Using mHealth to Modernize Diabetes Care

• Conditions: Diabetic Foot
• Interventions: Device: MIMOSA Diagnostics

• Registration Number: NCT03516474
• Lead Sponsor: Unity Health Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-08
• Status Verified: 2018-04
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study First Posted: 2018-05-04
• Last Update Posted: 2018-05-04
• Study Start: 2018-05-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Diabetes: Type I or Type II.
2. Outpatient or inpatient
3. Diabetic Foot Ulcer
4. Adhere to monitoring schedule

Exclusion Criteria

1. Presence of invasive infection requiring intravenous antibiotics
2. Cognitively able to give consent & participate in study
3. Active malignancy
4. End stage renal disease
5. Patients who are participating in another clinical study for ulcer management
6. Patients with a known history of poor compliance with medical treatment
7. Patients who are unable to understand the aims of the study and not give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
St. Michael's Hospital	MIMOSA Diagnostics	St. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100
Women's College Hospital	MIMOSA Diagnostics	Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100
Westpark	MIMOSA Diagnostics	Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100
South Riverdale Community Health Centre	MIMOSA Diagnostics	South Riverdale is a Community Health Centre focused on prevention. n=100

Primary Outcome Measures

Name	Time	Method
Lower rates of DFU recurrence in patients monitored using mHealth	0-12 months	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.