Venous Leg UlcerNCT03903692
A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers
A study testing Marine polysaccharide dressing and Carboxymethylcellulose dressing in people with Venous Leg Ulcer, run by Medline Industries at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Marine polysaccharide dressing and Carboxymethylcellulose dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Sep 2019to 21 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Medical Center
Boston, Massachusetts, 02118
Valley Vascular Surgery Associates
Fresno, California, 93720
Covenant Hospital
Saginaw, Michigan, 48602
Central Valley Vein and Wound Center
Selma, California, 93662
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Marine polysaccharide dressing, Carboxymethylcellulose dressing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine polysaccharide dressingDevice
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 dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Marine polysaccharide dressing | Experimental | Not described Receives: Device: Marine polysaccharide dressing |
| Carboxymethylcellulose dressing | Active comparator | Not described Receives: Device: Carboxymethylcellulose dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Wound Size From Baseline
Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison
Measured: Baseline to 56 days
Secondary outcomes (3)
Evaluation of Peri-ulcer Skin Assessment Scale
peri-ulcer skin assessment scale is used for assessment. There are 9 systemically items edema, erythema, white atrophy, venous pigmentation, papulovesicular erythema, hyperkeratosis, purpuric patches, telengiectasis, \& itching lesions. Each is measured for an extension score 0-4 (0=none; 1=punctual, no extension; 2=local, no extension, does not include total ulcer perimeter; 3=includes total ulcer perimeter, does not include spread beyond; 4=spreads beyond total ulcer perimeter) \& severity score from 0-3 (=-none; 1=only detected following examination; 2=clearly apparent; 3=as evident as the wound). The global score is the extension score multiplied by the severity score. Global scores are added together to a total score. Total score scale range 0 - 70 with 0 being the best score and 70 being the worst. All sub-score values, 0 is best score; higher values indicate worsening wounds.
Measured: Baseline to 56 days
Score on a Pain Scale.
Pain was assessed at each dressing change over the course of the study on a scale of 0-10 with 0 being no pain and 10 being the worst pain. The pain score reported was the average of all scores taken at each dressing change for all patients from baseline to 56 days.
Measured: Baseline to 56 days
Change in Surface Area of the Dressing
Measured: Baseline to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start30 Sep 2019
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Why it stopped: Internal stakeholders withdrew funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903692
- Sponsor's protocol ID
- MED-2018-DIV71-026
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2019
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of a Marine Polysaccharide (MPS) Dressing and a Carboxymethylcellulose (CMC) Dressing on Subjects With Lower Extremity Venous Ulcers
- ClinicalTrials.gov ID
- NCT03903692
- Acronym / sponsor ID
- MED-2018-DIV71-026
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal stakeholders withdrew funding.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marine polysaccharide dressing | Experimental | Device: Marine polysaccharide dressing |
| Carboxymethylcellulose dressing | Active comparator | Device: Carboxymethylcellulose dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marine polysaccharide dressingThe 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. | Device | Marine polysaccharide dressing |
| Carboxymethylcellulose dressingThe 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. | Device | Carboxymethylcellulose dressing |
Primary outcome
Percent Change in Wound Size From Baseline
Time frame: Baseline to 56 days
Evaluate and compare the percent change in wound size from first to last visit; therefore, percentage change in wound area (mean (t-test) and median (Mann-Whitney U-test)) from first to last visit was calculated for comparison
3 secondary outcomes
Evaluation of Peri-ulcer Skin Assessment Scale
Time frame: Baseline to 56 days
Score on a Pain Scale.
Time frame: Baseline to 56 days
Change in Surface Area of the Dressing
Time frame: Baseline to 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marine polysaccharide dressing and Carboxymethylcellulose dressing in people with Venous Leg Ulcer, run by Medline Industries at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Wound Size From Baseline (time frame: Baseline to 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.