Back to resultsSocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device (Socknleg)
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
(Socknleg)To done of a novel compression system
Sponsored by
About this trial
This is an interventional prevention trial for Venous Insufficiency focused on measuring Compression therapy
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers: age > 18 years, proband information read, consent form signed
- Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed.
Exclusion Criteria:
- Active venous ulcer
- Peripheral arterial disease
- Peripheral neuropathy
Sites / Locations
- Department of Dermatology, University Hospital of Zurich, Switzerland
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Healthy subjects and patients
Arm Description
To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.
Outcomes
Primary Outcome Measures
Donning success.
Ability to fully done the investigated compression devices.
Secondary Outcome Measures
Interface pressure
Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02621632
Brief Title
SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Acronym
Socknleg
Official Title
SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.
Detailed Description
The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Compression therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects and patients
Arm Type
Other
Arm Description
To done a novel compression system. 20 healthy subjects and 20 patients done a novel compression system termed Socknleg and a compression class III stocking as a comparator.The Socknleg compression system was developed by the investigator and produced by Sigvaris AG, St. Gallen, Switzerland.
Intervention Type
Device
Intervention Name(s)
(Socknleg)To done of a novel compression system
Intervention Description
To done a novel compression system.
Primary Outcome Measure Information:
Title
Donning success.
Description
Ability to fully done the investigated compression devices.
Time Frame
Successful donning has to be completed within 5 minutes.
Secondary Outcome Measure Information:
Title
Interface pressure
Description
Interface pressure of the compression systems is measured at level cB1 (transition of the Achilles tendon to the calf muscle) in mmHg by a pressure measuring device termed Picopress® . Interface pressure is compared between the novel compression system and the comparator, a class III compression stocking.
Time Frame
Interface pressure is measured within 5 minutes of complete donning of the stocking.
10. Eligibility
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers: age > 18 years, proband information read, consent form signed
Patients: age > 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age > 18 year, patient information read, consent signed.
Exclusion Criteria:
Active venous ulcer
Peripheral arterial disease
Peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juerg Hafner, Prof. (MD)
Organizational Affiliation
University of Zurich
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
Learn more about this trial
SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
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