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

Part of paid clinical trials in Clevland, Ohio.

Sponsor
Organogenesis
Study ID
NCT06618612
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care — OTHER
    Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change.
  • PuraPly AM — DEVICE
    PuraPly Antimicrobial Wound Matrix is a 2-layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)
  • PuraPly XT — DEVICE
    PuraPly Antimicrobial XT Wound Matrix is a 5- layer cross-linked extracellular matrix (PCMP) scaffolding that consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB)

Study Details

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.

Key Dates

Start date
Aug 19, 2024
Status verified
Apr 2025
Primary completion
Aug 19, 2026
Completion
Nov 19, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard of Care
    Standard of Care (SOC)
  • Active Comparator: PuraPly AM + SOC
    PuraPly Antimicrobial Wound Matrix along with standard of care
  • Active Comparator: PuraPly XT + SOC
    PuraPly Antimicrobial XT Wound Matrix along with standard of care

Primary Outcome Measure

Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kent State University, College of Podiatric MedicineClevlandOhio44103
Nina Kovolyan

Find similar trials in Clevland, OH

By research site
Kent State University, College of Podiatric Medicine· Clevland, OH

Related Studies