Actively Recruiting
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
Led by Cellution Biologics · Updated on 2025-10-21
120
Participants Needed
8
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
CONDITIONS
Official 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) 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
- Target ulcer located on the foot with at least 50% below the malleolus
- Target ulcer is Wagner grade 1 or 2, extending through dermis or subcutaneous tissue, may involve muscle below medial malleolus but no exposed tendon or bone
- Adequate blood flow in affected limb confirmed by vascular assessment within 3 months
- If two or more ulcers are present, they must be at least 2 cm apart; the largest ulcer meeting criteria is the target ulcer
- Consent to use prescribed off-loading method during the 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
- Target ulcer not caused by diabetes
- Target ulcer is infected or surrounding skin has cellulitis
- Evidence of bone infection complicating the target ulcer
- Infection in target ulcer or other location requiring systemic antibiotics
- Receiving immunosuppressants or cytotoxic chemotherapy, including corticosteroids over 10 mg prednisone daily
- Topical steroids applied to ulcer within 1 month before screening
- Previous partial amputation causing deformity that prevents proper off-loading
- Target ulcer surface area reduced by more than 20% in 2 weeks before screening
- Mini Nutritional Assessment score less than 17
- Acute or inactive Charcot foot that impedes proper off-loading
- Women of childbearing potential who are pregnant, planning pregnancy within 4 months, or unwilling to use contraception
- Currently require dialysis or plan to start dialysis
- Medical or psychological conditions interfering with study assessments
- Treated with hyperbaric oxygen therapy or dehydrated human placental tissue in 30 days before screening
- Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics
- Participation in another investigational treatment trial within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Cellution Research
CONTACT
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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