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

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Evaluation of a Marine Polysaccharide Dressing and a Carboxymethylcellulose Dressing on Subjects With Lower Extremity Venous Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Marine polysaccharide dressing
* Device: Carboxymethylcellulose dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Marine polysaccharide dressing<br> | Device: Marine polysaccharide dressing<br>* 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.<br>|
| Active Comparator: Carboxymethylcellulose dressing<br> | Device: Carboxymethylcellulose dressing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound size changes |  | Baseline to 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of peri-ulcer skin assessment scale | 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. | Baseline to 56 days | 
| Evaluation of subject pain perception during dressing changes using a numerical pain scale | 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. | Baseline to 56 days | 
| Change in surface area of the dressing |  | Baseline to 56 days |