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Completed

NCT Number: NCT03429959

SOCKNLEG Compression Stocking Kit : User Friendliness

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.

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Key information

Conditions

Venous Insufficiency of Leg

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOCKNLEG

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

Device

SIGVARIS Cotton

Primary outcomes

  1. Number of patients who completely don the two investigated leg compression devices

    Time frame: through study completion, within 7 months

Secondary outcomes

  1. Number of patients who completely doff the two investigated leg compression devices

    Time frame: through study completion, within 7 months

  2. Patient evaluation of user friendliness

    Time frame: 3 days

    Evaluation of user friendliness using the ICC compression questionnaire

  3. Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.

    Time frame: 3 days

    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)

  4. Time needed to don and doff the two investigated leg compression

    Time frame: 3 days

    Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: SOCKNLEGZH

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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