Clinical trial NCT03429959: SOCKNLEG Compression Stocking Kit : User Friendliness
Official title: SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency of Leg
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who completely don the two investigated leg compression devices
timeFrame: through study completion, within 7 months
Secondary outcomes:
measure: Number of patients who completely doff the two investigated leg compression devices
timeFrame: through study completion, within 7 months
measure: Patient evaluation of user friendliness
timeFrame: 3 days
measure: Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
timeFrame: 3 days
measure: Time needed to don and doff the two investigated leg compression
timeFrame: 3 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich, Switzerland
Study officials:
affiliation: Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
name: Juerg Hafner, Prof.
role: PRINCIPAL_INVESTIGATOR
References: