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Amniotic Membrane Allograft Application in the Management of Venous Leg Ulcerations

NCT02929056 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-12-16

Study results available
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Summary

The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the standard of care treatment for VLUs. The biologic product that will be used in this study is called AmnioExCel™.

Conditions

  • Varicose Ulcer
  • Venous Insufficiency

Interventions

BIOLOGICAL

AmnioExCel dressing and compression therapy

Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers

PROCEDURE

SOC alginate dressing and compression therapy

Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing

Sponsors & Collaborators

  • Clemson University

    collaborator OTHER

  • BioDlogics

    collaborator INDUSTRY

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Thomas Oliver, MD · Prisma Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-09-06
Completion
2019-10-29
FDA Drug
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 NCT02929056 on ClinicalTrials.gov