Diabetic Foot UlcerNCT06000722
SGLT-i Use in Diabetic Foot Ulcer Disease
An observational study of Diabetic Foot Ulcer, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. 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 Ulcer
- What is being tested?
- eDelphi method
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2023to 30 Apr 2024
- 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: Participants in the Delphi study will consist of n=20 healthcare practitioners and will be recruited from a convenience sample, and representing a range of specialties and clinical backgrounds.
Who may be able to join
- Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease
Who cannot join
- Potential participants who do not give informed consent. Potential participants who will not be able to participate in both rounds of the Delphi process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Generation of Expert Consensus-based Clinical Guidelines for the Use of Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors in Patients With Diabetic Foot Ulcer Disease: a Delphi Study
Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. However, one recent study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this finding has not been replicated in other similar studies. However, as a result, there has been limited further investigation into this issue and as such the use of SGLT2i's in those with DFUD remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population.
In the absence of further randomised controlled trials investigating the use of SGLT2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. The Delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios.
Read more
Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD.
Methods: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.
The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. Two rounds of the Delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. This process is expected to take 4-6 months. The analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the Delphi process.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- eDelphi method
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDelphi methodOther
This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare practitioners | Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease Receives: Other: eDelphi method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delphi Round 1
Each participant will provided with the clinical statements regarding the use of SGLT2i's in patients with diabetic foot ulcer disease, and sent the link to an online questionnaire. Within the first questionnaire round the participants will be asked to rate these statements i.e. strongly agree, agree, uncertain (probably agree), uncertain (probably disagree), disagree, strongly disagree. Participants will be given three weeks to complete this questionnaire, and will be sent reminder emails during this time. This will establish priorities amongst the statements listed. As a result of completing round one, areas of disagreement and agreement will be identified and a level of consensus will begin to form.
Measured: 3 weeks
Delphi Round 2
The second round of the questionnaire will consist of a summary of the items and ratings from the previous round. Participants will be asked to revise his/her judgments or to specify why they wish to remain outside of the consensus. This round gives the Delphi participants an opportunity to make further clarifications of both the information \& their judgment of the relative importance of the items. Round 2 will be initiated 1 month after the completion of round 1. If consensus is not reached on the majority of statements following round 2, and third and final round may be added in order to reach consensus.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Dec 2023
- Primary completion28 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000722
- Sponsor's protocol ID
- 40318
- Status last verified
- May 2024
- First submitted
- 14 Aug 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Generation of Expert Consensus-based Clinical Guidelines for the Use of Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors in Patients With Diabetic Foot Ulcer Disease: a Delphi Study
- ClinicalTrials.gov ID
- NCT06000722
- Acronym / sponsor ID
- 40318
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Aug 2023 (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.
Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. However, one recent study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this finding has not been replicated in other similar studies. However, as a result, there has been limited further investigation into this issue and as such the use of SGLT2i's in those with DFUD remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population.
In the absence of further randomised controlled trials investigating the use of SGLT2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. The Delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios.
Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD.
Methods: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines.
The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. Two rounds of the Delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. This process is expected to take 4-6 months. The analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the Delphi process.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare practitioners | – | Other: eDelphi methodParticipants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the Delphi study will consist of n=20 healthcare practitioners and will be recruited from a convenience sample, and representing a range of specialties and clinical backgrounds.
Key inclusion criteria (1 listed)
- Participants who are trained healthcare practitioners involved in the care of patients with current or previous diabetic foot ulcer disease
Key exclusion criteria (1 listed)
- Potential participants who do not give informed consent. Potential participants who will not be able to participate in both rounds of the Delphi process.
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 |
|---|---|---|
| eDelphi methodThis is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines. | Other | Healthcare practitioners |
Primary outcome
Delphi Round 1
Time frame: 3 weeks
Each participant will provided with the clinical statements regarding the use of SGLT2i's in patients with diabetic foot ulcer disease, and sent the link to an online questionnaire. Within the first questionnaire round the participants will be asked to rate these statements i.e. strongly agree, agree, uncertain (probably agree), uncertain (probably disagree), disagree, strongly disagree. Participants will be given three weeks to complete this questionnaire, and will be sent reminder emails during this time. This will establish priorities amongst the statements listed. As a result of completing round one, areas of disagreement and agreement will be identified and a level of consensus will begin to form.
Delphi Round 2
Time frame: 3 weeks
The second round of the questionnaire will consist of a summary of the items and ratings from the previous round. Participants will be asked to revise his/her judgments or to specify why they wish to remain outside of the consensus. This round gives the Delphi participants an opportunity to make further clarifications of both the information \& their judgment of the relative importance of the items. Round 2 will be initiated 1 month after the completion of round 1. If consensus is not reached on the majority of statements following round 2, and third and final round may be added in order to reach consensus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by University of Leicester at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delphi Round 1 (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 8 May 2024.