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Trial record 3 of 3 for:    hyalomatrix

Effect of Hyaluronic Acid ECM on Venous Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930499
Recruitment Status : Suspended (Investigator relocation)
First Posted : October 12, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, 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.

Condition or disease Intervention/treatment Phase
Venous Ulcers Device: Hyalomatrix extra-cellular matrix Device: Mepilex wound dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

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Arm Intervention/treatment
Experimental: Hyaluronic Acid ECM (Hyalomatrix)
Hyalomatrix ECM will be applied to the target ulcer once weekly
Device: Hyalomatrix extra-cellular matrix
An exta-cellular matrix made from hyaluronic acid

Active Comparator: Non-Adherent wound dressing (Mepilex)
Mepilex wound dressing will be applied to the target ulcer once weekly
Device: Mepilex wound dressing
A siliconized non-adhesive foam wound dressing
Other Name: non-adhesive foam wound dressing




Primary Outcome Measures :
  1. Effect of Hyalomatrix® plus standard care on the incidence of wound healing [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930499


Locations
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United States, New Jersey
Vascular and Wound Care Center, University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
Investigators
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Principal Investigator: Oscar M Alvarez, PhD Program Director, Vascular and Wound Care Center, University Hospital, Newark, NJ
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Responsible Party: Oscar M. Alvarez, PhD, Director Wound Care Center, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT02930499    
Other Study ID Numbers: ML-HM-0115-VLU
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Varicose Ulcer
Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases