Effect of Hyaluronic Acid ECM on Venous Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Venous Ulcers

Intervention / Treatment
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* Device: Hyalomatrix extra-cellular matrix
* Device: Mepilex wound dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 16 weeks |