Diabetic FootNCT05446337
Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
An observational study of Diabetic Foot and Lower Limb Wound, run by University Health Network, Toronto.
Trial summary
University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. 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, Lower Limb Wound, Diabetes
- What is being tested?
- Open-Ended Semi-Structured Interview
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 31 Mar 2025
- 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: Individuals from the Greater Toronto Area (GTA) that are involved with the Diabetes Foot Care and Limb Preservation Pathway through UHN either as patients and their caregivers, healthcare providers, or stakeholders.
Who may be able to join
- Patients and Informal Caregivers:
- Diabetes (Type 1 and Type 2) receiving care within the Diabetes Foot Care and Limb Preservation Pathway
- Outpatient or inpatient care setting
- Non-Patient Participants:
- Healthcare providers providing care
- Stakeholders supporting the clinical pathway development through University Health Network.
- In the early phases of the project a broader audience who may not be involved in the explicit design, outside of those that are designing the program, and may include external and internal stakeholders involved in clinical care, continuity of care, policy decision-making, patients, and caregivers.
Who cannot join
- Not able to provide consent
Trial locations and contacts
No sites are listed yet.
About this study
University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. This study is using a method called developmental evaluation to help map out the system and to provide information in real-time so that the pathway can be adapted and respond to what is learned. The investigators are going to explore different factors (facilitators and barriers) and processes, which help or hinder the development, implementation, and adoption of the pathway. The investigators are also going to find out about the patient and provider's experiences with diabetic foot care, wound care, limb preservation, and amputation. Finally, the study team is going to look at value-based health care for the diabetic foot care pathways and document healthcare resource utilization, costs, and outcomes. The study team will conduct interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the pathway, identifying barriers and facilitators of the process. Once the pathway has started, the study team will look at the way the care is delivered and satisfaction through surveys to patients and practitioners. The study team will also ask about patients' quality of life and their ability to manage diabetes. The study will aim to answer three key questions: What is happening? Why is it happening? and, What are reasonable prospects, and tools for change? The entire study is anticipated to take 3 years to complete.
Read the detailed description
This study is a mixed-methods developmental evaluation study whose objectives are to:
- Explore different factors (facilitators and barriers) and processes, which facilitate or impede the development, implementation, and adoption of Diabetes Foot Care and Limb Preservation Pathways using a multi-level framework.
- Examine the patient and provider experiences with diabetic foot care, wound care, limb preservation, and amputation at UHN and the primary care settings and patient-level outcomes.
The developmental evaluation will consist of an initial component. Further quantitative and qualitative measures will be incorporated into the developmental evaluation as the Diabetic Foot Care and Limb Preservation Pathway develops.
- Pathway Design \& Implementation Case Study This qualitative research component will be completed through ethnographic fieldwork and the conduct of semi-structured interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation, identifying barriers and facilitators of the process. The study team will interview and observe three types of participants: patients and informal caregivers; healthcare providers including program service providers; stakeholders including hospital leadership and policy decision-makers. The research team will also attend meetings and collect and review documents and materials circulated as a part of the pathway development. In addition, social network analysis (SNA) may also be conducted as a part of this component to examine the interaction between stakeholders as well as the organizational dynamics and the fidelity of the intervention.
This study will be conducted in both the community and hospital settings at the University Health Network at Toronto General Hospital, Toronto Western Hospital, The Michener Institute of Education, Toronto Western Hospital Family Health Team (FHT) South Riverdale Community Health Centre, Primary Care Practices participating in the Seamless Care for Optimizing Patient Experience (SCOPE) and will be supported Nurse Navigators and by an Integrated Comprehensive Care (ICC) and associated homecare services.
- Conditions
- Diabetic Foot, Lower Limb Wound, Diabetes, Amputation
- Being tested
- Open-Ended Semi-Structured Interview
- Keywords
- Developmental Evaluation, Care Pathway, Mixed-Methods Study
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-Ended Semi-Structured InterviewOther
Examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation; identifying barriers and facilitators of the process
| Study group | Role | What they receive |
|---|---|---|
| Patients and Informal Care Givers | Individuals living with diabetes who are receiving or have received care through the Diabetes Foot Care and Limb Preservation Pathway at various stages of the care pathway including screening \& prevention, wound care treatment, surgery and monitoring. Receives: Other: Open-Ended Semi-Structured Interview | |
| Healthcare Providers | Medical, Nursing, and other allied healthcare providers including chiropodists, physiotherapists, occupational therapists, social workers, and nutritionists. Receives: Other: Open-Ended Semi-Structured Interview | |
| Stakeholders | Individuals external and internal involved in clinical care, continuity of care, and policy-making including but not limited to senior hospital leadership, decision support, and researchers and policy decision-makers. Receives: Other: Open-Ended Semi-Structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitators and Barriers
Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway
Measured: 9 months
Secondary outcomes (2)
Experience with Care
Experiences with diabetic foot care, wound care, limb preservation and amputation at UHN and the primary care settings and patient-level outcomes
Measured: Duration of evaluation
Value-Based Healthcare
Potential of implementing value-based health care diabetic foot care pathways and document healthcare resource utilization, costs and outcomes.
