NCT03516474

Using mHealth to Modernize Diabetes Care

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
DEVICE	MIMOSA Diagnostics	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.

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-05-04
• Last updated: 2018-05-04