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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-12-21

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.

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Detailed Description

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Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Marine polysaccharide dressing

Group Type EXPERIMENTAL

Marine polysaccharide dressing

Intervention Type 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.

Carboxymethylcellulose dressing

Group Type ACTIVE_COMPARATOR

Carboxymethylcellulose dressing

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No