Back to resultsA Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
Primary Purpose
Venous Leg Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marine polysaccharide dressing
Carboxymethylcellulose dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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.
Sites / Locations
- Valley Vascular Surgery Associates
- Central Valley Vein and Wound Center
- Boston Medical Center
- Covenant Hospital
- Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Marine polysaccharide dressing
Carboxymethylcellulose dressing
Arm Description
Outcomes
Primary Outcome Measures
Wound size changes
Secondary Outcome Measures
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.
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.
Change in surface area of the dressing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03903692
Brief Title
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 Dressing and a Carboxymethylcellulose Dressing on Subjects With Lower Extremity Venous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Marine polysaccharide dressing
Arm Type
Experimental
Arm Title
Carboxymethylcellulose dressing
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Marine polysaccharide dressing
Intervention Description
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
Intervention Name(s)
Carboxymethylcellulose dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound size changes
Time Frame
Baseline to 56 days
Secondary Outcome Measure Information:
Title
Evaluation of peri-ulcer skin assessment scale
Description
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.
Time Frame
Baseline to 56 days
Title
Evaluation of subject pain perception during dressing changes using a numerical pain scale
Description
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.
Time Frame
Baseline to 56 days
Title
Change in surface area of the dressing
Time Frame
Baseline to 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Valley Vascular Surgery Associates
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Central Valley Vein and Wound Center
City
Selma
State/Province
California
ZIP/Postal Code
93662
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Covenant Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
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