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A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903692
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Brief Summary:
Venous leg ulcers are lower extremity ulcers that develop due to sustained venous hypertension resulting from chronic venous insufficiency. Varicose veins, deep vein thrombosis, poor calf muscle function, arterio-venous fistulae, obesity and history of leg fracture are some of the risk factors for venous ulceration. Numerous dressing types exist to treat these ulcers. This study will compare a marine polysaccharide (MPS) dressing to a carboxymethylcellulose dressing to determine which dressing better manages these wounds with regard to wound size and periwound skin condition. Subjects will be randomized to receive either MPS-Ag dressing or CMC-Ag dressing.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: Marine polysaccharide dressing Device: Carboxymethylcellulose dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Evaluation of a Marine Polysaccharide Dressing and a Carboxymethylcellulose Dressing on Subjects With Lower Extremity Venous Ulcers
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Marine polysaccharide dressing Device: Marine polysaccharide dressing
The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.

Active Comparator: Carboxymethylcellulose dressing Device: Carboxymethylcellulose dressing
The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.




Primary Outcome Measures :
  1. Wound size changes [ Time Frame: Baseline to 56 days ]

Secondary Outcome Measures :
  1. Evaluation of peri-ulcer skin assessment scale [ Time Frame: Baseline to 56 days ]
    The peri-ulcer skin assessment scale will be used to assess the peri-ulcer skin. There are 9 systemically quoted items including oedema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, and itching lesions. Each item will be measured for an extension score from 0-4 and as severity score from 0-3. The global score is the extension score multiplied by the severity score. All global scores are added together to encompass a total global score. For all sub-score values, a value of 0 is the lowest value.

  2. Evaluation of subject pain perception during dressing changes using a numerical pain scale [ Time Frame: Baseline to 56 days ]
    The pain score will be evaluated with a numeric rating scale from 0 to 10 with 0 representing no pain and 10 representing pain as bad as it could be.

  3. Change in surface area of the dressing [ Time Frame: Baseline to 56 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able and willing to comply with requirements of this trial protocol
  • Voluntarily signed informed consent before any trial related procedures are performed
  • Subjects must be able to communicate effectively with study personnel
  • Subject has lower extremity venous ulcer wound, as determined by site PI.
  • Subject has adequate circulation as determined by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
  • Subjects should not be allergic to silver (Ag).
  • Size of subject's wound is between 1 squared centimeter and 100 squared centimeters.
  • Duration of subject's wound is less than 52 weeks.

Exclusion Criteria:

  • Subjects who are pregnant, nursing, or planning to become pregnant during the course of the study.
  • Subjects who have known allergies to any ingredient(s) in the clinical products used in this study.
  • Subjects who do not wish to use products derived from shellfish.
  • Subjects with substance use disorder.
  • Subjects with active infection or currently receiving antibiotic treatment.
  • Subjects who are currently enrolled in another research study which includes investigational treatment and/or medication.
  • Subjects judged by the investigator or sub-investigator to be inappropriate as a subject of this study.
  • Subject has previous or current systemic disease(s) which, in the judgement of the site PI, is likely to interfere with the study. However, subjects with well-controlled diabetes mellitus (HbA1C < 8.5) shall be permitted.

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): NCT03903692


Contacts
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Contact: Stephanie Martynenko 2242163822 smartynenko@medline.com
Contact: Lori Rotolo lrotolo@medline.com

Locations
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United States, California
Valley Vascular Surgery Associates Recruiting
Fresno, California, United States, 93720
Contact: Stephanie Martynenko    224-216-3822    smartynenko@medline.com   
Central Valley Vein and Wound Center Recruiting
Selma, California, United States, 93662
Contact: Stephanie Martynenko    224-216-3822    smartynenko@medline.com   
United States, Michigan
Covenant Hospital Not yet recruiting
Saginaw, Michigan, United States, 48602
Contact: Stephanie Martynenko, BS       smartynenko@medline.com   
Principal Investigator: David Gustavison         
United States, North Carolina
Wake Forest Baptist Health Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephanie Martynenko    224-216-3822    smartynenko@medline.com   
Sponsors and Collaborators
Medline Industries
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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT03903692    
Other Study ID Numbers: MED-2018-DIV71-026
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents