Diabetic FootD-Foot2019NCT04054804
Digital Foot Check by Using the D-Foot, a New Software
An observational study of Diabetic Foot and Diabetic Foot Ulcer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- What is being tested?
- D-Foot
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 16 Sep 2019to 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients being referred to the Department of Prosthetics \& Orthotics at Sahlgrenska Univeristy Hospital with the aim to be provided with insoles, shoes to prevent DFU.
Who may be able to join
- To be diagnosed diabetes
- Age ≥ 18 years
- To understand the Swedish language.
- To work at the department
- To be assigned to work with patients with diabetes at risk of developing foot ulcers.
- Have completed the introduction course D-foot
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Prostetics & Orthotics
Gothenburg, Region Västragötaland, 41285
About this study
Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.
The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.
Read the detailed description
Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. The purpose of the foot examination is to determine whether the patient is at risk of developing diabetic foot ulcers (DFU). Risk factors are: neuropathy, peripheral angiopathy, foot deformities, skin pathologies, earlier history of DFU/amputation. With effective control and examination of the feet, foot complications, such as DFU, can be prevented. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.
The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Neuropathy;Peripheral, Foot Deformities, Foot Callus
- Being tested
- D-Foot
- Keywords
- risk factor, software, orthotics
- Medical subject headings
- Diabetic Foot, Neuritis, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-FootDiagnostic test
A digital foot check i assessed by using the software D-Foot.
What is being measured
The primary outcome is the main question the study is designed to answer.
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.
Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.
Measured: 2019-2020
Secondary outcomes (15)
Presence of neuropathy (number)
From the software, D-Foot, the number of participants having neuropathy will be reported.
Measured: 2019-2020
Presence of neuropathy (percentage)
From the software, D-Foot, the percentage of participants having neuropathy will be reported
Measured: 2019-2020
Presence of peripheral angiopathy (number )
From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.
Measured: 2019-2020
Presence of peripheral angiopathy (percentage )
From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.
Measured: 2019-2020
Presence of calluses (number)
From the software, D-Foot, the number of participants having calluses will be reported.
Measured: 2019-2020
Presence of calluses (percentage)
From the software, D-Foot, the percentage of participants having calluses will be reported,
Measured: 2019-2020
Presence of foot deformities (number)
From the software, D-Foot, the number of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Measured: 2019-2020
Presence of foot deformities (percentage)
From the software, D-Foot, the percentage of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Measured: 2019-2020
Presence of foot ulcers (number)
From the software, D-Foot, the number of participants having foot ulcers will be reported.
Measured: 2019-2020
Presence of foot ulcers (percentage)
From the software, D-Foot, the percentage of participants having foot ulcers will be reported.
Measured: 2019-2020
Presence of previous foot ulcers (number)
From the software, D-Foot, the number of participants with previous foot ulcers will be reported.
Measured: 2019-2020
Presence of previous foot ulcers (percentage)
From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.
Measured: 2019-2020
Presence of previous amputation in the lower extremities (number)
From the software, D-Foot, the number of participants with previous amputation in the lower extremities will be reported.
Measured: 2019-2020
Presence of previous amputation in the lower extremities (percentage)
From the software, D-Foot, the percentage of participants with previous amputation in the lower extremities will be reported.
Measured: 2019-2020
System Usability Scale (SUS). The score range from 0-100 and a SUS score above a 68 would be considered above average and anything below 68 is below average.
The SUS provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. SUS allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. In this setting the aim is to evaluate how certified prosthetists \& orthotists experience the use the web program D-Foot when they examine the patients feet?
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start16 Sep 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Hellstrand Tang, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054804
- Sponsor's protocol ID
- D-Foot 2019
- Acronym
- D-Foot2019
- Status last verified
- Oct 2020
- First submitted
- 25 Jul 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zugner R, Jarl G, Sundberg L, Tang UH. Experiences of using a digital tool, the D-foot, in the screening of risk factors for diabetic foot ulcers. J Foot Ankle Res. 2022 Dec 13;15(1):90. doi: 10.1186/s13047-022-00594-9.
PubMed 36514099
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Foot Check by Using the D-Foot, a New Software
- ClinicalTrials.gov ID
- NCT04054804
- Acronym / sponsor ID
- D-Foot2019 / D-Foot 2019
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Neuropathy;Peripheral, Foot Deformities, Foot Callus
- Keywords
- risk factor, software, orthotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Aug 2019 (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.
Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.
The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.
Detailed description
Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. The purpose of the foot examination is to determine whether the patient is at risk of developing diabetic foot ulcers (DFU). Risk factors are: neuropathy, peripheral angiopathy, foot deformities, skin pathologies, earlier history of DFU/amputation. With effective control and examination of the feet, foot complications, such as DFU, can be prevented. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys.
The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics \& Orthotics based on the digital foot check.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being referred to the Department of Prosthetics \& Orthotics at Sahlgrenska Univeristy Hospital with the aim to be provided with insoles, shoes to prevent DFU.
Key inclusion criteria (6 listed)
- To be diagnosed diabetes
- Age ≥ 18 years
- To understand the Swedish language.
- To work at the department
- To be assigned to work with patients with diabetes at risk of developing foot ulcers.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| D-FootA digital foot check i assessed by using the software D-Foot. | Diagnostic test | – |
Primary outcome
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.
Time frame: 2019-2020
Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.
15 secondary outcomes
Presence of neuropathy (number)
Time frame: 2019-2020
Presence of neuropathy (percentage)
Time frame: 2019-2020
Presence of peripheral angiopathy (number )
Time frame: 2019-2020
Presence of peripheral angiopathy (percentage )
Time frame: 2019-2020
Presence of calluses (number)
Time frame: 2019-2020
Presence of calluses (percentage)
Time frame: 2019-2020
Presence of foot deformities (number)
Time frame: 2019-2020
Presence of foot deformities (percentage)
Time frame: 2019-2020
Presence of foot ulcers (number)
Time frame: 2019-2020
Presence of foot ulcers (percentage)
Time frame: 2019-2020
Presence of previous foot ulcers (number)
Time frame: 2019-2020
Presence of previous foot ulcers (percentage)
Time frame: 2019-2020
Presence of previous amputation in the lower extremities (number)
Time frame: 2019-2020
Presence of previous amputation in the lower extremities (percentage)
Time frame: 2019-2020
System Usability Scale (SUS). The score range from 0-100 and a SUS score above a 68 would be considered above average and anything below 68 is below average.
Time frame: 2019-2020
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 28 Oct 2020.
- Derived from this study: PubMed 36514099Zugner R, Jarl G, Sundberg L, Tang UH. Experiences of using a digital tool, the D-foot, in the screening of risk factors for diabetic foot ulcers. J Foot Ankle Res. 2022 Dec 13;15(1):90. doi: 10.1186/s13047-022-00594-9.
- Individual participant dataSharing planned: No
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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 and Diabetic Foot Ulcer, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 6 inclusion and 0 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 28 Oct 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 Sweden. 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?
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used. (time frame: 2019-2020). 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 NCT04054804, which also lists 1 linked publication.
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 28 Oct 2020.