Compression Therapy Following Endothermal Ablation

NCT02522845 | Completed Results

• 1 other identifier: 15/LO/0181
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be looking at the effect of compression therapy in patients having endovenous treatment for truncal incompetence of their varicose veins using either radiofrequency ablation (RFA) or endovenous laser therapy (EVLT). Patients will be randomised to either the compression group (group A) or the no compression group (group B). The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

Conditions

Varicose Veins

Keywords

Varicose Veins; Compression Stockings; Laser Ablation; Catheter Ablation, Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Patient's Post-procedure Pain Score Using a Visual Analogue Scale (VAS)

  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)

  Up to 10 days

Secondary Outcomes (9)

• The Generic Quality of Life Score Using the EQ-5D Score

  Up to 6 months

• The Specific Quality of Life Score Using the Aberdeen Varicose Vein Questionnaire (AVVQ) Score

  Up to 6 months

• The Specific Quality of Life Score Using the CIVIQ Score

  Up to 6 months

• The Clinical Score Using the Venous Clinical Severity Score

  Up to 6 months

• The Degree of Bruising and Phlebitis

  Up to 6 months

Study Arms (2)

Compression

ACTIVE COMPARATOR

Patients randomised to this group will be asked to wear Class II compression stockings for 1 week

Device: Class II Compression Stockings (no specific device used)

No Compression

NO INTERVENTION

Patients randomised to this group will not be provided with any compression

Interventions

Class II Compression Stockings (no specific device used) DEVICE

This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins

Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years of age
• Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex

You may not qualify if:

• Current DVT
• Recurrent varicose veins
• Patients requiring adjuvant treatment of varicose veins
• Arterial disease (ABPI\<0.8)
• Vein diameter \< 3mm
• Patient who are unwilling to participate
• Inability or unwillingness to complete questionnaires

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital, Imperial College London

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

1. Power of the study was decreased from 90% to 80%. 2. The use of analgesia was not recorded so that it is unclear whether the pain score observed was with or without analgesia.

Results Point of Contact

• Title: Mr Roshan Bootun
• Organization: Imperial College London

r.bootun@imperial.ac.uk

+442033117335

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 6, 2022
• Results First Posted: July 27, 2020

Record last verified: 2022-08

Locations

GB (1)