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SkinTE™ in the Treatment of Diabetic Foot Wounds

NCT03881254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-08-26

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 a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Conditions

  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Ulcer Foot

Interventions

OTHER

Human Autologous Homologous Skin Construct

Application of a autologous human derived skin polar units

OTHER

Additional Outer Dressing Applicaiton

Application of Moisture retentive dressing, and a multi-layer compression dressing

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

Fibracol Wound Dressing

Application of Collagen Alginate Dressing

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • PolarityTE

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2021-07-28
Completion
2021-07-28

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 NCT03881254 on ClinicalTrials.gov