SOCKNLEG Compression Stocking Kit : User Friendliness

Study Overview
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Brief Summary
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The investigators aim to evaluate the user friendliness of a newly designed leg compression stocking kit, the SOCKNLEG, compared to a standard leg compression stocking of the same compression strength, the SIGVARIS Cotton. The SOCKNLEG is not yet commercially available, whereas the SIGVARIS Cotton has been successfully commercialized for many years. After an initial screening visit, a computer generated list will allocate the participants in either the SOCKNLEG or the SIGVARIS Cotton group. All participants will try on both study stockings, in the order of their allocated group, and will rate their donning and doffing success with a questionnaire. The patients will then wear only the assigned study stocking of their allocated group, for a day and rate its comfort again at the end of the day. The donning and doffing success will also be rated by the study investigator. Leg volume measurements of the study leg will be taken at each visit to determine edema prevention.

Official Title
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SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial

Conditions
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Venous Insufficiency of Leg

Intervention / Treatment
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* Device: SOCKNLEG
* Device: SIGVARIS Cotton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature Male or postmenopausal female patient, aged over 65 years of age Diagnosed venous insufficiency stage C3-C6 (according to CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) -classification for venous diseases) Exclusion Criteria: Venous leg ulcer with a surface >5cm2 Peripheral artery disease (PAD) or media calcinosis (Ankle-Brachial-Index <0.8 or >1.3) Difference in brachial blood pressure >20mmHg in both arms Suspected polyneuropathy with ≥4 sensible test areas, measured with the Semmes-Weinstein-Monofilament-Test Inability to reach the forefoot with their hands Inability to follow the procedures of the study Bed-ridden hospitalized patients who are not able to leave the bed or sit upright for a few consecutive hours

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOCKNLEG<br>Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg | Device: SOCKNLEG<br>* Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking<br>|
| Active Comparator: SIGVARIS Cotton<br>Donning and doffing success of the study stocking compared with both stockings, wearing of the study stocking for a day, standardized non invasive measurement to calculate leg volume of the study leg | Device: SIGVARIS Cotton<br>* SIGVARIS Cotton<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who completely don the two investigated leg compression devices |  | through study completion, within 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who completely doff the two investigated leg compression devices |  | through study completion, within 7 months | 
| Patient evaluation of user friendliness | Evaluation of user friendliness using the ICC compression questionnaire | 3 days | 
| Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2. | Assessment by measuring leg volume at the morning visit 3, compared to leg volume at the evening visit 4 and by comparing the leg volumes of visit 4 (compression) to visit 2 (no compression for 1 day) | 3 days | 
| Time needed to don and doff the two investigated leg compression | Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator | 3 days |