Effect of Hyaluronic Acid ECM on Venous Ulcers

Venous Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02930499
• Other study ID #: ML-HM-0115-VLU
• Status: Suspended
• Phase: N/A
• First received: September 1, 2016
• Last updated: March 28, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Calvary Hospital, Bronx, NY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcers

Intervention

Device:
• Hyalomatrix extra-cellular matrix
An exta-cellular matrix made from hyaluronic acid
• Mepilex wound dressing
A siliconized non-adhesive foam wound dressing

Locations

Country	Name	City	State
United States	Vascular and Wound Care Center, University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Calvary Hospital, Bronx, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Hyalomatrix® plus standard care on the incidence of wound healing		16 weeks
Secondary	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