Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant are treated per Investigator's Standard of Care (SoC) and in accordance with the Full Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed ulcers during the 12 month follow-up period, VLU recurrence information is collected.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varithena | Drug | Administration procedures and volume are per standard of care, full prescribing information, and instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Wound Perimeter | Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound. | Baseline to 12 weeks and to 12 months |
| Number of Wound Closure at 12 Weeks | Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform. | Baseline to 12 weeks |
| Time to Wound Closure | Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform. | Baseline to wound closure or to 12 months, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome. | Baseline to 12 weeks and to 12 months |
| Change on EQ-5D-5L Quality of Life Assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Shao, MD | Swedish Covenant Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| University of California Davis Health |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Registry Cohort | Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Sep 27, 2021 |
Not provided
Not provided
Not provided
Not provided
Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome. |
| Baseline to 12 weeks and to 12 months |
| Change in VCSS | Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome. | Baseline to 12 weeks and to 12 months |
| Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform. | Baseline to 12 months |
| Number of Wound Recurrences | Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines. | Baseline to 12 months |
| Number of Ulcer Free Days | Mean number of ulcer free days defined as days from baseline to date of recurrence | Baseline to 12 months |
| Sacramento |
| California |
| 95817 |
| United States |
| The Vascular Experts | Darien | Connecticut | 06820 | United States |
| Pines Clinical Research | Aventura | Florida | 33180 | United States |
| Emory University Hospital | Atlanta | Georgia | 30306 | United States |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | United States |
| Mass General, Boston | Boston | Massachusetts | 02114 | United States |
| The Venous Institute of Buffalo | Buffalo | New York | 14226 | United States |
| Mercy Health Cincinnati -West Hospital | Cincinnati | Ohio | 45211 | United States |
| OhioHealth Research | Columbus | Ohio | 43214 | United States |
| Totality | Oklahoma City | Oklahoma | 73118 | United States |
| University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
| Oakville Vascular | Oakville | Ontario | L6J7S2 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Registry Cohort | Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena. |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | 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 From Baseline in Wound Perimeter | Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound. | Based on number of wounds continuing to heal at the timepoint. | Posted | Mean | Standard Deviation | mm | Baseline to 12 weeks and to 12 months | wounds | wounds |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Wound Closure at 12 Weeks | Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform. | Posted | Number | wounds | Baseline to 12 weeks | wounds | wounds |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Time to Wound Closure | Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform. | Posted | Median | 95% Confidence Interval | days | Baseline to wound closure or to 12 months, whichever occurs first | wounds | wounds |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Pain | Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome. | Analysis is based on the number of wounds and not number of patients. If a patient had more than one reported pain score during a timepoint, the worst (highest) NPRS score was used for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks and to 12 months | wounds | wounds |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change on EQ-5D-5L Quality of Life Assessment | Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome. | Statistics are based on the number of wounds and not number of patients. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks and to 12 months | wounds | wounds |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in VCSS | Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome. | Analysis is based on number of wounds and not number of patients. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks and to 12 months | wounds | wounds |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform. | 54 wounds were closed prior to the 12-month follow up visit. | Posted | Count of Units | wounds | Baseline to 12 months | wounds | wounds |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Wound Recurrences | Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines. | 54 wounds were closed prior to the 12 month follow up. | Posted | Number | 95% Confidence Interval | wounds | Baseline to 12 months | wounds | wounds |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Ulcer Free Days | Mean number of ulcer free days defined as days from baseline to date of recurrence | Posted | Mean | Standard Deviation | days | Baseline to 12 months |
|
|
Adverse events were collected during a 1 year period starting from the initiation of treatment until the subject completes the registry follow up period or withdraws.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Registry Cohort | Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV treated with Varithena. | 0 | 76 | 6 | 76 | 1 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Polyarteritis nodosa | Vascular disorders | Systematic Assessment |
| ||
| Gangrene | Vascular disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Toe amputation | Surgical and medical procedures | Systematic Assessment |
| ||
| Condition aggravated | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Keo | Boston Scientific | 425-599-3814 | Timothy.Keo@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2020 | Sep 27, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| D014648 | Varicose Veins |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077423 | Polidocanol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| >=65 years |
|
|
|
|
| wounds |
|
|
| wounds |
|
|
| wounds |
|
|
| wounds |
|
|
| wounds |
|
|
| wounds |
|
|
| Title | Denominators | Categories |
|---|
|