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Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms (MF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784471
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Yaffa Golan, Ltd.

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.

Condition or disease Intervention/treatment Phase
Diabetes Peripheral Vascular Disease Device: Magic Foot™ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 14, 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30 [ Time Frame: From baseline to day 30. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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.
  2. Subject able and willing to comply with the requirements of the protocol.
  3. 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:

  1. Active foot infection
  2. Open ulcer in shoe area
  3. Subjects with unstable or lifethreatening conditions
  4. History of malignancy
  5. Active Charcot arthropathy
  6. Impaired cognitive function -unable to sign informed consent
  7. History of drug or alcohol abuse
  8. Subject currently enrolled or has not yet completed other investigational device or drug study or subject is receiving other investigational agents.
  9. Other conditions based on Principle Investigators judgement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784471

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Gefen Cardiac Health Center
Giv`atayim, Israel, 53583
Sponsors and Collaborators
Yaffa Golan, Ltd.
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Principal Investigator: Eliezer Klainman, M.D. Gefen Cardiac Health

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Responsible Party: Yaffa Golan, Ltd. Identifier: NCT01784471    
Other Study ID Numbers: MF-1
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Yaffa Golan, Ltd.:
Foot Symptoms
Peripheral Vascular Disease
Magic Foot shoe
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases