Using mHealth to Modernize Diabetes Care (MDM)

Unity Health Toronto

Status: Unknown

Conditions: Diabetic Foot

Treatments: Device: MIMOSA Diagnostics

Study type: Observational

Funder types: Other

Identifiers

NCT03516474

17-365C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 4 patient groups

St. Michael's Hospital

Description:

St. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100

Treatment:

Device: MIMOSA Diagnostics

South Riverdale Community Health Centre

Description:

South Riverdale is a Community Health Centre focused on prevention. n=100

Treatment:

Device: MIMOSA Diagnostics

Westpark

Description:

Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100

Treatment:

Device: MIMOSA Diagnostics

Women's College Hospital

Description:

Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100

Treatment:

Device: MIMOSA Diagnostics