Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms (MF)
This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated with the Magic Foot™.
If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study to Assess the Use of the Magic Foot in the Improvement of Subjective and Objective Parameters in Subjects With Foot Symptoms as a Result of Diabetes or Peripheral Vascular Disease.|
- Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30 [ Time Frame: From baseline to day 30. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Magic foot shoe
Magic Foot™ will be dispensed to all subjects. Shoes will be activated at the clinic for 30 minutes. Subjects will self-use and activate the shoes at home daily for 30 days.
Device: Magic Foot™
Magic Foot™ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled.
Other Name: Magic Foot™
This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened and enrolled. Subjects meeting inclusion criteria will sign informed consent. They will undergo a full examination including blood pressure measurement, heart rate and ECG.
A self evaluation questionnaire relating to foot and sleep disorder symptoms will be completed.
A baseline screening ICG will be performed to measure total peripheral resistance CO (Cardiac Output) and SV (Stroke Volume).
ABI will be performed. The investigational product will be used for 30 minutes and ICG will be repeated.
Each subject will be provided with a size appropriate pair of Magic Foot™ to use at home.
Magic Foot™ will be used for thirty minutes daily for 30 days. This will be done at rest in the evening prior to bedtime. A diary to report compliance will be provided to the subjects. The subject will provide the completed diary to the site staff at day 14 and day 30. Subjects will be reassessed at Day 14. Self evaluation questionnaire will be completed. Subjects will continue with daily use of Magic Foot™. Subject will be reassessed at day 30. ICG, ABI (Ankle Bracial Index) and a final self assessment questionnaire will be repeated at day 30.
At the end of the study the Magic Foot™ will remain with the subjects. In consultation with the treating physician a decision will be made whether to continue with treatment or not.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784471
|Gefen Cardiac Health Center||Recruiting|
|Giv`atayim, Israel, 53583|
|Contact: Shlomit Pasternak firstname.lastname@example.org|
|Principal Investigator: Eliezer Klainman, Prof.|
|Principal Investigator:||Eliezer Klainman, M.D.||Gefen Cardiac Health|