Health Trials

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

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

Treatments tested in this trial

  • Standard of Care
  • PuraPly AM
  • PuraPly XT

Treatment groups

170 Participants
are divided into 3 treatment groups

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 collaborators

Organogenesis

Lead sponsor

Serena Group

Collaborator

Source ClinicalTrials.gov