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Internal stakeholders withdrew funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marine polysaccharide dressing | Experimental |
| |
| Carboxymethylcellulose dressing | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marine polysaccharide dressing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Vascular Surgery Associates | Fresno | California | 93720 | United States | ||
| Central Valley Vein and Wound Center |
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13 subjects were withdrawn from the study and 6 subjects had unusable data. The analysis was performed on the remaining 43 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2022 |
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| Carboxymethylcellulose dressing | Device | 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. |
|
| 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. | Baseline to 56 days |
| Change in Surface Area of the Dressing | Baseline to 56 days |
| Selma |
| California |
| 93662 |
| United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Covenant Hospital | Saginaw | Michigan | 48602 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | % change in wound area | Baseline to 56 days |
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| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 56 days |
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| 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. | All participants at all dressing changes. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 56 days |
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| Secondary | Change in Surface Area of the Dressing | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline to 56 days |
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8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 23 | 2 | 23 | 16 | 23 |
| EG001 | 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. | 1 | 20 | 2 | 20 | 12 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient fell due to pre-existing condition of neuropathy condition not related to her wound. Found not to be related to the products in the study. |
| |
| Serious Adverse Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | This SAE was not related to the study products and relevant medical history to this SAE was diabetes, heart burn, deep vein thrombosis (DVT), irregular heartbeat, and hypertension. subject completed final visit. |
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| All-Cause Mortality | Renal and urinary disorders | Non-systematic Assessment | Death - The unexpected adverse event was end organ failure and not related to study products. |
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| Serious Adverse Event | Gastrointestinal disorders | Non-systematic Assessment | Subject was admitted to the hospital due to rectal bleeding. Found not to be related to study products. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | skin conditions found not to be related to study products. |
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| Adverse Event | Blood and lymphatic system disorders | Non-systematic Assessment | Events were found not to be related to study products. |
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| Adverse Event | Surgical and medical procedures | Non-systematic Assessment | Ablation. not to be related to study products. |
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| Adverse Event | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Found to be related to CoFlex product, not the investigational product. |
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| Adverse Event | Gastrointestinal disorders | Non-systematic Assessment | Ulcers, found not to be related to study products. |
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| Adverse Event | Infections and infestations | Non-systematic Assessment | Suspected infections were found not to be related to study products. |
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| Adverse Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pulmonary congestion with pleural effusion. Found not to be related to study products. |
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| Adverse Event | Renal and urinary disorders | Non-systematic Assessment | Venaseal and end of organ failure. Found not to be related to study products. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Miller | Medline Industries, LP | 630-418-6891 | jamiller@medline.com |
| Feb 19, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Latino |
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| African American |
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| Asian |
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| Participants |
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