Venous Insufficiency of Leg
Conditions
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.
Interventions
DEVICESOCKNLEG
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
DEVICESIGVARIS Cotton
SIGVARIS Cotton
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who completely don the two investigated leg compression devices | through study completion, within 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Evaluation of user friendliness using the ICC compression questionnaire |
| Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2. | 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) |
| Time needed to don and doff the two investigated leg compression | 3 days | Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator |
Countries
Switzerland
Outcome results
None listed