Actively Recruiting
A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform Trial Evaluating Cellular, Acellular, and Matrix-like Products (CAMPs) Plus Standard of Care Versus Standard of Care Alone for Nonhealing Diabetic Foot and Venous Leg Ulcers
Led by Tiger Biosciences, LLC. · Updated on 2025-02-13
340
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tiger Biosciences, LLC.
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the management of nonhealing diabetic foot ulcers and venous leg ulcers by comparing several Cellular, Acellular, and Matrix-like Products (CAMPs) combined with standard care versus standard care alone. The study uses a randomized controlled modified multi-platform design to assess wound healing over 12 weeks. The goal is to determine if adding CAMPs to standard care improves the rate of complete ulcer closure in adults with these chronic wounds. Participants receive weekly applications of either ACApatch12, caregraFT12 (both derived from human placental tissue), or standard care alone. Standard care includes cleaning, debridement, moisture balance of the ulcer, and offloading. Treatments continue weekly until the ulcer closes or for a maximum of 12 weeks. Different study groups focus on diabetic foot ulcers or venous leg ulcers, each receiving one of the CAMPs plus standard care or standard care alone. During the study, participants attend weekly visits where wound closure progress is monitored. Assessments include measuring wound area, evaluating pain using a visual analogue scale, and tracking any adverse events. Researchers compare the proportion of participants who achieve complete wound closure between groups over the 12-week period. Participant safety and healing progress are closely observed throughout the trial, which lasts up to 12 weeks per individual.
CONDITIONS
Brief 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...
- Must be 21 years of age or older
- Diagnosis of type 1 or type 2 diabetes mellitus (for diabetic foot ulcer participants)
- Target ulcer with surface area between 1.0 cm2 and 20.0 cm2 measured after debridement
- Ulcer present for at least 4 weeks and no more than 52 weeks of standard of care before screening
- Ulcer located on the foot with at least 50% below the malleolus (for diabetic foot ulcer participants)
- Ulcer is Wagner grade 1 or 2, extending through dermis or subcutaneous tissue and possibly muscle below medial malleolus (for diabetic foot ulcer participants)
- Adequate limb perfusion confirmed by vascular assessment within 3 months
- If multiple ulcers, must be at least 2 cm apart post-debridement; largest ulcer designated target
- Offloading of plantar foot ulcers for at least 14 days prior to enrollment (for diabetic foot ulcer participants)
- Agreement to use prescribed offloading method during study
- Agreement to attend weekly study visits
- Willingness and ability to provide informed consent
- For venous leg ulcer participants: ulcer with less than 40% reduction in size in last 4 weeks and adequate perfusion
You will not qualify if you...
- Life expectancy less than 6 months
- Target ulcer not caused by diabetes (for diabetic foot ulcer participants)
- Infected ulcer requiring systemic antibiotics or cellulitis nearby
- Ulcer exposing tendon or bone
- Evidence of osteomyelitis at ulcer site
- Use of immunosuppressants or cytotoxic chemotherapy interfering with wound healing
- Topical steroids applied to ulcer within 1 month before screening
- Previous partial amputation causing deformity that prevents proper offloading (for diabetic foot ulcer participants)
- Glycated hemoglobin (HbA1c) equal to or greater than 12% within 3 months before screening
- Ulcer surface area reduced by more than 20% during 2 weeks before screening
- Ulcer surface area reduced by 20% or more during 2-week screening phase with standard care
- Acute or inactive Charcot foot impairing offloading (for diabetic foot ulcer participants)
- Pregnant women or those planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in an investigational product trial within 30 days
- Medical or psychological condition interfering with study assessments
- Hyperbaric oxygen therapy or CAMP treatment within 30 days before screening
- Malnutrition score less than 17 on Mini Nutritional Assessment
- Wound with active or latent infection
- Disorder creating unacceptable risk of post-operative complications
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 visit (in-person)
Duration - Up to 12 weeks or until ulcer closure
Participants receive weekly applications of the assigned product(s) plus Standard of Care or Standard of Care alone until ulcer closure or for a maximum of 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Serena Group
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
A
Arshdeep Kaur, MS
M
Madison Dunn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here