Trial Outcomes & Findings for Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU) (NCT NCT03257254)

NCT ID: NCT03257254

Last Updated: 2021-12-14

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline to 12 weeks and to 12 months
• Results posted on: 2021-12-14

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	76
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	9
Overall Study Study discontinued by sponsor	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prospective Registry Cohort n=76 Participants 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.
Age, Categorical <=18 years	0 Participants n=76 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=76 Participants
Age, Categorical >=65 years	35 Participants n=76 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 13.7 • n=76 Participants
Sex: Female, Male Female	30 Participants n=76 Participants
Sex: Female, Male Male	46 Participants n=76 Participants
Region of Enrollment Canada	9 participants n=76 Participants
Region of Enrollment United States	67 participants n=76 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks and to 12 months

Population: Based on number of wounds continuing to heal at the timepoint.

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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Change From Baseline in Wound Perimeter at 12 months	43.64 mm Standard Deviation 2.6
Change From Baseline in Wound Perimeter at 12 weeks	29.36 mm Standard Deviation 146.13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Number of Wound Closure at 12 Weeks	43 wounds

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Time to Wound Closure	89 days Interval 62.0 to 117.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Change in Pain at 12 weeks	-1.4 score on a scale Standard Deviation 3.1
Change in Pain at 12 months	-2.5 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline to 12 weeks and to 12 months

Population: Statistics are based on the number of wounds and not number of patients.

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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Change on EQ-5D-5L Quality of Life Assessment at 12 weeks	0.066 score on a scale Standard Deviation 0.233
Change on EQ-5D-5L Quality of Life Assessment at 12 months	0.072 score on a scale Standard Deviation 0.223

SECONDARY outcome

Timeframe: Baseline to 12 weeks and to 12 months

Population: Analysis is based on number of wounds and not number of patients.

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.

Outcome measures

Measure	Prospective Registry Cohort n=80 wounds 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.
Change in VCSS at 12 weeks	-5.8 score on a scale Standard Deviation 5.6
Change in VCSS at 12 months	-10.0 score on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 54 wounds were closed prior to the 12-month follow up visit.

Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.

Outcome measures

Measure	Prospective Registry Cohort n=54 wounds 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.
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date	47 wounds

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 54 wounds were closed prior to the 12 month follow up.

Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.

Outcome measures

Measure	Prospective Registry Cohort n=54 wounds 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.
Number of Wound Recurrences	7 wounds Interval 5.4 to 24.9

SECONDARY outcome

Timeframe: Baseline to 12 months

Mean number of ulcer free days defined as days from baseline to date of recurrence

Outcome measures

Measure	Prospective Registry Cohort n=76 Participants 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.
Number of Ulcer Free Days	240.5 days Standard Deviation 118.9

Adverse Events

Prospective Registry Cohort

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prospective Registry Cohort n=76 participants at risk 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.
Vascular disorders Peripheral arterial occlusive disease	1.3% 1/76 • 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.
General disorders Asthenia	1.3% 1/76 • 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.
Infections and infestations Staphylococcal infection	1.3% 1/76 • 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.
Renal and urinary disorders Acute kidney injury	1.3% 1/76 • 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.
Infections and infestations Sepsis	2.6% 2/76 • 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.
Vascular disorders Polyarteritis nodosa	1.3% 1/76 • 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.
Vascular disorders Gangrene	1.3% 1/76 • 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.
Infections and infestations Cellulitis	2.6% 2/76 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/76 • 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.
Surgical and medical procedures Toe amputation	1.3% 1/76 • 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.
General disorders Condition aggravated	1.3% 1/76 • 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.

Other adverse events

Measure	Prospective Registry Cohort n=76 participants at risk 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.
Skin and subcutaneous tissue disorders Blister	1.3% 1/76 • 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.

Additional Information

Timothy Keo

Boston Scientific

Phone: 425-599-3814

Email: Timothy.Keo@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place