Effect of Hyaluronic Acid ECM on Venous Ulcers

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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02930499

Enrollment

Registered

2016-10-12

Start date

2016-01-31

Completion date

2018-12-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Ulcers

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.

Interventions

DEVICEHyalomatrix extra-cellular matrix

An exta-cellular matrix made from hyaluronic acid

DEVICEMepilex wound dressing

A siliconized non-adhesive foam wound dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026