Venous Leg Ulcer
Conditions
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.
Interventions
DEVICEMarine 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.
DEVICECarboxymethylcellulose 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.
Sponsors
Medline Industries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Wound Size From Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Peri-ulcer Skin Assessment Scale | Baseline to 56 days | 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. |
| Score on a Pain Scale. | Baseline to 56 days | 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. |
| Change in Surface Area of the Dressing | Baseline to 56 days | — |
Countries
United States
Participant flow
Pre-assignment details
13 subjects were withdrawn from the study and 6 subjects had unusable data. The analysis was performed on the remaining 43 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Marine Polysaccharide Dressing 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. | 23 |
| Carboxymethylcellulose Dressing 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. | 20 |
| Total | 43 |
Baseline characteristics
| Characteristic | Carboxymethylcellulose Dressing | Total | Marine Polysaccharide Dressing |
|---|---|---|---|
| Age, Continuous | 66.75 years STANDARD_DEVIATION 11.2 | 65.98 years STANDARD_DEVIATION 12.15 | 65.30 years STANDARD_DEVIATION 13.14 |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 27 Participants | 12 Participants |
| Race/Ethnicity, Customized Latino | 4 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 21 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 1 / 20 |
| other Total, other adverse events | 16 / 23 | 12 / 20 |
| serious Total, serious adverse events | 2 / 23 | 2 / 20 |
Outcome results
Primary
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
Time frame: Baseline to 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marine Polysaccharide Dressing | Percent Change in Wound Size From Baseline | 45.61 % change in wound area | Standard Deviation 36.76 |
| Carboxymethylcellulose Dressing | Percent Change in Wound Size From Baseline | 56.41 % change in wound area | Standard Deviation 61.43 |
Secondary
Change in Surface Area of the Dressing
Time frame: Baseline to 56 days
Population: Percent change was calculated as the area of the dressing at time of application minus the area of the dressing at time of removal, divided by the area of the dressing at time of application, times 100.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marine Polysaccharide Dressing | Change in Surface Area of the Dressing | 0.76 Percent change | Standard Deviation 42.11 |
| Carboxymethylcellulose Dressing | Change in Surface Area of the Dressing | 12.65 Percent change | Standard Deviation 48.99 |
Secondary
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.
Time frame: Baseline to 56 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marine Polysaccharide Dressing | Evaluation of Peri-ulcer Skin Assessment Scale | 23.5 Score on a scale | Standard Deviation 18.15 |
| Carboxymethylcellulose Dressing | Evaluation of Peri-ulcer Skin Assessment Scale | 24.39 Score on a scale | Standard Deviation 18.77 |
Secondary
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.
Time frame: Baseline to 56 days
Population: All participants at all dressing changes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Marine Polysaccharide Dressing | Score on a Pain Scale. | 1.50 Score on a scale | Standard Deviation 2.46 |
| Carboxymethylcellulose Dressing | Score on a Pain Scale. | 1.65 Score on a scale | Standard Deviation 2.54 |