Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who completely don the two investigated leg compression devices | through study completion, within 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who completely doff the two investigated leg compression devices | through study completion, within 7 months | |
| Patient evaluation of user friendliness | Evaluation of user friendliness using the ICC compression questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juerg Hafner, Prof. | Department of Dermatology, University Hospital Zurich, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, University Hospital of Zurich, Switzerland | Zurich | CH-8091 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SIGVARIS Cotton | Device | SIGVARIS Cotton |
|
| 3 days |
| 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 |
| 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 |