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Effect of Hyaluronic Acid ECM on Venous Ulcers

NCT02930499 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-30

No results posted yet for this study

Summary

The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. The study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.

Conditions

  • Venous Ulcers

Interventions

DEVICE

Hyalomatrix extra-cellular matrix

An exta-cellular matrix made from hyaluronic acid

DEVICE

Mepilex wound dressing

A siliconized non-adhesive foam wound dressing

Sponsors & Collaborators

  • Calvary Hospital, Bronx, NY

    lead OTHER

Principal Investigators

  • Oscar M Alvarez, PhD · Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-07-31
Completion
2018-12-31

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 NCT02930499 on ClinicalTrials.gov