Effect of Hyaluronic Acid ECM on Venous Ulcers

March 28, 2017 updated by: Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Hyaluronic Acid Extracellular Matrix (Hyalomatrix®) in the Management of Chronic Venous Ulcers

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • Vascular and Wound Care Center, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months
  2. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
  3. Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.

Exclusion Criteria:

  1. Ulcers of non-venous etiology
  2. Subject has a known sensitivity to hyaluronic acid
  3. Presence of wound infection as determined by clinical signs and symptoms
  4. Subject has any evidence of peripheral arterial disease (PAD)
  5. Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
  6. Pregnancy or lactation at time of treatment.
  7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
  8. Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
  9. History of alcohol or drug abuse.
  10. Subject allergic to a broad spectrum of primary & secondary dressing materials, including occlusive dressings and the adhesives on such dressings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid ECM (Hyalomatrix)
Hyalomatrix ECM will be applied to the target ulcer once weekly
Device: Hyalomatrix extra-cellular matrix
An exta-cellular matrix made from hyaluronic acid
Active Comparator: Non-Adherent wound dressing (Mepilex)
Mepilex wound dressing will be applied to the target ulcer once weekly
Device: Mepilex wound dressing
A siliconized non-adhesive foam wound dressing
Other Names:
  • non-adhesive foam wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calvary Hospital, Bronx, NY

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML-HM-0115-VLU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Ulcers

Clinical Trials on Hyalomatrix extra-cellular matrix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe