Actively Recruiting
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
Led by Tiger Biosciences, LLC. · Updated on 2025-06-05
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tiger Biosciences, LLC.
Lead Sponsor
E
ExtremityCare, LLC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the management of nonhealing pressure ulcers using several cellular, acellular, and matrix-like products (CAMPs) combined with standard of care compared to matched standard of care controls. The goal is to determine differences in the rate of complete closure of pressure ulcers over 20 weeks using a modified platform trial design. Initially, two CAMPs will be studied, with the option to add more during the trial. Participants will be randomly assigned to one of three groups: weekly applications of ACApatch™ plus standard of care, weekly applications of caregraFT™ plus standard of care, or standard of care alone. Standard of care includes cleaning, debridement, and ulcer moisture balance. Treatments continue weekly until ulcer closure or for a maximum of 20 weeks. During the study, participants will attend weekly visits for treatment and ulcer assessment. Researchers will measure complete wound closure, time to closure, percentage area reduction, quality of life, and adverse events over the 20-week period. The study is designed to monitor healing progress and safety throughout the treatment duration.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years old
- Must agree to attend weekly study visits as required
- Must be willing and able to participate in informed consent
- Must have a full-thickness pressure ulcer stage 3 or 4 on the trunk (sacral, trochanteric, or ischial) lasting at least one month
- Must have a target ulcer with a surface area between 2 cm² and 100 cm² after debridement
- Must have adequate off-loading of the ulcer
You will not qualify if you...
- Life expectancy less than 3 months
- Target ulcer is not a pressure ulcer
- Ulcer is infected, requires systemic antibiotics, or has surrounding cellulitis
- Ulcer exposes tendon or bone
- Ulcer has undermining or tunneling
- Evidence of osteomyelitis affecting the ulcer
- Receiving immunosuppressants above specified doses, cytotoxic chemotherapy, or medications interfering with wound healing
- Applied topical steroids to the ulcer within one month prior to screening
- Glycated hemoglobin (HbA1c) is 12% or higher within 3 months of screening
- Ulcer surface area reduced more than 20% in 2 weeks before screening
- Ulcer surface area reduced 25% or more during the 2-week screening phase with standard care
- Pregnant or planning pregnancy within 6 months
- Has end stage renal disease requiring dialysis
- Medical or psychological condition interfering with study assessments
- Received hyperbaric oxygen therapy or CAMP in 30 days before screening
- Malnutrition indicator score below 17 on Mini Nutritional Assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 20 weeks or until ulcer closure
Participants receive weekly applications of either ACApatch™, caregraFT™, or standard of care for nonhealing pressure ulcers until ulcer closure or a maximum of 20 weeks.
Weekly visits for up to 20 weeks
Trial Site Locations
Total: 1 location
1
Serena Group
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
A
Arshdeep Kaur, MS
K
Khristina Harrel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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