Overview

This trial is active, not recruiting.

Condition venous ulcers
Treatments hyalomatrix wound dressing, mepilex wound dressing
Sponsor Calvary Hospital, Bronx, NY
Start date January 2016
End date February 2017
Trial size 20 participants
Trial identifier NCT02930499, ML-HM-0115-VLU

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 wound dressing 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hyalomatrix wound dressing will be applied to the target ulcer once weekly
hyalomatrix wound dressing
An exta-cellular matrix wound dressing made from hyaluronic acid
(Active Comparator)
Mepilex wound dressing will be applied to the target ulcer once weekly
mepilex wound dressing non-adhesive foam wound dressing
A siliconized non-adhesive foam wound dressing

Primary Outcomes

Measure
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
time frame: 16 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 21 years up to 90 years old.

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.

Additional Information

Official title 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
Principal investigator Oscar M Alvarez, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Calvary Hospital, Bronx, NY.