SOCKNLEG Compression Stocking Kit : User Friendliness

NCT03429959 | Completed DMC

• 1 other identifier: SL1725
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

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

  through study completion, within 7 months

Secondary Outcomes (4)

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

  through study completion, within 7 months

• Patient evaluation of user friendliness

  3 days

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

  3 days

• Time needed to don and doff the two investigated leg compression

  3 days

Study Arms (2)

SOCKNLEG

EXPERIMENTAL

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

SIGVARIS Cotton

ACTIVE COMPARATOR

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

Interventions

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

SOCKNLEG

SIGVARIS Cotton DEVICE

SIGVARIS Cotton

SIGVARIS Cotton

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Dermatology, University Hospital of Zurich, Switzerland

Zurich, CH-8091, Switzerland

Location

Study Officials

• Juerg Hafner, Prof.

  Department of Dermatology, University Hospital Zurich, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: February 12, 2018
• Study Start: January 10, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)