Using mHealth to Modernize Diabetes Care

Study Overview
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Brief Summary
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In this study the investigators are testing a device that may help us tell how well the participants' wound is healing. This device is called the MIMOSA, and it shines different colours of light on the participants' skin. It will not touch the participants' skin, or change how the participants' wound is healing. The MIMOSA is designed to be used alongside the camera that is built into the participants' cell phone, and the investigators will use a cell phone to take a picture of the participants' skin. This picture will tell us how much oxygen is getting to the participants' wound, which can tell us more about how the participants are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how the participants' wound is healing.

Detailed Description
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The investigators have developed a tool called the MultIspectral MObile TiSsue Assessment (MIMOSA) Device, which attaches to a smartphone and assesses tissue health parameters in a quick, non-invasive way using near-infrared light. This study will use MIMOSA to monitor patients at 4 sites in Toronto (St. Michael's Hospital, Women's College Hospital, South Riverdale Community Health Centre and at Westpark Healthcare Centre). These study sites were chosen to cover patients from diverse clinical backgrounds: St. Michael's Hospital is an Acute care centre for the diabetic lower extremity, Women's College Hospital is an outpatient wound clinic focused on the management of DFUs, South Riverdale is a Community Health Centre focused on prevention, and Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. conducted on patients who present with a non-healing diabetic foot ulcer and are already receiving standard best practice as prescribed by the diabetic foot multi-disciplinary team.

Official Title
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Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: MIMOSA Diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes: Type I or Type II. Outpatient or inpatient Diabetic Foot Ulcer Adhere to monitoring schedule Exclusion Criteria: Presence of invasive infection requiring intravenous antibiotics Cognitively able to give consent & participate in study Active malignancy End stage renal disease Patients who are participating in another clinical study for ulcer management Patients with a known history of poor compliance with medical treatment Patients who are unable to understand the aims of the study and not give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| St. Michael's Hospital<br>St. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100 | Device: MIMOSA Diagnostics<br>* The MIMOSA shines different colours of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing.<br>* Other names: MIMOSA;|
| South Riverdale Community Health Centre<br>South Riverdale is a Community Health Centre focused on prevention. n=100 | Device: MIMOSA Diagnostics<br>* The MIMOSA shines different colours of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing.<br>* Other names: MIMOSA;|
| Westpark<br>Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100 | Device: MIMOSA Diagnostics<br>* The MIMOSA shines different colours of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing.<br>* Other names: MIMOSA;|
| Women's College Hospital<br>Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100 | Device: MIMOSA Diagnostics<br>* The MIMOSA shines different colours of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing.<br>* Other names: MIMOSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower rates of DFU recurrence in patients monitored using mHealth | Accurately recorded pictures and information will help clinicians to accurately access patient foot health and hopefully reduce the frequency of DFU's using this information. | 0-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nir, diabetes, diabetic foot ulcer (DFU)., wound