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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Yaffa Golan, Ltd.
Sponsor:
Information provided by (Responsible Party):
Yaffa Golan, Ltd.
ClinicalTrials.gov Identifier:
NCT01784471
First received: January 30, 2013
Last updated: February 3, 2013
Last verified: February 2013
  Purpose

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 Intervention
Diabetes
Peripheral Vascular Disease
Device: Magic Foot

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Yaffa Golan, Ltd.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784471

Locations
Israel
Gefen Cardiac Health Center Recruiting
Giv`atayim, Israel, 53583
Contact: Shlomit Pasternak       tzionalela@gmail.com   
Principal Investigator: Eliezer Klainman, Prof.         
Sponsors and Collaborators
Yaffa Golan, Ltd.
Investigators
Principal Investigator: Eliezer Klainman, M.D. Gefen Cardiac Health
  More Information

No publications provided

Responsible Party: Yaffa Golan, Ltd.
ClinicalTrials.gov Identifier: NCT01784471     History of Changes
Other Study ID Numbers: MF-1
Study First Received: January 30, 2013
Last Updated: February 3, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Yaffa Golan, Ltd.:
Foot Symptoms
Diabetes
Peripheral Vascular Disease
Magic Foot shoe

Additional relevant MeSH terms:
Diabetes Mellitus
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 20, 2014