Effect of Hyaluronic Acid ECM on Venous Ulcers

NCT02930499 | Suspended

• 1 other identifier: ML-HM-0115-VLU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcers

Outcome Measures

Primary Outcomes (1)

• Effect of Hyalomatrix® plus standard care on the incidence of wound healing

  16 weeks

Secondary Outcomes (1)

• Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing

  16 weeks

Study Arms (2)

Hyaluronic Acid ECM (Hyalomatrix)

EXPERIMENTAL

Hyalomatrix ECM will be applied to the target ulcer once weekly

Device: Hyalomatrix extra-cellular matrix

Non-Adherent wound dressing (Mepilex)

ACTIVE COMPARATOR

Mepilex wound dressing will be applied to the target ulcer once weekly

Device: Mepilex wound dressing

Interventions

Hyalomatrix extra-cellular matrix DEVICE

An exta-cellular matrix made from hyaluronic acid

Hyaluronic Acid ECM (Hyalomatrix)

Mepilex wound dressing DEVICE

A siliconized non-adhesive foam wound dressing

Also known as: non-adhesive foam wound dressing

Non-Adherent wound dressing (Mepilex)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Calvary Hospital, Bronx, NY: lead

Study Sites (1)

Vascular and Wound Care Center, University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oscar M Alvarez, PhD

  Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Wound Care Center

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: October 12, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)