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| Name | Class |
|---|---|
| South Riverdale Community Health Centre | UNKNOWN |
| West Park Healthcare Centre | OTHER |
| Women's College Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| St. Michael's Hospital | St. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100 |
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| South Riverdale Community Health Centre | South Riverdale is a Community Health Centre focused on prevention. n=100 |
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| Westpark | Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100 |
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| Women's College Hospital | Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIMOSA Diagnostics | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Cross, MD, PhD | Contact | 416-864-6060 | 77393 | crosska@smh.ca |
| Julie Perry, MSc, PhD | Contact | 416-864-6060 | 77393 | perryj@smh.ca |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23294922 | Background | 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. | |
| 26248037 | Background | 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. |
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All personal health information given will be anonymized when it is collected: a master linking log will link potentially identifiable characteristics to a specific study ID number listed in the app, to be held only by the Principal Investigator under lock or encryption and password protection. Study data seen by research assistants and data analysts will be strictly anonymized, encrypted, password protected, and stored in a locked research lab, separately from the master linking log.
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 28942581 | Background | 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. |
| 17537120 | Background | 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. |
| 26852680 | Background | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |