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

NCT06618612 | Recruiting FDA Device

• 1 other identifier: OI-24001
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetic Foot Ulcer

Keywords

DFU; Chronic Diabetic Foot Ulcer; Non-healing DFU

Outcome Measures

Primary Outcomes (1)

• Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure

  The percentage of target ulcers achieving complete wound closure in 12 weeks

  12 weeks

Secondary Outcomes (3)

• Time to closure for the target ulcer.

  12 weeks

• Percentage wound area reduction from Treatment Visit-1 to Treatment Visit-13

  12 weeks

• The number of adverse events.

  12 weeks

Study Arms (3)

Standard of Care

OTHER

Standard of Care (SOC)

Other: Standard of Care

PuraPly AM + SOC

ACTIVE COMPARATOR

PuraPly Antimicrobial Wound Matrix along with standard of care

Other: Standard of Care; Device: PuraPly AM

PuraPly XT + SOC

ACTIVE COMPARATOR

PuraPly Antimicrobial XT Wound Matrix along with standard of care

Other: Standard of Care; Device: PuraPly XT

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 + SOC; PuraPly XT + SOC; Standard of Care

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 AM + SOC

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)

PuraPly XT + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older.
• Diagnosis of type 1 or 2 Diabetes mellitus.
• At enrollment, target ulcer with a minimum surface area of 1.0 cm2
• The target ulcer must have been present for a minimum of 4 weeks
• The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• The target ulcer must be Wagner 1 or 2 grade
• The affected limb must have adequate perfusion confirmed by vascular assessment.

You may not qualify if:

• Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• The potential subject must consent to using the prescribed offloading method for the duration of the study.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject is known to have a life expectancy of \< 6 months.
• The potential subject's target ulcer is not secondary to diabetes.
• The target ulcer is infected or there is cellulitis in the surrounding skin.
• The target ulcer exposes tendon or bone.
• There is evidence of osteomyelitis
• There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing.
• The potential subject is taking hydroxyurea.
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
• The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit.

Sponsors & Collaborators

• Organogenesis: lead
• Serena Group: collaborator

Study Sites (1)

Kent State University, College of Podiatric Medicine

Clevland, Ohio, 44103, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maribel Henao

  Organogenesis

  STUDY DIRECTOR

Central Study Contacts

Brett Madden

CONTACT

(781) 575-0775; bmadden@organo.com

Meghan Byrd

CONTACT

(781) 575-0775; mbyrd@organo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): November 19, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)