Actively Recruiting
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
Led by Samaritan Biologics · Updated on 2025-05-13
170
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
S
Samaritan Biologics
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
CONDITIONS
Official Title
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of type 1 or 2 Diabetes mellitus
- Target foot ulcer with surface area between 1.0 and 20.0 cm2 after debridement
- Ulcer present for at least 4 weeks and no more than 52 weeks prior to screening
- Ulcer located on foot with at least 50% below the malleolus (ankle bone)
- Ulcer classified as Wagner grade 1 or 2, extending through dermis or subcutaneous tissue without exposed tendon or bone
- Adequate blood flow to affected limb confirmed by vascular tests within 3 months
- If multiple ulcers, ulcers must be at least 2 cm apart; largest qualifying ulcer is target
- Offloading of plantar ulcers for at least 14 days before enrollment
- Consent to use prescribed offloading method during study
- Willingness to attend weekly study visits
- Ability and willingness to provide informed consent
You will not qualify if you...
- Life expectancy less than 6 months
- Ulcer not caused by diabetes
- Infected target ulcer or surrounding cellulitis
- Evidence of osteomyelitis at target ulcer
- Infection requiring systemic antibiotics
- Use of immunosuppressants or cytotoxic chemotherapy
- Topical steroid use on ulcer within 1 month before screening
- Previous partial foot amputation causing offloading issues
- Target ulcer reduced by more than 20% in size during 2 weeks prior to screening
- Target ulcer reduced by 20% or more during 2-week screening phase
- Hemoglobin A1c of 12% or higher within 3 months before screening
- Acute or inactive Charcot foot affecting offloading
- Pregnancy or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational treatment study in past 30 days
- Medical or psychological conditions interfering with assessments
- Hyperbaric oxygen or CAMP treatment in past 30 days
- Malnutrition with Mini Nutritional Assessment score below 17
AI-Screening
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Trial Site Locations
Total: 1 location
1
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
Research Team
J
Jeremy J Mercuri, PhD
CONTACT
J
Jerry Chang, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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