Using mHealth to Modernize Diabetes Care

Diabetic Foot Clinical Trial

— MDM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03516474
• Other study ID #: 17-365C
• Status: Not yet recruiting
• Start date: May 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: Karen Cross, MD, PhD
• Phone: 416-864-6060
• Email: crosska[@]smh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	South Riverdale Community Health Centre, West Park Healthcare Centre, Women's College Hospital

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Patient smartphone use