Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Footâ„¢.
If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.
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 Footâ„¢ to use at home.
Magic Footâ„¢ 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 Footâ„¢. 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 Footâ„¢ will remain with the subjects. In consultation with the treating physician a decision will be made whether to continue with treatment or not.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magic foot shoe | Experimental | Magic Footâ„¢ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magic Footâ„¢ | Device | Magic Footâ„¢ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total peripheral resistance as assessed by impedance cardiography (ICG) from baseline to day 30 | From baseline to day 30. |
Not provided
Not provided
Inclusion Criteria:
One or more of the following foot symptoms:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eliezer Klainman, M.D. | Gefen Cardiac Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gefen Cardiac Health Center | Giv‘atayim | 53583 | Israel |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |