- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903692
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
March 9, 2023 updated by: Medline Industries
A Comparative Evaluation of a Marine Polysaccharide Dressing and a Carboxymethylcellulose Dressing on Subjects With Lower Extremity Venous Ulcers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Keri Joregenson, MBA
- Phone Number: 8476433616
- Email: kajoregenson@medline.com
Study Contact Backup
- Name: Taylor Graef
- Email: Tgraef@medline.com
Study Locations
-
-
California
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Fresno, California, United States, 93720
- Valley Vascular Surgery Associates
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Selma, California, United States, 93662
- Central Valley Vein and Wound Center
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Michigan
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Saginaw, Michigan, United States, 48602
- Covenant Hospital
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound size changes
Time Frame: Baseline to 56 days
|
Baseline to 56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of peri-ulcer skin assessment scale
Time Frame: Baseline to 56 days
|
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
Time Frame: Baseline to 56 days
|
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
Time Frame: Baseline to 56 days
|
Baseline to 56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Actual)
February 21, 2023
Study Completion (Actual)
February 21, 2023
Study Registration Dates
First Submitted
April 2, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (Actual)
April 4, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-2018-DIV71-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Venous Leg Ulcer
-
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-
Tactile MedicalCompletedVenous Insufficiency | Venous Leg Ulcer | Chronic Venous Insufficiency | Venous Ulcer | Venous Stasis UlcerUnited States
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DeRoyal Industries, Inc.Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National InstituteCompletedVenous Leg Ulcer | Venous Insufficiency of LegIreland
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Ortec InternationalCompletedVenous Leg Ulcer | Venous Stasis UlcerUnited States
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W.L.Gore & AssociatesRecruitingVenous Leg Ulcer | Venous Stasis | Venous Stenosis | Venous Occlusion | Venous Ulcer | Venous Thromboses | Venous Disease | Vein Thrombosis | Vein Occlusion | Vein DiseaseUnited States
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Firstkind LtdTerminatedLeg Ulcer | Venous Leg Ulcer | Venous UlcerCanada
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-
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