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Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

NCT03398538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-03

No results posted yet for this study

Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

Conditions

  • Diabetic Foot Ulcer
  • Ulcer Foot
  • Diabetic Foot

Interventions

OTHER

Offloading

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

OTHER

Additional (outer) Dressing Application

Application of outer a moisture retentive dressing, and a multi-layer compression dressing.

OTHER

Mirragen Wound Matrix Dressing

Application of Mirragen to wound site along with standard of care treatment

OTHER

Fibracol Wound Dressing

Application of Fibracol Alginate along with standard of care treatment

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • ETS Wound Care, LLC

    lead INDUSTRY

Principal Investigators

  • David Armstrong, DPM, MD, PhD · USC / Salsa

  • Charles M Zelen, DPM · Professional Education and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-26
Primary Completion
2018-10-31
Completion
2018-10-31

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 NCT03398538 on ClinicalTrials.gov