Trial Outcomes & Findings for Pilot RCT Evaluating a One Stop Vein Clinic (NCT NCT02557542)

Results Overview

Quality of life using the EuroQoL EQ-5D scale which is a generic quality of life score. Minimum score = -0.073 (worse) and maximum score is 1.0 (best).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

3 months

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	One Stop Vein Clinic Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation	Normal Care Pathway Patients randomised to this group will be invited to the Normal Care Pathway One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation
Overall Study STARTED	3	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	One Stop Vein Clinic Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation	Normal Care Pathway Patients randomised to this group will be invited to the Normal Care Pathway One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation
Overall Study Poor recruitment	3	0

Baseline Characteristics

Pilot RCT Evaluating a One Stop Vein Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One Stop Vein Clinic n=3 Participants Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation	Normal Care Pathway Patients randomised to this group will be invited to the Normal Care Pathway One Stop Vein Clinic: Same day diagnosis and treatment Radiofrequency ablation: Venous ablation Endovenous laser ablation: Venous ablation Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate): Venous ablation	Total n=3 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	—	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	—	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

Quality of life using the EuroQoL EQ-5D scale which is a generic quality of life score. Minimum score = -0.073 (worse) and maximum score is 1.0 (best).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

Patient satisfaction using a patient satisfaction questionnaire. Minimum score = 0 and maximum score = 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

EuroQoL's EQ-5D instrument -\> Measures health-related quality of life (minimum score = -0.073 (worst); maximum score = 1.0 (best)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

Aberdeen Varicose veins Questionnaire -\> disease-specific quality of life questionnaire (Minimum score = 0 (best); Maximum score = 100 (worst)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 weeks

Population: Data was not collected from any participants at 3 months due to early study termination

Time from referral from GP to intervention. Number of patients treated within 18 weeks. Minimum = 0 and maximum = number of patients recruited in the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

Cost of treating patients through the normal referral pathways compared to treating them on the intervention pathway

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Data was not collected from any participants due to early study termination

Time to return to normal activities or to work for patients on the normal referral pathway and intervention group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from any participants at 3 months due to early study termination

Comparing societal costs with the normal referral pathway compared to the new intervention pathway

Outcome measures

Outcome data not reported

Adverse Events

One Stop Vein Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Care Pathway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Roshan Bootun

Imperial College London

Phone: +442033117335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place