Venous Leg Ulcer
Conditions
Keywords
GSV, AASV, Vein, Venous, Ulcer, Varicose Vein, VLU, venous insufficiency, venous disease, chronic VLU
Brief summary
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
Detailed description
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.
Interventions
DRUGVarithena
Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Men and women; age ≥18 * Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence * Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on) * Reflux \>500 milliseconds (ms) on duplex ultrasound * Willing and able to collect wound photographs and data using an application installed on a tablet * Willing and able to return for scheduled follow-up and wound care visits * Ability to comprehend and sign informed consent form (ICF) and complete questionnaires
Exclusion criteria
* Contraindications to Varithena® 1% in accordance with the FPI * Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound * Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena® * Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8 * In the opinion of Investigator, wound would close within 12 weeks without additional treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Wound Perimeter | Baseline to 12 weeks and to 12 months | 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. |
| Number of Wound Closure at 12 Weeks | Baseline to 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. |
| Time to Wound Closure | Baseline to wound closure or to 12 months, whichever occurs first | Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | Baseline to 12 months | Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform. |
| Change in Pain | Baseline to 12 weeks and to 12 months | 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. |
| Number of Ulcer Free Days | Baseline to 12 months | Mean number of ulcer free days defined as days from baseline to date of recurrence |
| Number of Wound Recurrences | Baseline to 12 months | Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines. |
| Change on EQ-5D-5L Quality of Life Assessment | Baseline to 12 weeks and to 12 months | 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. |
| Change in VCSS | Baseline to 12 weeks and to 12 months | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Study discontinued by sponsor | 5 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Prospective Registry Cohort | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 35 Participants | — |
| Age, Categorical Between 18 and 65 years | 41 Participants | — |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 13.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 9 participants | — |
| Region of Enrollment United States | 67 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 46 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 76 |
| other Total, other adverse events | 1 / 76 |
| serious Total, serious adverse events | 6 / 76 |
Outcome results
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.
Time frame: Baseline to 12 weeks and to 12 months
Population: Based on number of wounds continuing to heal at the timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Registry Cohort | Change From Baseline in Wound Perimeter | at 12 weeks | 29.36 mm | Standard Deviation 146.13 |
| Prospective Registry Cohort | Change From Baseline in Wound Perimeter | at 12 months | 43.64 mm | Standard Deviation 2.6 |
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.
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective Registry Cohort | Number of Wound Closure at 12 Weeks | 43 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.
Time frame: Baseline to wound closure or to 12 months, whichever occurs first
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prospective Registry Cohort | Time to Wound Closure | 89 days |
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.
Time frame: Baseline to 12 weeks and to 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Registry Cohort | Change in Pain | at 12 weeks | -1.4 score on a scale | Standard Deviation 3.1 |
| Prospective Registry Cohort | Change in Pain | at 12 months | -2.5 score on a scale | Standard Deviation 3.1 |
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.
Time frame: Baseline to 12 weeks and to 12 months
Population: Analysis is based on number of wounds and not number of patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Registry Cohort | Change in VCSS | at 12 weeks | -5.8 score on a scale | Standard Deviation 5.6 |
| Prospective Registry Cohort | Change in VCSS | at 12 months | -10.0 score on a scale | Standard Deviation 7.1 |
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.
Time frame: Baseline to 12 weeks and to 12 months
Population: Statistics are based on the number of wounds and not number of patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Registry Cohort | Change on EQ-5D-5L Quality of Life Assessment | at 12 weeks | 0.066 score on a scale | Standard Deviation 0.233 |
| Prospective Registry Cohort | Change on EQ-5D-5L Quality of Life Assessment | at 12 months | 0.072 score on a scale | Standard Deviation 0.223 |
Secondary
Number of Ulcer Free Days
Mean number of ulcer free days defined as days from baseline to date of recurrence
Time frame: Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Registry Cohort | Number of Ulcer Free Days | 240.5 days | Standard Deviation 118.9 |
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.
Time frame: Baseline to 12 months
Population: 54 wounds were closed prior to the 12 month follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prospective Registry Cohort | Number of Wound Recurrences | 7 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.
Time frame: Baseline to 12 months
Population: 54 wounds were closed prior to the 12-month follow up visit.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Prospective Registry Cohort | Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | 47 wounds |