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

Calvary Hospital, Bronx, NY1 site in 1 country20 target enrollmentJanuary 2016

ConditionsVenous Ulcers

Overview

Phase: N/A
Intervention: Not specified
Conditions: Venous Ulcers
Sponsor: Calvary Hospital, Bronx, NY
Enrollment: 20
Locations: 1
Primary Endpoint: Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Status: Suspended
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Calvary Hospital, Bronx, NY

Responsible Party

Principal Investigator

Oscar M. Alvarez, PhD

Director Wound Care Center

Calvary Hospital, Bronx, NY

Eligibility Criteria

Inclusion Criteria

•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
•Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
•Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.

Exclusion Criteria

•Ulcers of non-venous etiology
•Subject has a known sensitivity to hyaluronic acid
•Presence of wound infection as determined by clinical signs and symptoms
•Subject has any evidence of peripheral arterial disease (PAD)
•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.
•Pregnancy or lactation at time of treatment.
•Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
•Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
•History of alcohol or drug abuse.
•Subject allergic to a broad spectrum of primary \& secondary dressing materials, including occlusive dressings and the adhesives on such dressings.