|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02890563 |
|
Date of registration:
|
31/08/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
|
|
Scientific title:
|
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy |
|
Date of first enrolment:
|
August 2016 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02890563 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Finland
| | | | | | | |
|
Contacts
|
|
Name:
|
Toni Pihlaja, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oulu University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
- Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2
to C4
- Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
Exclusion Criteria:
- History of pulmonary embolism or deep venous thrombosis
- Large (>12mm) truncal vein diameter
- CEAP C5-C6
- Patient unwilling to participate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Varicose Veins
|
|
Intervention(s)
|
|
Device: Class II Compression Stockings
|
|
Primary Outcome(s)
|
|
Truncal vein occlusion rate
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively
[Time Frame: 30days]
|
|
Time required returning to normal work and activity level
[Time Frame: 14 days]
|
|
Aberdeen Varicose Veins Questionnaire (AVVQ)
[Time Frame: 6 months]
|
|
Post-operative pain assessed with visual analogue scale (VAS)
[Time Frame: 10 days]
|
|
Compliance with compression stockings
[Time Frame: 7 days]
|
|
Painkillers usage after treatment
[Time Frame: 10 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|