Effect of Hyaluronic Acid ECM on Venous Ulcers

Not Applicable

Suspended

• Conditions: Venous Ulcers
• Interventions: Device: Hyalomatrix extra-cellular matrix; Device: Mepilex wound dressing

• Registration Number: NCT02930499
• Lead Sponsor: Calvary Hospital, Bronx, NY

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid ECM (Hyalomatrix)	Hyalomatrix extra-cellular matrix	Hyalomatrix ECM will be applied to the target ulcer once weekly
Non-Adherent wound dressing (Mepilex)	Mepilex wound dressing	Mepilex wound dressing will be applied to the target ulcer once weekly

Primary Outcome Measures

Name	Time	Method
Effect of Hyalomatrix® plus standard care on the incidence of wound healing	16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vascular and Wound Care Center, University Hospital; 🇺🇸 Newark, New Jersey, United States