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SkinTE® in the Treatment of Venous Leg Wounds

NCT03881267 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-04-04

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 Venous Leg Wounds

Conditions

  • Venous Leg Ulcer
  • Venous Stasis
  • Venous Stasis Ulcer

Interventions

OTHER

Human Autologous Homologous Skin Construct

Application of a autologous human derived skin polar units

OTHER

Additional Outer Dressing Application

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

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
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2021-03-23
Completion
2021-03-23

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 NCT03881267 on ClinicalTrials.gov