SOCKNLEG Compression Stocking Kit : User Friendliness (SOCKNLEGZH)

University of Zurich (UZH)

Status: Completed

Conditions: Venous Insufficiency of Leg

Treatments: Device: SIGVARIS Cotton; Device: SOCKNLEG

Study type: Interventional

Funder types: Other

Identifiers

NCT03429959

SL1725

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

SOCKNLEG

Experimental group

Description:

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

Treatment:

Device: SOCKNLEG

SIGVARIS Cotton

Active Comparator group

Description:

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

Treatment:

Device: SIGVARIS Cotton