Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In Canada, the age-standardized prevalence of diabetes is on the rise (increasing from 3.3% in 1998/99 to 5.6% in 2008/2009 Public Health Agency of Canada (July 2011)) and is almost 1 in 10 globally. One of the most devastating complications of diabetes is the loss of a limb, (also known as lower extremity amputation, or LEA) due to complications resulting from a diabetic foot ulcer (DFU). Diabetics have a lifetime risk of 15-25% of developing a DFU1, which can lead to significant decreases in the quality of life, limitations in mobility, function and independence, and increased chance of depression and anxiety. In addition, diabetics post-LEA have high rates of mortality, with 30% dying in the first year post LEA and 70% at 5 years (more than the lifetime risk of dying from cancers). What differentiates a DFU that heals and one that progresses to LEA is often the vascularity of the limb; the diabetic lower extremity often becomes ischemic due to the vascular sequelae that are a common complication of diabetes, which hampers wound closure and immune clearance of wound-associated infections. Understanding limb oxygenation can direct treatment of a DFU, which may require limb revascularization to heal.
The MultIspectral MObile tiSsue Assessment (MIMOSA) Imager acquires digital images to calculate anatomical details of chronic wounds (e.g. diameter, surface area, and perimeter). The device can be worn from a lanyard, and clips onto a smartphone, using natural ambient lighting to capture images of a wound. The MIMOSA also uses up to 6 near-infrared LEDs to illuminate tissue with different wavelengths of light to assess tissue oxygenation.
The Food and Drug Administration (FDA) has previously approved a near-infrared device called the Kent camera for the assessment of tissue oxygenation. The goal of this proposal is to assess tissue oxygenation in a group of healthy volunteers with both the MIMOSA near-infrared imaging device and the Kent Camera.
The investigators hope to show that the MIMOSA Imager is substantially equivalent to the Kent Camera, and as such, the investigators are modeling the investigator's experiments on data previously published by the makers of the Kent Camera. The MIMOSA Imager is a contact-less device, and differs from the Kent Camera only in that it is smaller and more portable.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIMOSA Imager | Device | The MultIspectral MObile tiSsue Assessment (MIMOSA) Imager acquires digital images to calculate anatomical details of chronic wounds (e.g. diameter, surface area, and perimeter). The device can be worn from a lanyard, and clips onto a smartphone, using natural ambient lighting to capture images of a wound. The MIMOSA also uses up to 6 near-infrared LEDs to illuminate tissue with different wavelengths of light to assess tissue oxygenation. | ||
| Kent Camera | Device | The Food and Drug Administration (FDA) has previously approved a near-infrared device called the Kent camera for the assessment of tissue oxygenation. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue oxygenation is detected on both the MIMOSA Imager and Kent camera. | The MIMOSA Imager and Kent camera can both detect similar levels of tissue oxygenation. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Age (years) 26 ± 3 (22-33) Gender (male/female) 6/6 Height (m) 1.70 ± 0.10 (1.56-1.83) Weight (kg) 65 ± 11 (49-79) Body mass index (kg/m2) 22 ± 2 (20-26) Systolic pressure (mmHg) 115 ± 15 (83-138) Diastolic pressure (mmHg) 73 ± 10 (59-91)
Exclusion Criteria:
Not provided
Not provided
Healthy volunteers will be recruited at St. Michael's Hospital including staff. The following inclusion criteria will be strictly followed:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Cross, MD, PhD | Contact | 416-864-6060 | 77393 | crosska@smh.ca |
| Julie Perry, PhD, MSc | Contact | 416-864-6060 | 77393 | perryj@smh.ca |
Not provided
Not provided
| 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. | |
| Background | V. Hartwig, M. Marinelli, F. Rocco, and A. L'Abbate, "Assessment of Microvascular Function Using Near-Infrared Spectroscopic 2D Imaging of Whole Hand Combined with Vascular Occlusion Test," J. Med. Biol. Eng., vol. 36, no. 1, pp. 87-95, Feb. 2016. | ||
| 26248037 |
Not provided
Not provided
TBD upon REB review.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. |
| 30515351 | Background | Leung G, Duta D, Perry J, Leonardi L, Fish J, Cross K. Rapid tissue viability evaluation using methemoglobin as a biomarker in burns. Int J Burns Trauma. 2018 Oct 20;8(5):126-134. eCollection 2018. |
| 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. |
| 19287258 | Background | Corser W, Xu Y. Facilitating patients' diabetes self-management: a primary care intervention framework. J Nurs Care Qual. 2009 Apr-Jun;24(2):172-8. doi: 10.1097/01.NCQ.0000347456.59289.22. |
| 27869655 | Background | Griffith ML, Siminerio L, Payne T, Krall J. A Shared Decision-Making Approach to Telemedicine: Engaging Rural Patients in Glycemic Management. J Clin Med. 2016 Nov 17;5(11):103. doi: 10.3390/jcm5110103. |
| 28249834 | Background | Bonoto BC, de Araujo VE, Godoi IP, de Lemos LL, Godman B, Bennie M, Diniz LM, Junior AA. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2017 Mar 1;5(3):e4. doi: 10.2196/mhealth.6309. |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |