Actively Recruiting
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing Multiple Human Placental-Based Skin Substitutes and Standard Care Versus Standard Care Alone in Treating Hard-to-Heal Diabetic Foot Ulcers
Led by StimLabs · Updated on 2026-03-02
272
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
StimLabs
Lead Sponsor
S
SerenaGroup, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of four different dehydrated complete human placental membrane products, known as Cellular, Acellular, Matrix-like Products (CAMPs), combined with standard care versus standard care alone in healing hard-to-heal diabetic foot ulcers. This study uses a unique modified platform trial design to compare multiple skin substitute products within one clinical trial. The goal is to achieve complete wound closure of diabetic foot ulcers over a 12-week period. Participants will be randomly assigned to receive one of the four placental membrane products—Revita, Relese, Cogenex, or Enverse—each applied weekly alongside standard care, or to receive standard care alone. Standard care includes cleaning, debridement, moisture balance for the ulcer, and offloading to reduce pressure on the foot. Treatments continue weekly until the ulcer heals or up to 12 weeks, whichever comes first. During the study, participants will attend weekly visits for treatments and assessments. Researchers will monitor the percentage of ulcers that fully close within 12 weeks, the time it takes for ulcers to close, reduction in ulcer size, pain changes, adverse events, and improvements in quality of life. The study includes detailed evaluations such as imaging of ulcers and vascular assessments to ensure adequate blood flow. Participants' safety and wound healing progress will be closely followed throughout the trial and up to 14 weeks.
CONDITIONS
Brief Title
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older
- Diagnosis of type 1 or type 2 Diabetes mellitus
- Target ulcer with a surface area between 1.0 cm2 and 25.0 cm2 measured after debridement
- Target ulcer present for at least 4 weeks and no more than 52 weeks of standard care prior to screening
- Target ulcer located on the foot with at least 50% below the ankle bone (malleolus)
- Target ulcer must be full thickness without exposed bone
- Adequate blood flow to the affected limb confirmed by recent vascular assessment (ABI 0.7 to ≤1.3, TBI ≥0.6, TCOM ≥40 mmHg, or biphasic PVR)
- If multiple ulcers, they must be at least 2 cm apart; largest qualifying ulcer will be the target
- Plantar ulcers must be offloaded for at least 14 days before enrollment
- Willing to use prescribed offloading method during the study
- Agree to attend weekly study visits
- Able and willing to participate in informed consent process
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Infected ulcer or cellulitis in surrounding skin
- Ulcer exposing tendon or bone
- Osteomyelitis affecting the ulcer
- Infection requiring systemic antibiotics
- Use of immunosuppressants or chemotherapy that may interfere with healing
- Use of hydroxyurea
- Topical steroids applied to ulcer within one month before screening
- Previous partial amputation causing deformity that prevents proper offloading
- HbA1c greater than or equal to 12% within 3 months before screening
- Ulcer size reduced by more than 20% in the 2 weeks before screening
- Ulcer size decreased by 20% or more during 2-week screening phase with standard care
- Acute or inactive Charcot foot preventing offloading
- Pregnancy or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational treatment trial within 30 days
- Medical or psychological conditions interfering with study assessments
- Ulcer treated with hyperbaric oxygen therapy or CAMP within 30 days before screening
- Malnutrition indicator score less than 17 on Mini Nutrition Assessment tool
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 their assigned treatment product along with standard care procedures such as cleaning, debridement, ulcer moisture balance, and offloading until ulcer closure or a maximum of 12 weeks, whichever occurs first.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 5 locations
1
SerenaGroup Omaha Research Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
2
Wound Care of Tulsa
Tulsa, Oklahoma, United States, 74135
Actively Recruiting
3
SerenaGroup Research South
Jefferson Hills, Pennsylvania, United States, 15025
Not Yet Recruiting
4
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States, 16201
Not Yet Recruiting
5
SerenaGroup Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
K
Kristy Breisinger
T
Thomas Serena, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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