SOCKNLEG Compression Stocking Kit : User Friendliness (SOCKNLEGZH)
Primary Purpose
Venous Insufficiency of Leg
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SOCKNLEG
SIGVARIS Cotton
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency of Leg
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
Sites / Locations
- Department of Dermatology, University Hospital of Zurich, Switzerland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOCKNLEG
SIGVARIS Cotton
Arm Description
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
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
Outcomes
Primary Outcome Measures
Number of patients who completely don the two investigated leg compression devices
Secondary Outcome Measures
Number of patients who completely doff the two investigated leg compression devices
Patient evaluation of user friendliness
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.
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
Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429959
Brief Title
SOCKNLEG Compression Stocking Kit : User Friendliness
Acronym
SOCKNLEGZH
Official Title
SOCKNLEG Compression Stocking Kit User Friendliness: Donning-Doffing-Edema Prevention An Open Monocentric Randomized Controlled Cross-over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency of Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOCKNLEG
Arm Type
Experimental
Arm Description
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
Arm Title
SIGVARIS Cotton
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
SOCKNLEG
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
SIGVARIS Cotton
Intervention Description
SIGVARIS Cotton
Primary Outcome Measure Information:
Title
Number of patients who completely don the two investigated leg compression devices
Time Frame
through study completion, within 7 months
Secondary Outcome Measure Information:
Title
Number of patients who completely doff the two investigated leg compression devices
Time Frame
through study completion, within 7 months
Title
Patient evaluation of user friendliness
Description
Evaluation of user friendliness using the ICC compression questionnaire
Time Frame
3 days
Title
Measuring oedema prevention of the compression stockings by comparison of leg volume measurement at V4 to V3 and V4 to V2.
Description
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 Frame
3 days
Title
Time needed to don and doff the two investigated leg compression
Description
Time in minutes and seconds needed to don and doff each study stocking, measured by study investigator
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, Prof.
Organizational Affiliation
Department of Dermatology, University Hospital Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University Hospital of Zurich, Switzerland
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SOCKNLEG Compression Stocking Kit : User Friendliness
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