Effect of Hyaluronic Acid ECM on Venous Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Venous Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic Acid ECM (Hyalomatrix)

Hyalomatrix ECM will be applied to the target ulcer once weekly

Group Type EXPERIMENTAL

Hyalomatrix extra-cellular matrix

Intervention Type DEVICE

An exta-cellular matrix made from hyaluronic acid

Non-Adherent wound dressing (Mepilex)

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

Group Type ACTIVE_COMPARATOR

Mepilex wound dressing

Intervention Type DEVICE

A siliconized non-adhesive foam wound dressing

Interventions

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Hyalomatrix extra-cellular matrix

An exta-cellular matrix made from hyaluronic acid

Intervention Type DEVICE

Mepilex wound dressing

A siliconized non-adhesive foam wound dressing

Intervention Type DEVICE

Other Intervention Names

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non-adhesive foam wound dressing

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No