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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02641600
Other study ID # 35/18.02.2015
Secondary ID
Status Recruiting
Phase N/A
First received December 21, 2015
Last updated May 10, 2016
Start date December 2015
Est. completion date April 2017

Study information

Verified date May 2016
Source University of Patras
Contact Stavros K Kakkos, MD, PhD, RVT
Phone 302613603406
Email kakkos@upatras.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings


Description:

Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Primary varicose veins causing pain/ache located only at the calf level

Exclusion Criteria:

- Venous ulceration

- Dermatitis

- Itching

- Superficial vein thrombosis

- Peripheral arterial disease

- Symptoms of non-venous origin

- Previous use of elastic stockings

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Elastic stockings
Use of elastic stockings to alleviate patient symptoms
Placebo stockings
Placebo stocking with pressure applied to the legs

Locations

Country Name City State
Greece University Hospital of Patras Patras Achaia

Sponsors (1)

Lead Sponsor Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain/ache assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10) One week
Secondary revised Venous Clinical Severity Score (rVCSS) revised Venous Clinical Severity Score One week
Secondary Heaviness assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10) One week
Secondary Night cramps assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10) One week
Secondary Swelling sensation assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10) One week
Secondary Burning sensation assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10) One week
Secondary Paresthesia assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10) One week
Secondary Restless legs assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10) One week
Secondary throbbing assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10) One week
Secondary insomnia assessed using a visual analogue scale (0-10) Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10) One week
Secondary Ankle circumference This will be measured just above the malleoli, at the smallest point. One week