SOCKNLEG Compression Stocking Kit: Physical Properties (SOCKNLEGLCA)
Primary Purpose
Venous Insufficiency of Leg
Status
Unknown status
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 post-menopausal women over the age of 65
- Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
- Indication of a compression therapy by medical compression stocking
Exclusion Criteria:
- Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index <0.8 or >1.3
- Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
- Advanced heart insufficiency (NYHA III-IV)
- Contraindications to compression therapy
- Known allergies to any components of the stocking material
- Inability to follow the procedures of the study
Sites / Locations
- Department of Dermatology, University Hospital of Zurich, SwitzerlandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SOCKNLEG
Sigvaris COTTON
Arm Description
Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings. All examinations will be conducted in all participants and with both stockings one after the other.
Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings. All examinations will be conducted in all participants and with both stockings one after the other.
Outcomes
Primary Outcome Measures
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.
Secondary Outcome Measures
Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg
Comparing the SSI at point cC of both stockings with each other and with the standard SSI values at point cB1. The point cC is a new measuring point at the largest circumference of the calf.
Dynamic Stiffness Index (DSI) values of both stockings in mmHg
The DSI is a substraction of the Interface Pressures measured at each point (cC and cB1) on the leg during wiping of the foot while wearing a compression stocking. Measuring instruments are again the pressure probes.
Venous ejection fraction (VEF) of both stockings in %
Non-invasive measurement of the venous filling volumes of the leg with a strain gauge plethysmography the Angioflow2 (Microlabitalia, Padua, Italy).
Interface Pressures at point cB on the leg in mmHg
The point cB is the point of the smallest circumference of the leg and is the standard measuring point for compression strength of a leg compression stocking. Measured with a pressure probe on the leg of the study participant under the compression stocking.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03743597
Brief Title
SOCKNLEG Compression Stocking Kit: Physical Properties
Acronym
SOCKNLEGLCA
Official Title
SOCKNLEG Leg Compression Stocking Kit: Physical Properties: Static Stiffness Index - Venous Ejection Fraction An Open Monocentric Randomized Controlled Cross-over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
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
This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.
The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.
In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.
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
Model Description
A computer generated list will allocate each participant to either one of the stockings, the innovative SOCKNLEG, or the standard Sigvaris COTTON stocking. In each participant the examinations will be conducted with both stockings.
The allocated group defines with which stocking the examinations will be conducted first.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOCKNLEG
Arm Type
Experimental
Arm Description
Group of participant who will conduct the examinations first with the SOCKNLEG compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
Arm Title
Sigvaris COTTON
Arm Type
Active Comparator
Arm Description
Group of participant who will conduct the examinations first with the Sigvaris COTTON compression stockings.
All examinations will be conducted in all participants and with both stockings one after the other.
Intervention Type
Device
Intervention Name(s)
SOCKNLEG
Intervention Description
Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
In each participant all examinations will be performed with both study stockings, one after the other
Intervention Type
Device
Intervention Name(s)
Sigvaris COTTON
Intervention Description
Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
In each participant all examinations will be performed with both study stockings, one after the other
Primary Outcome Measure Information:
Title
Static Stiffness Index (SSI) values of both stockings in mmHg measured at point cB1 on the leg
Description
The SSI is a substraction of the Interface Pressures measured with a pressure probe on the leg of the study participant in standing and in supine position while wearing a compression stocking. The point cB1 is a thereby a standard measuring point at the distal insertion of the gastrocnemius muscle of the leg.
Time Frame
1 day, during study visit
Secondary Outcome Measure Information:
Title
Static Stiffness Index (SSI) values of both stocking in mmHg measured at point cC on the leg
Description
Comparing the SSI at point cC of both stockings with each other and with the standard SSI values at point cB1. The point cC is a new measuring point at the largest circumference of the calf.
Time Frame
1 day, during study visit
Title
Dynamic Stiffness Index (DSI) values of both stockings in mmHg
Description
The DSI is a substraction of the Interface Pressures measured at each point (cC and cB1) on the leg during wiping of the foot while wearing a compression stocking. Measuring instruments are again the pressure probes.
Time Frame
1 day, during study visit
Title
Venous ejection fraction (VEF) of both stockings in %
Description
Non-invasive measurement of the venous filling volumes of the leg with a strain gauge plethysmography the Angioflow2 (Microlabitalia, Padua, Italy).
Time Frame
1 day, during study visit
Title
Interface Pressures at point cB on the leg in mmHg
Description
The point cB is the point of the smallest circumference of the leg and is the standard measuring point for compression strength of a leg compression stocking. Measured with a pressure probe on the leg of the study participant under the compression stocking.
Time Frame
1 day, during study visit
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 post-menopausal women over the age of 65
Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
Indication of a compression therapy by medical compression stocking
Exclusion Criteria:
Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index <0.8 or >1.3
Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
Advanced heart insufficiency (NYHA III-IV)
Contraindications to compression therapy
Known allergies to any components of the stocking material
Inability to follow the procedures of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juerg Hafner, M.D. Prof.
Phone
+41442552533
Email
juerg.hafner@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline S Buset, M.D.
Phone
+41442551111
Email
caroline.buset@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, M.D. 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, M.D. Prof.
Phone
+41 44 255 25 33
Email
juerg.hafner@usz.ch
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, M.D. Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SOCKNLEG Compression Stocking Kit: Physical Properties
We'll reach out to this number within 24 hrs