Actively Recruiting
Trial Comparing Multiple Cellular and Matrix-like Products Plus Standard Care Versus Standard Care Alone for Diabetic Foot and Venous Leg Ulcers Using a Modified Multi-Platform Design
Led by Stability Biologics · Updated on 2025-01-20
324
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Stability Biologics
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different types of cellular, acellular, and matrix-like products (CAMPs) combined with standard care compared to standard care alone for healing nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, randomized controlled trial uses a modified multi-platform (Matriarch) design to compare these treatments and determine differences in ulcer closure over 12 weeks. The study aims to include multiple CAMPs per wound type and allows for adding more during the trial. Participants will receive weekly treatments starting at screening. One group will get standard care for diabetic foot ulcers or venous leg ulcers, including cleaning, debridement, moisture balance, offloading for foot ulcers, or compression for leg ulcers, until the ulcer closes or for up to 13 weeks. Other groups will receive weekly applications of various CAMP products plus standard care following the same schedule. The trial tests several products such as AmnioCore, Amnio Quad-Core, Amnio Tri-Core, AmnioCore Pro, and AmnioCore Pro +. During the study, participants will attend weekly visits for treatments and monitoring. Researchers will assess wound healing progress, measuring ulcer size to determine closure rates up to 12 weeks. The trial monitors safety and effectiveness by comparing the proportion of ulcers completely closed between treatment groups. Participants must commit to weekly visits and adhering to prescribed offloading methods. The total treatment period lasts up to 13 weeks with ongoing evaluation of healing outcomes.
CONDITIONS
Official Title
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 21 years old or older
- Have type 1 or type 2 diabetes
- Have a target ulcer with a size between 1.0 cm2 and 5.0 cm2 after cleaning
- Have the ulcer present for at least 4 weeks and no more than 52 weeks of standard care before screening
- Have the ulcer located on the foot with at least 50% below the ankle bone
- Have a Wagner grade 1 or 2 ulcer extending through skin layers and possibly muscle below the inner ankle
- Have adequate blood flow in the affected limb confirmed by tests done within 3 months
- If multiple ulcers, they must be at least 2 cm apart; the largest qualifying ulcer is the target
- Ulcers on the sole of the foot must be offloaded for at least 14 days before enrollment
- Agree to use the prescribed offloading method during the study
- Agree to attend weekly study visits
- Be willing and able to participate in informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Ulcer is infected, needs systemic antibiotics, or has surrounding skin infection
- Ulcer exposes tendon or bone
- Ulcer complicated by bone infection (osteomyelitis)
- Taking immunosuppressants, systemic corticosteroids over 10 mg prednisone daily, cytotoxic chemotherapy, or medications interfering with healing
- Taking hydroxyurea
- Used topical steroids on the ulcer in the past month
- Previous partial amputation of the affected foot causing deformity that prevents proper offloading
- Hemoglobin A1c (HbA1c) of 12% or higher within 3 months before screening
- Target ulcer size decreased by more than 20% in the two weeks before screening
- Target ulcer size decreased by 20% or more during the 2-week screening phase with standard care
- Have acute or inactive Charcot foot that prevents proper offloading
- Women who are pregnant or planning pregnancy within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cutting Edge Research
Circleville, Ohio, United States, 43113
Actively Recruiting
Research Team
B
Bennett M Rogers
T
Thomas Serena, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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