Back to resultsEffect of Hyaluronic Acid ECM on Venous Ulcers
Primary Purpose
Venous Ulcers
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyalomatrix extra-cellular matrix
Mepilex wound dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Ulcers
Eligibility Criteria
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.
Sites / Locations
- Vascular and Wound Care Center, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyaluronic Acid ECM (Hyalomatrix)
Non-Adherent wound dressing (Mepilex)
Arm Description
Hyalomatrix ECM will be applied to the target ulcer once weekly
Mepilex wound dressing will be applied to the target ulcer once weekly
Outcomes
Primary Outcome Measures
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Secondary Outcome Measures
Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
Full Information
NCT ID
NCT02930499
First Posted
September 1, 2016
Last Updated
March 28, 2017
Sponsor
Calvary Hospital, Bronx, NY
1. Study Identification
Unique Protocol Identification Number
NCT02930499
Brief Title
Effect of Hyaluronic Acid ECM on Venous Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Suspended
Why Stopped
Investigator relocation
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Calvary Hospital, Bronx, NY
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic Acid ECM (Hyalomatrix)
Arm Type
Experimental
Arm Description
Hyalomatrix ECM will be applied to the target ulcer once weekly
Arm Title
Non-Adherent wound dressing (Mepilex)
Arm Type
Active Comparator
Arm Description
Mepilex wound dressing will be applied to the target ulcer once weekly
Intervention Type
Device
Intervention Name(s)
Hyalomatrix extra-cellular matrix
Intervention Description
An exta-cellular matrix made from hyaluronic acid
Intervention Type
Device
Intervention Name(s)
Mepilex wound dressing
Other Intervention Name(s)
non-adhesive foam wound dressing
Intervention Description
A siliconized non-adhesive foam wound dressing
Primary Outcome Measure Information:
Title
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar M Alvarez, PhD
Organizational Affiliation
Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular and Wound Care Center, University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Hyaluronic Acid ECM on Venous Ulcers
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