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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR073614 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound Edge Debridement Group | Experimental | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. |
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| Standard care group | Active Comparator | Participants in this group will receive only the standard care of treatment for up to 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Edge Debridement | Procedure | Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Genetic Profile After Debridement in the Intervention Group. | RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group | Wound size is measured at every weekly visit. If the wound size decreased by 50% from baseline to week 4, the participant in considered having a "healing wound". If the wound size does not decreased by 50% from baseline to week 4, the participant is considered a "non-healing wound". | Baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjana Tomic-Canic, PhD | University of Miami | Principal Investigator |
| Robert Kirsner, MD/PhD | 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 | Wound Edge Debridement Group | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
| FG001 | Standard Care Group | Participants in this group will receive only the standard care of treatment for up to 4 weeks. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wound Edge Debridement Group | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
| 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 |
| 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 the Genetic Profile After Debridement in the Intervention Group. | RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement. | Change in Differentially Expressed Genes (DEGs) from pre-deberidment to post-debridement samples in the "wound edge debridement" group. | Posted | Number | Number of Differentially Expressed Genes | Baseline and 4 weeks |
|
4 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 | Wound Edge Debridement Group | Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks. Wound Edge Debridement: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep venous thrombosis | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Kirsner | University of Miami | 3052434472 | rkirsner@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 11, 2020 | Jan 26, 2026 | 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 |
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| Standard of Care Treatment | Other | Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
|
| BG001 | Standard Care Group | Participants in this group will receive only the standard care of treatment for up to 4 weeks. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percent Rate of Healing Versus Non-healing Wounds Within Each Treatment Group | Wound size is measured at every weekly visit. If the wound size decreased by 50% from baseline to week 4, the participant in considered having a "healing wound". If the wound size does not decreased by 50% from baseline to week 4, the participant is considered a "non-healing wound". | Posted | Number | percentage of participants | Baseline to 4 weeks |
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|
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| 0 |
| 27 |
| 1 |
| 27 |
| 0 |
| 27 |
| EG001 | Standard Care Group | Participants in this group will receive only the standard care of treatment for up to 4 weeks. Standard of Care Treatment: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |