A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers

A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers

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.

Study Overview

• Status: Terminated
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Marine polysaccharide dressing; Device: Carboxymethylcellulose dressing

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Valley Vascular Surgery Associates
    • Selma, California, United States, 93662
      • Central Valley Vein and Wound Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Covenant Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Wound Size From Baseline	Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison	Baseline to 56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Peri-ulcer Skin Assessment Scale	peri-ulcer skin assessment scale is used for assessment. There are 9 systemically items edema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, & itching lesions. Each is measured for an extension score 0-4 (0=none; 1=punctual, no extension; 2=local, no extension, does not include total ulcer perimeter; 3=includes total ulcer perimeter, does not include spread beyond; 4=spreads beyond total ulcer perimeter) & severity score from 0-3 (=-none; 1=only detected following examination; 2=clearly apparent; 3=as evident as the wound). The global score is the extension score multiplied by the severity score. Global scores are added together to a total score. Total score scale range 0 - 70 with 0 being the best score and 70 being the worst. All sub-score values, 0 is best score; higher values indicate worsening wounds.	Baseline to 56 days
Score on a Pain Scale.	Pain was assessed at each dressing change over the course of the study on a scale of 0-10 with 0 being no pain and 10 being the worst pain. The pain score reported was the average of all scores taken at each dressing change for all patients from baseline to 56 days.	Baseline to 56 days
Change in Surface Area of the Dressing		Baseline to 56 days

Collaborators and Investigators

• Sponsor: Medline Industries

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: MED-2018-DIV71-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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