatment period. The modified platform design begins with two CAMPs (ACApatch™ and caregraFT™) and can add additional products over time, randomizing participants to CAMP+SOC arms or matched SOC controls. Eligible adults have full-thickness NPIAP stage 3 or 4 pressure ulcers on the trunk of at least one month and with a post-debridement area of 2–100 cm2, and must be able to attend weekly visits and maintain adequate off-loading. The main outcome is complete ulcer closure within 20 weeks compared between CAMP+SOC and matched SOC controls.

Who should consider this trial

Good fit: Adults 18 or older with a full-thickness (NPIAP stage 3 or 4) pressure ulcer on the sacral, trochanteric, or ischial area lasting at least one month and measuring 2–100 cm2 after debridement who can be adequately off-loaded and attend weekly visits.

Not a fit: Patients with non-pressure ulcers, infected ulcers requiring systemic antibiotics, exposed tendon or bone, life expectancy under three months, or who cannot off-load the ulcer or attend weekly visits are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, these products could increase complete closure rates and speed healing of chronic pressure ulcers, reducing complications and overall care burden.

How similar studies have performed: Related cellular and matrix wound therapies have shown benefit in some chronic wound and pressure ulcer studies, but results are mixed and platform-style comparisons are relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The potential subject must be at least 18 years of age or older.
2. The potential subject must agree to attend the weekly study visits required by the protocol.
3. The potential subject must be willing and able to participate in the informed consent process.
4. 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).
5. 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.
6. The potential subject has adequate off-loading of the ulcer.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of \< 3 months.
2. The potential subject's target ulcer is not a pressure ulcer.
3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. The target ulcer has undermining or tunneling.
6. There is evidence of osteomyelitis complicating the target ulcer.
7. 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).
8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
9. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
10. 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).
11. 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.
12. The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
13. The potential subject has end stage renal disease requiring dialysis.
14. The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
15. 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.
16. The potential subject has a malnutrition indicator score of \<17 as measured on the Mini Nutritional Assessment.

Where this trial is running

Monroeville, Pennsylvania

• Serena Group — Monroeville, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Serena, MD — Serena Group
• Study coordinator: Arshdeep Kaur, MS

Conditions Pressure Ulcer; Ulcer; Ulcer, Pressure; Pressure Injury