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SDRM® vs. Collagen for Diabetic Foot Ulcers

NCT05883098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-28

No results posted yet for this study

Summary

Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.

Conditions

  • Diabetic Foot
  • Ulcer Foot
  • Wound Heal

Interventions

PROCEDURE

Wound debridement

The study's wounds will be mechanically debrided before the experimental or active comparator devices are applied. Debridation will be performed by a trained clinician using a curette. Necrotic tissue and slough will be removed during this procedure.

DEVICE

Wound closure matrix application

After wound debridement, the patients will receive the application of a wound closure matrix as dictated by their randomization allocation.

Sponsors & Collaborators

Principal Investigators

  • Jose L Ramirez Garcia Luna, MD, PhD · McGill University

  • Brock A Liden, DPM · WAFL Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-01-31
Completion
2023-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883098 on ClinicalTrials.gov