Measured: Duration of evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University Health Network, 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
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valeria E. Rac, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446337
- Sponsor's protocol ID
- 21-6156
- Other IDs
- PHSTE202201
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Care and Limb Preservation Pathway: Developmental Evaluation Study
- ClinicalTrials.gov ID
- NCT05446337
- Acronym / sponsor ID
- 21-6156
- Conditions
- Diabetic Foot, Lower Limb Wound, Diabetes, Amputation
- Keywords
- Developmental Evaluation, Care Pathway, Mixed-Methods Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Jul 2022 (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.
University Health Network (UHN), working together with local primary care practitioners, patients, and community healthcare services is developing a Diabetic Foot Care and Limb Preservation Care pathway. Our goal is to improve foot care for individuals living with diabetes. This study is using a method called developmental evaluation to help map out the system and to provide information in real-time so that the pathway can be adapted and respond to what is learned. The investigators are going to explore different factors (facilitators and barriers) and processes, which help or hinder the development, implementation, and adoption of the pathway. The investigators are also going to find out about the patient and provider's experiences with diabetic foot care, wound care, limb preservation, and amputation. Finally, the study team is going to look at value-based health care for the diabetic foot care pathways and document healthcare resource utilization, costs, and outcomes. The study team will conduct interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the pathway, identifying barriers and facilitators of the process. Once the pathway has started, the study team will look at the way the care is delivered and satisfaction through surveys to patients and practitioners. The study team will also ask about patients' quality of life and their ability to manage diabetes. The study will aim to answer three key questions: What is happening? Why is it happening? and, What are reasonable prospects, and tools for change? The entire study is anticipated to take 3 years to complete.
Detailed description
This study is a mixed-methods developmental evaluation study whose objectives are to:
- Explore different factors (facilitators and barriers) and processes, which facilitate or impede the development, implementation, and adoption of Diabetes Foot Care and Limb Preservation Pathways using a multi-level framework.
- Examine the patient and provider experiences with diabetic foot care, wound care, limb preservation, and amputation at UHN and the primary care settings and patient-level outcomes.
The developmental evaluation will consist of an initial component. Further quantitative and qualitative measures will be incorporated into the developmental evaluation as the Diabetic Foot Care and Limb Preservation Pathway develops.
- Pathway Design \& Implementation Case Study This qualitative research component will be completed through ethnographic fieldwork and the conduct of semi-structured interviews of stakeholders, including patient representatives, and will examine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation, identifying barriers and facilitators of the process. The study team will interview and observe three types of participants: patients and informal caregivers; healthcare providers including program service providers; stakeholders including hospital leadership and policy decision-makers. The research team will also attend meetings and collect and review documents and materials circulated as a part of the pathway development. In addition, social network analysis (SNA) may also be conducted as a part of this component to examine the interaction between stakeholders as well as the organizational dynamics and the fidelity of the intervention.
This study will be conducted in both the community and hospital settings at the University Health Network at Toronto General Hospital, Toronto Western Hospital, The Michener Institute of Education, Toronto Western Hospital Family Health Team (FHT) South Riverdale Community Health Centre, Primary Care Practices participating in the Seamless Care for Optimizing Patient Experience (SCOPE) and will be supported Nurse Navigators and by an Integrated Comprehensive Care (ICC) and associated homecare services.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients and Informal Care Givers | – | Other: Open-Ended Semi-Structured InterviewIndividuals living with diabetes who are receiving or have received care through the Diabetes Foot Care and Limb Preservation Pathway at various stages of the care pathway including screening \& prevention, wound care treatment, surgery and monitoring. |
| Healthcare Providers | – | Other: Open-Ended Semi-Structured InterviewMedical, Nursing, and other allied healthcare providers including chiropodists, physiotherapists, occupational therapists, social workers, and nutritionists. |
| Stakeholders | – | Other: Open-Ended Semi-Structured InterviewIndividuals external and internal involved in clinical care, continuity of care, and policy-making including but not limited to senior hospital leadership, decision support, and researchers and policy decision-makers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from the Greater Toronto Area (GTA) that are involved with the Diabetes Foot Care and Limb Preservation Pathway through UHN either as patients and their caregivers, healthcare providers, or stakeholders.
Key inclusion criteria (7 listed)
- Diabetes (Type 1 and Type 2) receiving care within the Diabetes Foot Care and Limb Preservation Pathway
- Outpatient or inpatient care setting
- Healthcare providers providing care
- Stakeholders supporting the clinical pathway development through University Health Network.
- In the early phases of the project a broader audience who may not be involved in the explicit design, outside of those that are designing the program, and may include external and internal stakeholders involved in clinical care, continuity of care, policy decision-making, patients, and caregivers.
Key exclusion criteria (1 listed)
- Not able to provide consent
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 |
|---|---|---|
| Open-Ended Semi-Structured InterviewExamine the participation and engagement in the Diabetic Foot Care and Limb Preservation Pathway design and implementation; identifying barriers and facilitators of the process | Other | Healthcare Providers, Patients and Informal Care Givers, Stakeholders |
Primary outcome
Facilitators and Barriers
Time frame: 9 months
Key factors related to system readiness and implementation of the Diabetes Foot Care and Limb Preservation pathway
2 secondary outcomes
Experience with Care
Time frame: Duration of evaluation
Value-Based Healthcare
Time frame: Duration of evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
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.
Valeria E. Rac, MD, PhD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Lower Limb Wound, run by University Health Network, 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 7 inclusion and 1 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 18 Jul 2022. 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 James M. Bowen, BScPhm, MSc (416-634-8799, jim.bowen@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facilitators and Barriers (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2022.