Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms (MF)
Primary Purpose
Diabetes, Peripheral Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Magic Foot™
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes focused on measuring Foot Symptoms, Diabetes, Peripheral Vascular Disease, Magic Foot shoe
Eligibility Criteria
Inclusion Criteria:
- Subject over the age of 18 with Type 1 / Type 2 diabetes or with PVD (Peripheral vascular disease) or ABI < 0.9 with foot symptoms.
- Subject able and willing to comply with the requirements of the protocol.
- Subject able to understand and sign written informed consent to participate in the study.
One or more of the following foot symptoms:
- Pain at rest
- Pain on activity
- Nocturnal feet pain
- Burning sensations
- Loss of sensation
- Cold feet
- Recurrent ulcers , wounds , injuries - longtime to heal
Exclusion Criteria:
- Active foot infection
- Open ulcer in shoe area
- Subjects with unstable or lifethreatening conditions
- History of malignancy
- Active Charcot arthropathy
- Impaired cognitive function -unable to sign informed consent
- History of drug or alcohol abuse
- Subject currently enrolled or has not yet completed other investigational device or drug study or subject is receiving other investigational agents.
- Other conditions based on Principle Investigators judgement
Sites / Locations
- Gefen Cardiac Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magic foot shoe
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01784471
Brief Title
Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms
Acronym
MF
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yaffa Golan, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Peripheral Vascular Disease
Keywords
Foot Symptoms, Diabetes, Peripheral Vascular Disease, Magic Foot shoe
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magic foot shoe
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magic Foot™
Intervention Description
Magic Foot™ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled.
Primary Outcome Measure Information:
Title
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
Time Frame
From baseline to day 30.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject over the age of 18 with Type 1 / Type 2 diabetes or with PVD (Peripheral vascular disease) or ABI < 0.9 with foot symptoms.
Subject able and willing to comply with the requirements of the protocol.
Subject able to understand and sign written informed consent to participate in the study.
One or more of the following foot symptoms:
Pain at rest
Pain on activity
Nocturnal feet pain
Burning sensations
Loss of sensation
Cold feet
Recurrent ulcers , wounds , injuries - longtime to heal
Exclusion Criteria:
Active foot infection
Open ulcer in shoe area
Subjects with unstable or lifethreatening conditions
History of malignancy
Active Charcot arthropathy
Impaired cognitive function -unable to sign informed consent
History of drug or alcohol abuse
Subject currently enrolled or has not yet completed other investigational device or drug study or subject is receiving other investigational agents.
Other conditions based on Principle Investigators judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliezer Klainman, M.D.
Organizational Affiliation
Gefen Cardiac Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gefen Cardiac Health Center
City
Giv'atayim
ZIP/Postal Code
53583
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms
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