Clinical trial NCT03903692: A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
Official title: A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Wound Size From Baseline
timeFrame: Baseline to 56 days
Secondary outcomes:
measure: Evaluation of Peri-ulcer Skin Assessment Scale
timeFrame: Baseline to 56 days
measure: Score on a Pain Scale.
timeFrame: Baseline to 56 days
measure: Change in Surface Area of the Dressing
timeFrame: Baseline to 56 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Vascular Surgery Associates
state: California
city: Selma
country: United States
facility: Central Valley Vein and Wound Center
state: California
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Saginaw
country: United States
facility: Covenant Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
References: