PuraPly AM for Diabetic Foot Ulcers
(PREPARE Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking immunosuppressants, cytotoxic chemotherapy, or hydroxyurea, as these may interfere with wound healing.
What data supports the effectiveness of the treatment PuraPly AM for Diabetic Foot Ulcers?
Research shows that using a collagen-rich hydrogel, similar to the components in PuraPly AM, can effectively inhibit bacterial growth and promote healing in chronic wounds. Additionally, studies on other collagen-based treatments have demonstrated improved healing rates in diabetic foot ulcers compared to standard care.12345
Is PuraPly AM safe for use in humans?
What makes the PuraPly AM treatment unique for diabetic foot ulcers?
Research Team
Maribel Henao
Principal Investigator
Organogenesis
Eligibility Criteria
This trial is for people with chronic diabetic foot ulcers (DFUs) that haven't healed. Participants should be adults who can follow the study procedures and visit schedules. Those with infected wounds, allergies to collagen or antimicrobial agents used in the study, or other health conditions that could interfere with wound healing are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Randomization
Participants are randomized into different treatment groups
Treatment
Participants receive weekly treatment with either PuraPly AM + SOC, PuraPly XT + SOC, or SOC alone
Healing Confirmation
A visit to confirm maintenance of complete wound closure for subjects that heal
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP)
Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) is already approved in United States for the following indications:
- Management of Nonhealing Diabetic Foot Ulcers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Organogenesis
Lead Sponsor
Serena Group
Collaborator
Serena Group
Collaborator