Trial Outcomes & Findings for Compression Therapy Following Endothermal Ablation (NCT NCT02522845)

NCT ID: NCT02522845

Last Updated: 2022-09-06

Results Overview

Patients indicating level of pain they were having using a VAS scale. The scale is a 100mm line drawn going from 0-100 (0=no pain; 100=worse pain)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 204 participants
• Primary outcome timeframe: Up to 10 days
• Results posted on: 2022-09-06

Participant Flow

The trial period ran from May 2015 to December 2018

Patients not meeting inclusion criteria

Participant milestones

Measure	Compression Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
Overall Study STARTED	100	104
Overall Study COMPLETED	63	69
Overall Study NOT COMPLETED	37	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Compression n=100 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=104 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging	Total n=204 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 17 • n=100 Participants	49.6 years STANDARD_DEVIATION 15 • n=104 Participants	49.7 years STANDARD_DEVIATION 16 • n=204 Participants
Sex: Female, Male Female	42 Participants n=100 Participants	58 Participants n=104 Participants	100 Participants n=204 Participants
Sex: Female, Male Male	58 Participants n=100 Participants	46 Participants n=104 Participants	104 Participants n=204 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	100 participants n=100 Participants	104 participants n=104 Participants	204 participants n=204 Participants
Body Mass Index	27.3 kg/m^2 STANDARD_DEVIATION 5 • n=100 Participants	27.0 kg/m^2 STANDARD_DEVIATION 7 • n=104 Participants	27.1 kg/m^2 STANDARD_DEVIATION 6 • n=204 Participants

PRIMARY outcome

Timeframe: Up to 10 days

Patients indicating level of pain they were having using a VAS scale. The scale is a 100mm line drawn going from 0-100 (0=no pain; 100=worse pain)

Outcome measures

Measure	Compression n=63 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=69 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
Patient's Post-procedure Pain Score Using a Visual Analogue Scale (VAS)	18.7 mm Interval 7.58 to 36.9	27.8 mm Interval 13.0 to 53.6

SECONDARY outcome

Timeframe: Up to 6 months

Population: This is a patient-completed scoring instrument and not every patient filled/completed this.

The EQ-5D is a quality of life scale with 5 statements with 3 possible answers. Each answer is scored from 1 to 3 (1=best; 3=worse). Each answer is then collated (from 11111 to 33333). Using a calculator, these answers are translated into a scale which goes from -0.073 to 1.0 (-0.073= worse; 1=best).

Outcome measures

Measure	Compression n=46 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=44 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Generic Quality of Life Score Using the EQ-5D Score	0.761 units on a scale Interval 0.69 to 1.0	0.891 units on a scale Interval 0.722 to 1.0

SECONDARY outcome

Timeframe: Up to 6 months

The disease-specific AVVQ score has 13 items with different scoring for each item. The final scores are added and then the percentage is calculated. The final score goes from 0 to 100 (0=best; 100= worse)

Outcome measures

Measure	Compression n=46 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=44 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Specific Quality of Life Score Using the Aberdeen Varicose Vein Questionnaire (AVVQ) Score	7.3 units on a scale Interval 3.0 to 16.3	10.1 units on a scale Interval 2.5 to 16.7

SECONDARY outcome

Timeframe: Up to 6 months

Population: This is a patient-completed scoring instrument and not every patient filled/completed this.

This is a quality of life scale going from 0 to 100 (0=best; 100=worse)

Outcome measures

Measure	Compression n=46 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=44 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Specific Quality of Life Score Using the CIVIQ Score	7.1 units on a scale Interval 1.8 to 20.5	5.4 units on a scale Interval 1.8 to 16.1

SECONDARY outcome

Timeframe: Up to 6 months

This is a scoring system with 10 items graded from 0 to 3 (0=best/absent; 3=worse/present). The individual scores are then added to obtain the final score (0=best; 30=worse).

Outcome measures

Measure	Compression n=46 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=44 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Clinical Score Using the Venous Clinical Severity Score	2 units on a scale Interval 1.0 to 4.0	1 units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Up to 6 months

The degree of bruising and phlebitis will be assessed using a pre-determined score (0=0%; 1= <25% of treated vein affected; 2 = 25-50% ; 3 = 50-75%; 4 = 75-100% and 5 = extending beyond the treated vein. Using this pre-defined score, patients were divided into two groups (those with a score of 1 or less, and those with a score of 2-5).

The outcome measure is the percentage of patients with a score of 1 or less.

Outcome measures

Measure	Compression n=63 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=69 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Degree of Bruising and Phlebitis	85 percentage	80 percentage

SECONDARY outcome

Timeframe: Up to 3 weeks

Population: Patient in no compression group not provided with stockings

This looked at the number of days since intervention that patients stopped wearing compression stockings if they were allocated to the compression group

Outcome measures

Measure	Compression n=100 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Number of Days After Treatment That Patients Were Compliant With the Intervention	7 day Interval 0.0 to 20.0	—

SECONDARY outcome

Timeframe: 1 month

This looked at the number of days since intervention before patients are able to resume their normal activities or go back to work

Outcome measures

Measure	Compression n=63 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=69 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
The Time Taken to Return to Work and Normal Activities	2 day Interval 1.0 to 3.0	3 day Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 6 months

This looked at the occlusion of the target vein following treatment as assessed by an ultrasound duplex

Outcome measures

Measure	Compression n=46 Participants Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=44 Participants Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
Occlusion Rates at 6 Months	41 Participants	41 Participants

SECONDARY outcome

Timeframe: 1 week

This looks at the cost of both interventions

Outcome measures

Outcome data not reported

Adverse Events

Compression

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

No Compression

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Compression n=100 participants at risk Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=104 participants at risk Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
Vascular disorders DVT	0.00% 0/100 • 6 months	0.96% 1/104 • 6 months

Other adverse events

Measure	Compression n=100 participants at risk Patients randomised to this group will be asked to wear Class II compression stockings for 1 week after 24 hours of compression bandaging Class II Compression Stockings (no specific device used): This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins	No Compression n=104 participants at risk Patients randomised to this group will not be provided with any compression after 24 hours of compression bandaging
Vascular disorders Superficial Vein Thrombosis (SVT)	0.00% 0/100 • 6 months	0.00% 0/104 • 6 months
Vascular disorders Ecchymosis	15.0% 15/100 • Number of events 15 • 6 months	20.2% 21/104 • Number of events 21 • 6 months

Additional Information

Mr Roshan Bootun

Imperial College London

Phone: +442033117335

Email: r.bootun@imperial.ac.uk

Results disclosure agreements

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