DiabetesMFNCT01784471
Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms
A study testing Magic Foot™ in people with Diabetes and Peripheral Vascular Disease, run by Yaffa Golan, Ltd. at 1 site in Israel.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Peripheral Vascular Disease
- What is being tested?
- Magic Foot™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to 14 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Nocturnal feet pain
- Burning sensations
- Loss of sensation
- Cold feet
- Recurrent ulcers , wounds , injuries - longtime to heal
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes, Peripheral Vascular Disease
- Being tested
- Magic Foot™
- Keywords
- Foot Symptoms, Diabetes, Peripheral Vascular Disease, Magic Foot shoe
- Medical subject headings
- Diabetes Mellitus, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magic Foot™Device
Magic Foot™ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled.
| Study group | Role | What they receive |
|---|---|---|
| Magic foot shoe | Experimental | 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. Receives: Device: Magic Foot™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
Measured: From baseline to day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2013
- Study completion14 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaffa Golan, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliezer Klainman, M.D., Principal investigator, Gefen Cardiac Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784471
- Sponsor's protocol ID
- MF-1
- Acronym
- MF
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2013
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01784471
- Acronym / sponsor ID
- MF / MF-1
- Conditions
- Diabetes, Peripheral Vascular Disease
- Keywords
- Foot Symptoms, Diabetes, Peripheral Vascular Disease, Magic Foot shoe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yaffa Golan, Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- 14 Mar 2013 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magic foot shoe | Experimental | Device: Magic Foot™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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Pain at rest
- Pain on activity
Key exclusion criteria (9 listed)
- Active foot infection
- Open ulcer in shoe area
- Subjects with unstable or lifethreatening conditions
- History of malignancy
- Active Charcot arthropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magic Foot™Magic Foot™ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled. | Device | Magic foot shoe |
Primary outcome
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30
Time frame: From baseline to day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliezer Klainman, M.D. principal investigator
Gefen Cardiac Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magic Foot™ in people with Diabetes and Peripheral Vascular Disease, run by Yaffa Golan, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30 (time frame: From baseline to day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.