SOCKNLEG Compression Stocking Kit : User Friendliness

Venous Insufficiency of Leg Clinical Trial

— SOCKNLEGZH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429959
• Other study ID #: SL1725
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

Device:
• 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
• SIGVARIS Cotton
SIGVARIS Cotton

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital of Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who completely don the two investigated leg compression devices		through study completion, within 7 months
Secondary	Number of patients who completely doff the two investigated leg compression devices		through study completion, within 7 months
Secondary	Patient evaluation of user friendliness	Evaluation of user friendliness using the ICC compression questionnaire	3 days
Secondary	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
Secondary	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