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

NCT03903692 | Terminated Results FDA Device

• 1 other identifier: MED-2018-DIV71-026
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of Peri-ulcer Skin Assessment Scale

  Baseline to 56 days

• Score on a Pain Scale.

  Baseline to 56 days

• Change in Surface Area of the Dressing

  Baseline to 56 days

Study Arms (2)

Marine polysaccharide dressing

EXPERIMENTAL

Device: Marine polysaccharide dressing

Carboxymethylcellulose dressing

ACTIVE COMPARATOR

Device: Carboxymethylcellulose dressing

Interventions

Marine polysaccharide dressing DEVICE

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.

Marine polysaccharide dressing

Carboxymethylcellulose dressing DEVICE

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.

Carboxymethylcellulose dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (5)

Valley Vascular Surgery Associates

Fresno, California, 93720, United States

Location

Central Valley Vein and Wound Center

Selma, California, 93662, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Covenant Hospital

Saginaw, Michigan, 48602, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Julie Miller
• Organization: Medline Industries, LP

jamiller@medline.com

630-418-6891

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: September 30, 2019
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (5)