Actively Recruiting
A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial 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
13 weeks
Total Duration
On this page
Sponsors
O
Organogenesis
Lead Sponsor
S
Serena Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of adding Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) to standard care compared to standard care alone for people with chronic diabetic foot ulcers (DFUs). This prospective, multi-center, randomized, controlled trial aims to better manage nonhealing DFUs by comparing different wound treatment methods. The study is sponsored by Organogenesis and focuses on wound healing outcomes over a 12-week period. Participants will be randomly assigned to one of three groups: standard of care (SOC) alone, PuraPly Antimicrobial Wound Matrix (PuraPly AM) plus SOC, or PuraPly Antimicrobial XT Wound Matrix (PuraPly XT) plus SOC. The PuraPly devices are collagen-based wound matrices coated with an antimicrobial agent called polyhexamethylenebiguanide hydrochloride (PHMB). Following screening, subjects will attend weekly visits for up to 12 weeks where treatments and healing progress will be monitored. Those who heal will have a confirmation visit two weeks later to ensure wound closure is maintained. During the study, participants will undergo regular assessments including wound measurements and evaluations of healing progress. Researchers will monitor the time to complete closure, the percentage reduction in wound area, and record any adverse events during the 12-week treatment period. The study involves weekly visits and requires participants to follow prescribed offloading methods for the foot ulcer. The overall goal is to determine if these antimicrobial collagen matrices improve healing compared to standard wound care alone.
CONDITIONS
Brief 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
- Target ulcer present for a minimum of 4 weeks
- Target ulcer located on the foot with at least 50% of the ulcer below the malleolus
- Target ulcer must be Wagner grade 1 or 2
- Affected limb must have adequate blood flow confirmed by vascular assessment
- If two or more ulcers exist, they must be at least 2 cm apart; the largest qualifying ulcer will be the target
- Plantar foot ulcers must be offloaded for at least 14 days before enrollment
- Consent to use prescribed offloading method during the study
- Agree to attend weekly study visits
- Willing and able 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 cellulitis in surrounding skin
- Ulcer exposing tendon or bone
- Evidence of osteomyelitis
- Infection requiring systemic antibiotics
- Receiving immunosuppressants, cytotoxic chemotherapy, or medications interfering with wound healing
- Taking hydroxyurea
- Use of topical steroids on ulcer within 1 month prior to screening
- Previous partial amputation causing deformity that prevents proper offloading
- Uncontrolled glycated hemoglobin (HbA1c) within 3 months before screening
- Acute or inactive Charcot foot preventing proper offloading
- Pregnant or considering pregnancy within 6 months
- End stage renal disease requiring dialysis
- Participation in another investigational product trial within 30 days
- Medical or psychological conditions interfering with study assessments
- Treatment with hyperbaric oxygen therapy or similar products within 30 days
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Weekly for up to 12 weeks
Participants receive either standard of care alone or a purified native type 1 collagen extracellular matrix with antimicrobial plus standard of care for nonhealing diabetic foot ulcers.
Weekly visits for up to 12 weeks
Duration - 2 weeks after healing
Participants who heal their ulcers attend a healing confirmation visit to confirm maintenance of complete wound closure.
1 visit (in-person)
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
M
Meghan Byrd
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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