SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

Study Overview
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Brief Summary
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The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

Detailed Description
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The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Official Title
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SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: (Socknleg)To done of a novel compression system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers: age > 18 years, proband information read, consent form signed Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed. Exclusion Criteria: Active venous ulcer Peripheral arterial disease Peripheral neuropathy

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy subjects and patients<br>To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland. | Device: (Socknleg)To done of a novel compression system<br>* To done a novel compression system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donning success. | Ability to fully done the investigated compression devices. | Successful donning has to be completed within 5 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interface pressure | Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking. | Interface pressure is measured within 5 minutes of complete donning of the stocking. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compression therapy