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| Name | Class |
|---|---|
| BSN Medical Inc | INDUSTRY |
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The goal of the study is to investigate the effectiveness of Cutimed Sorbact (Study Device) in modifying bacterial load in venous leg ulcers (VLU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cutimed® Sorbact® | Experimental | Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. |
|
| Acticoat® | Active Comparator | Participants in this group will receive the Acticoat intervention for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutimed® Sorbact® | Device | Dialkylcarbomoyl chloride based wound dressing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bacterial Load | Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples | Baseline, Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Rate | Wound healing rate (in cm^2/week) will be calculated by measuring the wound area | Up 6 weeks |
| Percentage of Subjects With Complete Healing | The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cutimed® Sorbact® | Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing |
| FG001 | Acticoat® | Participants in this group will receive the Acticoat intervention for 6 weeks. Acticoat®: Silver impregnated contact layer dressing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cutimed® Sorbact® | Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing |
| BG001 | Acticoat® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Bacterial Load | Mean change in bacterial load in Colony Forming Units (CFU)/grams will be assessed from tissue samples | Posted | Mean | Standard Deviation | CFU/gram | Baseline, Up to 8 weeks |
|
Up to 8 weeks from start date
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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 | Cutimed® Sorbact® | Participants in this group will receive the Cutimed Sorbact intervention for 6 weeks. Cutimed® Sorbact®: Dialkylcarbomoyl chloride based wound dressing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cutaneous infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadar Lev-Tov, MD | University of Miami | 305-243-4472 | hlevtov@med.miami.edu |
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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 | Sep 17, 2020 | May 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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Due to the nature of the study and products, investigator blinding is unrealistic and subject blinding is unlikely. Research staff will avoid naming the dressing or suggesting the assignment to the subjects. However, an independent monitor with experience in treating wounds will be blinded to the treatment assignment and will confirm healing outcomes based on images.
| Acticoat® |
| Device |
Silver impregnated contact layer dressing |
|
| Up to 8 weeks |
| Pain as Measured by VAS Scores | The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported. | Up to 8 weeks |
| Wound Quality of Life (WQoL) Scores | WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is "not at all" and 5 is "very much". WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported. | Up to 8 weeks |
| EQ-5D-5L Quality of Life Scores | The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is "no problems" and 5 is "extreme problems". Difference in scores will be reported from last visit compared to baseline will be reported. | Up to 8 weeks |
| Number of Adverse Events | As assessed by treating physician | Up to 8 weeks |
| Preference to receive wound care closer to home |
|
| Lack of healing |
|
Participants in this group will receive the Acticoat intervention for 6 weeks.
Acticoat®: Silver impregnated contact layer dressing
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Childbearing potential | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Tobacco use | Count of Participants | Participants |
|
| Length of tobacco use | Length of tobacco use in years (mean) | Mean | Standard Deviation | years (mean) |
|
| Tobacco cessation years | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Wound Healing Rate | Wound healing rate (in cm^2/week) will be calculated by measuring the wound area | Posted | Mean | Standard Deviation | cm^2/week | Up 6 weeks |
|
|
|
| Secondary | Percentage of Subjects With Complete Healing | The percentage of subjects achieving complete healing of ulcer at the evaluation of treating physician will be reported | Posted | Number | percent of patients | Up to 8 weeks |
|
|
|
| Secondary | Pain as Measured by VAS Scores | The Pain Visual Analog Scale (VAS) has range from 0 (no pain) to 100 (worst possible pain). Mean change in scores will be reported from last visit compared to baseline will be reported. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks |
|
|
|
| Secondary | Wound Quality of Life (WQoL) Scores | WQoL is a 17 item questionnaire with each question scored on a 5 point scale, where 0 is "not at all" and 5 is "very much". WQoL has a total score ranging from 0 to 85 with a lower score indicating better quality of life. Mean change in scores will be reported from last visit compared to baseline will be reported. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks |
|
|
|
| Secondary | EQ-5D-5L Quality of Life Scores | The Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) is averaged based off the 5 point scale, where 0 is "no problems" and 5 is "extreme problems". Difference in scores will be reported from last visit compared to baseline will be reported. | Posted | Mean | Standard Deviation | units on a scale | Up to 8 weeks |
|
|
|
| Secondary | Number of Adverse Events | As assessed by treating physician | Posted | Number | number of adverse events | Up to 8 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| EG001 | Acticoat® | Participants in this group will receive the Acticoat intervention for 6 weeks. Acticoat®: Silver impregnated contact layer dressing | 0 | 16 | 0 | 16 | 2 | 16 |
| Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Squamous cell carcinoma |
|
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |