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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

ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrganogenesis

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Other intervention

    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)

Treatment groups

170 Participants
are divided into 3 treatment groups
Group A: Standard of CareOther 1 intervention
Group B: PuraPly AM + SOCActive comparator 2 interventions
Group C: PuraPly XT + SOCActive comparator 2 interventions

Trial outcomes

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

Time frame
12 weeks

Secondary outcomes

1

Time to closure for the target ulcer.

Time frame
12 weeks
2

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

Time frame
12 weeks
3

The number of adverse events.

Time frame
12 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Kent State University, College of Podiatric MedicineRecruiting44103, Clevland, OhioUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Organogenesis

Lead sponsor

Serena Group

Collaborator

Source ClinicalTrials.gov
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