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Trial record 2 of 6 for:    SHINE Trauma

Using mHealth to Modernize Diabetes Care (MDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516474
Recruitment Status : Unknown
Verified April 2018 by St. Michael's Hospital, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
South Riverdale Community Health Centre
West Park Healthcare Centre
Women's College Hospital
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment
Diabetic Foot Device: MIMOSA Diagnostics

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
St. Michael's Hospital

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

n=100

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.
Other Name: MIMOSA

South Riverdale Community Health Centre
South Riverdale is a Community Health Centre focused on prevention. n=100
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.
Other Name: MIMOSA

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

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




Primary Outcome Measures :
  1. Lower rates of DFU recurrence in patients monitored using mHealth [ Time Frame: 0-12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516474


Contacts
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Contact: Karen Cross, MD, PhD 416-864-6060 ext 77393 crosska@smh.ca
Contact: Julie Perry, MSc, PhD 416-864-6060 ext 77393 perryj@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
South Riverdale Community Health Centre
West Park Healthcare Centre
Women's College Hospital
Publications:
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03516474    
Other Study ID Numbers: 17-365C
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Michael's Hospital, Toronto:
nir
diabetes
diabetic foot ulcer (DFU).
wound
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies