Actively Recruiting
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Led by Tiger Biosciences, LLC. · Updated on 2025-02-13
340
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
T
Tiger Biosciences, LLC.
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
CONDITIONS
Official Title
Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 21 years or older.
- Must have type 1 or type 2 diabetes (for diabetic foot ulcer group).
- Must have a target ulcer between 1.0 and 20.0 cm2 after debridement.
- Ulcer must have been present for at least 4 weeks and no more than 52 weeks under standard care.
- Foot ulcers must have at least 50% of the ulcer below the malleolus.
- Ulcers must be Wagner grade 1 or 2, extending through dermis or subcutaneous tissue, possibly involving muscle below medial malleolus.
- Affected limb must have adequate blood flow confirmed by vascular assessment within 3 months (ABI 0.7-1.3, TBI 60.6, TCOM 60 40 mmHg, or biphasic PVR).
- If multiple ulcers exist, they must be separated by at least 2 cm post-debridement.
- Plantar ulcers must be offloaded at least 14 days before enrollment.
- Must consent to using prescribed offloading method during the study.
- Must agree to weekly study visits.
- Must be willing and able to participate in the informed consent process.
- For venous leg ulcer group: no visible signs of healing (less than 40% wound size reduction in last 4 weeks).
You will not qualify if you...
- Life expectancy less than 6 months.
- Ulcer not caused by diabetes (for diabetic foot ulcers).
- Ulcer infected or requiring systemic antibiotics, or cellulitis present.
- Ulcer exposes tendon or bone.
- Evidence of osteomyelitis in the ulcer.
- Receiving immunosuppressants (including corticosteroids >10 mg prednisone/day), cytotoxic chemotherapy, or medications interfering with wound healing.
- Applied topical steroids to ulcer within 1 month prior to screening.
- Previous partial amputation causing deformity impeding offloading.
- HbA1c 12% or higher within 3 months before screening.
- Ulcer size reduced more than 20% in 2 weeks prior to screening or during 2-week screening phase.
- Acute or inactive Charcot foot impeding offloading.
- Pregnant or planning pregnancy within 6 months.
- End stage renal disease requiring dialysis.
- Participation in investigational product trial within last 30 days.
- Medical or psychological condition interfering with study assessments.
- Received hyperbaric oxygen therapy or CAMP treatment within 30 days prior to screening.
- Malnutrition score below 17 on Mini Nutritional Assessment.
- Wound with active or latent infection.
- Disorder creating unacceptable risk for post-operative complications.
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
M
Madison Dunn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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