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Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic stockings | Active Comparator | Class 1 elastic stockings (18-21 mmHg) |
|
| Placebo stockings | Placebo Comparator | Placebo stockings (0 mmHg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic stockings | Device | Use of elastic stockings to alleviate patient symptoms |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| revised Venous Clinical Severity Score (rVCSS) | revised Venous Clinical Severity Score | One week |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stavros K Kakkos, MD, PhD, RVT | Contact | 302613603406 | kakkos@upatras.gr |
| Name | Affiliation | Role |
|---|---|---|
| Stavros K Kakkos, MD, PhD | University of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Recruiting | Pátrai | Achaia | 26504 | Greece |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 24, 2017 | |
| Reset | Jul 27, 2018 | |
| Release | Jul 30, 2018 | |
| Reset | Jan 15, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 24, 2017 | Jul 27, 2018 | |||
| Jul 30, 2018 |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053828 | Stockings, Compression |
| ID | Term |
|---|---|
| D058128 | Compression Bandages |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| Placebo stockings |
| Device |
Placebo stocking with pressure applied to the legs |
|
| One week |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Ankle circumference | This will be measured just above the malleoli, at the smallest point. | One week |
| Jan 15, 2019 |