Foot Ulcer, DiabeticNCT04400344
Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
An observational study of Foot Ulcer, Diabetic, run by Podimetrics, Inc. at 1 site in United States.
Trial summary
The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Ulcer, Diabetic
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2020to 13 May 2021
- 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: Respondents are members of the American Association of Diabetes Educators (AADE) recruited via an introductory email sent out by the AADE on behalf of Podimetrics.
Who may be able to join
- American Association of Diabetes Educators (AADE) member with accurate email address on file with the AADE.
Who cannot join
- AADE member with an inability to read English.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Read the detailed description
Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.
Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?
To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- No intervention
- Keywords
- Diabetic Foot, Ulcer, Care recommendation, Foot Diseases, Diabetic Neuropathies, Diabetes Education, Diabetes, Diabetes Educator, Diabetes Mellitus, Diabetes Complication, Care and treatment
- Medical subject headings
- Diabetic Foot, Ulcer, Foot Diseases, Diabetic Neuropathies, Diabetes Mellitus, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Survey Respondents | Respondents are members of the American Association of Diabetes Educators recruited via an introductory email sent out by the AADE on behalf of Podimetrics. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current state of diabetic foot care education and knowledge base among diabetic educators
Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start13 Jun 2020
- Primary completion13 May 2021 (estimated)
- Study completion13 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Podimetrics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Association of Diabetes Educators
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400344
- Sponsor's protocol ID
- A20-018-682
- Status last verified
- Aug 2020
- First submitted
- 18 May 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the respondent's identity, respondent name and email address will not be recorded within the survey results. No demographic data other than relevant profession, work environment, and number of years as a certified educator will be collected. Additionally, the AADE will not share respondent's name or email addresses with Podimetrics, and the AADE will not have access to the individual survey results, effectively detaching individual results from respondents' identities.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
- ClinicalTrials.gov ID
- NCT04400344
- Acronym / sponsor ID
- A20-018-682
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Diabetic Foot, Ulcer, Care recommendation, Foot Diseases, Diabetic Neuropathies, Diabetes Education, Diabetes, Diabetes Educator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Podimetrics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- American Association of Diabetes Educators
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 13 May 2021 (estimated)
- Study completion
- 13 May 2021 (estimated)
- First posted
- 22 May 2020 (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.
The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Detailed description
Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.
Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?
To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey Respondents | – | Other: No interventionRespondents are members of the American Association of Diabetes Educators recruited via an introductory email sent out by the AADE on behalf of Podimetrics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Respondents are members of the American Association of Diabetes Educators (AADE) recruited via an introductory email sent out by the AADE on behalf of Podimetrics.
Key inclusion criteria (1 listed)
- American Association of Diabetes Educators (AADE) member with accurate email address on file with the AADE.
Key exclusion criteria (1 listed)
- AADE member with an inability to read English.
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 |
|---|---|---|
| No interventionNo intervention | Other | Survey Respondents |
Primary outcome
Current state of diabetic foot care education and knowledge base among diabetic educators
Time frame: One year
Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No. To protect the respondent's identity, respondent name and email address will not be recorded within the survey results. No demographic data other than relevant profession, work environment, and number of years as a certified educator will be collected. Additionally, the AADE will not share respondent's name or email addresses with Podimetrics, and the AADE will not have access to the individual survey results, effectively detaching individual results from respondents' identities.
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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 Foot Ulcer, Diabetic, run by Podimetrics, Inc. at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 31 Aug 2020. 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 States. 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?
Results are not available in the source record.
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?
Current state of diabetic foot care education and knowledge base among diabetic educators (time frame: One year). 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 31 Aug 2020.