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Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers

NCT05506215 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-03-05

No results posted yet for this study

Summary

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.

Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

Conditions

  • Diabetic Foot
  • Chronic Foot Ulcer
  • Wound Healing
  • Foot Ulcer

Interventions

DEVICE

SynPath Acellular Dermal Matrix plus Off-loading Device

Application of SynPath

DEVICE

Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device

Application Wound Dressing composed of Collagen and Alginate

Sponsors & Collaborators

  • PolyNovo Biomaterials Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Charles M Zelen, DPM, FACFAC · Profession Education and Research Institute, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-10
Primary Completion
2024-02-26
Completion
2024-02-26
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05506215 on ClinicalTrials.gov