Actively Recruiting
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
Led by Organogenesis · Updated on 2025-04-04
170
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
O
Organogenesis
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus Standard of Care Alone in subjects with chronic DFUs.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age or older
- Diagnosis of type 1 or 2 Diabetes mellitus
- Target ulcer with a minimum surface area of 1.0 cm2 at enrollment
- Target ulcer present for a minimum of 4 weeks
- Target ulcer located on the foot with at least 50% below the malleolus
- Target ulcer is Wagner 1 or 2 grade
- Affected limb has adequate blood flow confirmed by vascular assessment
- If two or more ulcers, they must be at least 2 cm apart; largest qualifying ulcer is target ulcer
- Plantar ulcers must be offloaded for at least 14 days before enrollment
- Agree to use prescribed offloading method for the study duration
- Agree to attend weekly study visits required by the protocol
- Willing and able to participate in the informed consent process
You will not qualify if you...
- Life expectancy less than 6 months
- Target ulcer not caused by diabetes
- Target ulcer infected or surrounded by cellulitis
- Target ulcer exposes tendon or bone
- Evidence of osteomyelitis
- Infection requiring systemic antibiotics in target ulcer or elsewhere
- Receiving immunosuppressants, cytotoxic chemotherapy, or medications interfering with healing
- Taking hydroxyurea
- Applied topical steroids to ulcer within one month before screening
- Previous partial amputation causing deformity that prevents proper offloading
- Controlled glycated hemoglobin (HbA1c) within 3 months before screening
- Acute or inactive Charcot foot impeding proper offloading
- Pregnant or planning pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in clinical trial with investigational product within 30 days
- Medical or psychological condition interfering with study assessments
- Treated with hyperbaric oxygen therapy or matrix-like products within 30 days before screening
- Malnutrition indicator score less than 17 on Mini Nutritional Assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kent State University, College of Podiatric Medicine
Clevland, Ohio, United States, 44103
Actively Recruiting
Research Team
B
Brett Madden
CONTACT
M
Meghan Byrd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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