Diabetic FootMDMNCT03516474
Using mHealth to Modernize Diabetes Care
An observational study of Diabetic Foot, run by Unity Health Toronto.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- MIMOSA Diagnostics
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Diabetes: Type I or Type II.
- Outpatient or inpatient
- Diabetic Foot Ulcer
- Adhere to monitoring schedule
Who cannot join
- Presence of invasive infection requiring intravenous antibiotics
- Cognitively able to give consent \& participate in study
- Active malignancy
- End stage renal disease
- Patients who are participating in another clinical study for ulcer management
- Patients with a known history of poor compliance with medical treatment
- Patients who are unable to understand the aims of the study and not give informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- MIMOSA Diagnostics
- Keywords
- nir, diabetes, diabetic foot ulcer (DFU)., wound
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIMOSA DiagnosticsDevice
Also called MIMOSA
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.
| Study group | Role | What they receive |
|---|---|---|
| St. Michael's Hospital | St. Michael's Hospital is an Acute care centre for the diabetic lower extremity.
n=100 Receives: Device: MIMOSA Diagnostics | |
| South Riverdale Community Health Centre | South Riverdale is a Community Health Centre focused on prevention. n=100 Receives: Device: MIMOSA Diagnostics | |
| Westpark | Westpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100 Receives: Device: MIMOSA Diagnostics | |
| Women's College Hospital | Women's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100 Receives: Device: MIMOSA Diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start15 May 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- South Riverdale Community Health Centre, West Park Healthcare Centre, Women's College Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516474
- Sponsor's protocol ID
- 17-365C
- Acronym
- MDM
- Status last verified
- Apr 2018
- First submitted
- 8 Mar 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23294922Skrepnek 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.
PubMed 26248037Serrano 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.
PubMed 28942581Cross 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.
PubMed 17537120Vashist 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.
PubMed 26852680
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Disruptive Medicine: Reducing Treatment Burden and Improving Access for All Patients With Diabetes Using an mHealth Strategy
- ClinicalTrials.gov ID
- NCT03516474
- Acronym / sponsor ID
- MDM / 17-365C
- Conditions
- Diabetic Foot
- Keywords
- nir, diabetes, diabetic foot ulcer (DFU)., wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- South Riverdale Community Health Centre, West Park Healthcare Centre, Women's College Hospital
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| St. Michael's Hospital | – | Device: MIMOSA DiagnosticsSt. Michael's Hospital is an Acute care centre for the diabetic lower extremity. n=100 |
| South Riverdale Community Health Centre | – | Device: MIMOSA DiagnosticsSouth Riverdale is a Community Health Centre focused on prevention. n=100 |
| Westpark | – | Device: MIMOSA DiagnosticsWestpark is a rehabilitation site focused on post-operative/amputation care and preservation of the opposite limb. n=100 |
| Women's College Hospital | – | Device: MIMOSA DiagnosticsWomen's College Hospital is an outpatient wound clinic focused on the management of DFUs. n=100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Diabetes: Type I or Type II.
- Outpatient or inpatient
- Diabetic Foot Ulcer
- Adhere to monitoring schedule
Key exclusion criteria (7 listed)
- Presence of invasive infection requiring intravenous antibiotics
- Cognitively able to give consent \& participate in study
- Active malignancy
- End stage renal disease
- Patients who are participating in another clinical study for ulcer management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIMOSA DiagnosticsAlso: MIMOSAThe 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. | Device | South Riverdale Community Health Centre, St. Michael's Hospital, Westpark, Women's College Hospital |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 23294922Pelletier 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: PubMed 26248037Skrepnek 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.
- Background: PubMed 28942581Serrano 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.
- Background: PubMed 17537120Cross 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.
- Background: PubMed 26852680Vashist 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.
- Patient smartphone useLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Cross, MD, PhD (416-864-6060 ext. 77393, crosska@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower rates of DFU recurrence in patients monitored using mHealth (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03516474, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.