Actively Recruiting
A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Led by Cellution Biologics · Updated on 2025-10-21
120
Participants Needed
8
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic foot ulcers (DFUs) are a common and serious complication for people with diabetes, often challenging to heal with standard treatments. This research evaluates how well a new product, Amnion-Intermediate-Chorion (AIC), made from dehydrated human placental tissue, works alongside standard care compared to standard care alone in closing these ulcers. The trial is a Phase 4, randomized study focused on improving healing outcomes for diabetic foot ulcers. Participants will receive standard care, which includes cleaning, removing damaged tissue, managing moisture, and offloading pressure from the ulcer. One group will receive only this standard care weekly for up to 12 weeks or until the ulcer closes. The other group will receive the same standard care plus weekly application of the AIC sheet product during the same period. This treatment phase begins after a screening visit and continues based on ulcer healing or treatment duration limits. During the study, participants will attend regular visits to assess ulcer healing, pain changes, wound size, and any side effects. Researchers will measure how many ulcers fully close within 1 to 12 weeks and track the time it takes to heal. Quality of life changes will also be evaluated. The study includes monitoring safety and effectiveness through these assessments, with participants involved for up to 12 weeks of treatment.
CONDITIONS
Brief Title
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of type 1 or 2 Diabetes mellitus
- Hemoglobin A1c (HbA1c) level less than 12% (108 mmol/mol)
- Target ulcer surface area between 0.7 cm2 and 20.0 cm2 measured after debridement
- Target ulcer present for at least 4 weeks before screening visit
- Ulcer located on the foot with at least 50% below the malleolus (ankle bone)
- Ulcer classified as Wagner grade 1 or 2, extending through dermis or subcutaneous tissue, possibly involving muscle but below medial malleolus
- Adequate blood flow to affected limb confirmed by vascular tests within 3 months
- If multiple ulcers, they are at least 2 cm apart, with the largest qualifying ulcer selected
- Agree to use prescribed offloading method during study
- Agree to attend required study visits
- Willing and able to participate in informed consent process
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Ulcer infected or surrounding skin with cellulitis
- Evidence of bone infection (osteomyelitis) at ulcer site
- Infection requiring systemic antibiotics
- Use of immunosuppressants or cytotoxic chemotherapy
- Topical steroid use on ulcer within 1 month before screening
- Previous partial amputation causing deformity preventing proper offloading
- Ulcer size reduced by more than 20% in 2 weeks before screening
- Mini Nutritional Assessment score less than 17
- Acute or inactive Charcot foot preventing offloading
- Women of childbearing potential who are pregnant, planning pregnancy, or not using contraception
- Currently on dialysis or planning to start dialysis
- Medical or psychological conditions interfering with assessments
- Hyperbaric oxygen therapy or dehydrated human placental tissue treatment within 30 days before screening
- Known allergy to ofloxacin, vancomycin, or amphotericin antibiotics
- Participation in another investigational treatment trial within 30 days
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 treatment with standard of care including wound cleaning, debridement, ulcer moisture balance, and offloading. Some participants also receive an Amnion-Intermediate-Chorion (AIC) sheet product as part of their treatment.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 8 locations
1
005
Santa Rosa, California, United States, 95403
Actively Recruiting
2
001
Jacksonville, Florida, United States, 32216
Actively Recruiting
3
003
Chicago, Illinois, United States, 60611
Actively Recruiting
4
007
Mooresville, North Carolina, United States, 28117
Actively Recruiting
5
002
Rocky Mount, North Carolina, United States, 27804
Actively Recruiting
6
008
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
7
004
Philadelphia, Pennsylvania, United States, 19146
Actively Recruiting
8
006
Hilton Head Island, South Carolina, United States, 29926
Active, Not Recruiting
Research Team
B
Bryanna Finstein, BS
C
Cellution Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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