Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01701661
Other study ID # TYH4209
Secondary ID
Status Completed
Phase N/A
First received October 3, 2012
Last updated October 4, 2012
Start date September 2004
Est. completion date September 2012

Study information

Verified date October 2012
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.

The aim of the study is to compare compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.


Description:

Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date September 2012
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- patients with chronic superficial vein insufficiency

- patient must be 20-70 years old

- degree of difficulty of vein insufficiency C2-C3

- venous disability score 1-2

- patient is agreeable to the study

Exclusion Criteria:

- peripheral atherosclerotic occlusive disease

- lymphoedema

- severe concomitant disease (ASA 3-5)

- venous ulcers or unclassified skin changes

- BMI more than 35

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Operative treatment
stripping of main trunk or if previously removed, removal or ligating the refluating trunk
Other:
conservative treatment
Compression stockings class II

Locations

Country Name City State
Finland Department of Vascular Surgery, Helsinki University Central Hospital Helsinki HUS

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom relief Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination. two years No
Secondary Quality of life Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life). two years No
See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT04469361 - The Effect of Training on Hemodynamic Factors in Ballet Dancer
Recruiting NCT05633277 - Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Terminated NCT03311269 - A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency Phase 2
Withdrawn NCT01680809 - Compliance of Compression Therapy in Healed Venous Ulcerations N/A
Completed NCT00617825 - Feasibility Study of Cryotherapy for Chronic Venous Disorders N/A
Active, not recruiting NCT00270972 - The Evaluation of OrCel for the Treatment of Venous Ulcers N/A
Active, not recruiting NCT06369207 - Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Recruiting NCT04546750 - Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Active, not recruiting NCT02397226 - Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery N/A
Not yet recruiting NCT01110512 - Comparative Efficacy of Two Preparations of the Association Diosmin (450 mg) + Hesperidin (50 mg) in the Treatment of Chronic Venous Insufficiency (CVI) Phase 3
Completed NCT00565604 - Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins N/A
Completed NCT01298908 - Comparison of Treatments in Venous Insufficiency N/A
Active, not recruiting NCT00841178 - Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT N/A
Not yet recruiting NCT03652025 - The Effectiveness of Trans-catheter Foam Sclerotherapy of Pelvic and Atypical Lower Limb Varicosities N/A
Completed NCT03755180 - Exercise Training in Venous Insufficiency N/A
Completed NCT02588911 - Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency N/A