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

Not Applicable

Terminated

Interventions: Device: Marine polysaccharide dressing
Device: Carboxymethylcellulose dressing

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Marine polysaccharide dressing	Marine polysaccharide dressing	-
Carboxymethylcellulose dressing	Carboxymethylcellulose dressing	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Wound Size From Baseline	Baseline to 56 days	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

Secondary Outcome Measures

Name	Time	Method
Score on a Pain Scale.	Baseline to 56 days	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.
Evaluation of Peri-ulcer Skin Assessment Scale	Baseline to 56 days	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.
Change in Surface Area of the Dressing	Baseline to 56 days

Locations (5): Valley Vascular Surgery Associates
🇺🇸
Fresno, California, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
Central Valley Vein and Wound Center
🇺🇸
Selma, California, United States
Covenant Hospital
🇺🇸
Saginaw, Michigan, United States
Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States