Actively Recruiting
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
Led by Tiger Biosciences, LLC. · Updated on 2025-06-05
500
Participants Needed
1
Research Sites
101 weeks
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 purpose of this study it to evaluate 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.
CONDITIONS
Official 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...
- Be 18 years of age or older
- Agree to attend weekly study visits
- Be willing and able to participate in informed consent
- Have a full-thickness pressure ulcer stage 3 or 4 on the trunk (sacral, trochanteric, or ischial) lasting at least one month without exposed tendon or bone
- Have a target ulcer with surface area between 2 cm2 and 100 cm2 measured after debridement
- Have adequate off-loading of the ulcer
You will not qualify if you...
- Have a life expectancy of less than 3 months
- Have a target ulcer that is not a pressure ulcer
- Have an infected target ulcer, require systemic antibiotics, or have surrounding skin cellulitis
- Have a target ulcer exposing tendon or bone
- Have a target ulcer with undermining or tunneling
- Have osteomyelitis complicating the target ulcer
- Be receiving immunosuppressants (including systemic corticosteroids over 10 mg prednisone daily) or cytotoxic chemotherapy, or medications interfering with wound healing
- Have applied topical steroids to the ulcer surface within 1 month of screening
- Have glycated hemoglobin (HbA1c) ≥12% within 3 months before screening
- Have had ulcer surface area reduce by more than 20% in the 2 weeks before screening
- Have ulcer surface area decrease by 25% or more during the 2-week screening phase
- Be pregnant or considering pregnancy within 6 months
- Have end stage renal disease requiring dialysis
- Have medical or psychological conditions interfering with study assessments
- Have had hyperbaric oxygen therapy or CAMP treatments in the 30 days before screening
- Have a malnutrition score less than 17 on the Mini Nutritional Assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Serena Group
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
A
Arshdeep Kaur, MS
CONTACT
K
Khristina Harrel
CONTACT
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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