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

Medline Industries

Status

Terminated

Conditions

Venous Leg Ulcer

Treatments

Device: Marine polysaccharide dressing

Device: Carboxymethylcellulose dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT03903692

MED-2018-DIV71-026

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.