Clinical trial NCT03516474: Using mHealth to Modernize Diabetes Care
Official title: Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot
Keywords: nir
diabetes
diabetic foot ulcer (DFU).
wound
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: South Riverdale Community Health Centre
name: West Park Healthcare Centre
name: Women's College Hospital
First posted: 2018-05-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult diabetic subjects will be identified as candidates for our study if they present to the outpatient clinic, emergency department, inpatient or wound care team with or without a DFU. A subject is considered a patient with a DFU on one foot. If the patient has 2 wounds on the same foot, they are still considered one subject and both wounds are imaged. If the subject has a wound on the opposite foot they are considered a new subject.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower rates of DFU recurrence in patients monitored using mHealth
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pelletier C, Dai S, Roberts KC, Bienek A, Onysko J, Pelletier L. Report summary. Diabetes in Canada: facts and figures from a public health perspective. Chronic Dis Inj Can. 2012 Dec;33(1):53-4.
citation: Skrepnek GH, Mills JL Sr, Armstrong DG. A Diabetic Emergency One Million Feet Long: Disparities and Burdens of Illness among Diabetic Foot Ulcer Cases within Emergency Departments in the United States, 2006-2010. PLoS One. 2015 Aug 6;10(8):e0134914. doi: 10.1371/journal.pone.0134914. eCollection 2015.
citation: Serrano V, Spencer-Bonilla G, Boehmer KR, Montori VM. Minimally Disruptive Medicine for Patients with Diabetes. Curr Diab Rep. 2017 Sep 23;17(11):104. doi: 10.1007/s11892-017-0935-7.
citation: Cross KM, Leonardi L, Payette JR, Gomez M, Levasseur MA, Schattka BJ, Sowa MG, Fish JS. Clinical utilization of near-infrared spectroscopy devices for burn depth assessment. Wound Repair Regen. 2007 May-Jun;15(3):332-40. doi: 10.1111/j.1524-475X.2007.00235.x.
citation: Vashist SK, Schneider EM, Luong JH. Commercial Smartphone-Based Devices and Smart Applications for Personalized Healthcare Monitoring and Management. Diagnostics (Basel). 2014 Aug 18;4(3):104-28. doi: 10.3390/diagnostics4030104.