Varicosity
Conditions
Brief summary
Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings
Detailed 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.
Interventions
DEVICEElastic stockings
Use of elastic stockings to alleviate patient symptoms
DEVICEPlacebo stockings
Placebo stocking with pressure applied to the legs
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain/ache assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for dull pain of ache. This will be assessed using a visual analogue scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heaviness assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for heaviness. This will be assessed using a visual analogue scale (0-10) |
| Night cramps assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for night cramps. These will be assessed using a visual analogue scale (0-10) |
| Swelling sensation assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for sensation of swelling. This will be assessed using a visual analogue scale (0-10) |
| Burning sensation assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for burning sensation. This will be assessed using a visual analogue scale (0-10) |
| revised Venous Clinical Severity Score (rVCSS) | One week | revised Venous Clinical Severity Score |
| Restless legs assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for restless legs. This symptom will be assessed using a visual analogue scale (0-10) |
| throbbing assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for throbbing of their varicose veins. This will be assessed using a visual analogue scale (0-10) |
| insomnia assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for insomnia. This will be assessed using a visual analogue scale (0-10) |
| Ankle circumference | One week | This will be measured just above the malleoli, at the smallest point. |
| Paresthesia assessed using a visual analogue scale (0-10) | One week | Patients with varicose veins often complain for paresthesia. This will be assessed using a visual analogue scale (0-10) |
Countries
Greece
Contacts
Primary ContactStavros K Kakkos, MD, PhD, RVT
Outcome results
None listed