SOCKNLEG Compression Stocking Kit : User Friendliness

NCT ID: NCT03429959

Last Updated: 2019-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-06-30

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.

Detailed Description

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Conditions

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Venous Insufficiency of Leg

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOCKNLEG

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

Group Type EXPERIMENTAL

SOCKNLEG

Intervention Type DEVICE

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

SIGVARIS Cotton

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

Group Type ACTIVE_COMPARATOR

SIGVARIS Cotton

Intervention Type DEVICE

SIGVARIS Cotton

Interventions

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SOCKNLEG

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

Intervention Type DEVICE

SIGVARIS Cotton

SIGVARIS Cotton

Intervention Type DEVICE

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juerg Hafner, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

Locations

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Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SL1725

Identifier Type: -

Identifier Source: org_study_id

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