Diabetic FootNCT03088566
Implementation of the D-Foot at the Department of Prosthetics and Orthotics
A study testing The D-Foot method and Conventional foot screening in people with Diabetic Foot, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- The D-Foot method and Conventional foot screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2017to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- diabetes
- patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers
- be able to read and understand the Swedish language
Who cannot join
- being unable to read and understand the Swedish language
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Prostetics & Orthotics
Gothenburg, Region Västragötaland, 41285
About this study
Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.
Read the detailed description
The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"
- Conditions
- Diabetic Foot
- Being tested
- The D-Foot method, Conventional foot screening
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The D-Foot methodProcedure or surgery
The D-Foot method is a standardised routine of foot screening. The D-Foot i web program aimed to be used on a surf plate.
Conventional foot screeningProcedure or surgery
The foot screening is performed with clinical conventional methods.
| Study group | Role | What they receive |
|---|---|---|
| The D-Foot method | Experimental | The patients are being foot screened following the routine that is programmed in the D-Foot. Receives: Procedure: The D-Foot method |
| Conventional foot screening | Active comparator | The patients are being foot screened according to conventional methods. Receives: Procedure: Conventional foot screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients reported experience measure (PREM)
Orthotic and Prosthetic Users survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method. MEASURE is scored to range from 0 (the lowest possible score) to 100 (the highest possible score).
Measured: one month
Patients reported experience measure (PREM)
A selection of questions from the Swedish national patient survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method
Measured: one month
Secondary outcomes (2)
PREM
The system usability scale will be used to calculate the level of usability among the patients that were randomized to the D-Foot group
Measured: one month
Patients reported outcome measure (PROM)
The answers from the EQ-5D will be used to describe the health related quality of life of the study participants
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start15 Aug 2017
- Primary completion15 Dec 2017
- Study completion31 Dec 2021
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.
- More trials run by Sahlgrenska University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled study. One group will be foot screened following the routine described in the web program, the D-Foot. The other group will be foot screened by the use of conventional methods.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 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
- NCT03088566
- Sponsor's protocol ID
- 224651
- Status last verified
- May 2022
- First submitted
- 10 Mar 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hellstrand Tang U, Tranberg R, Sundberg L, Scandurra I. How do patients and healthcare professionals experience foot examinations in diabetes care? - A randomised controlled study of digital foot examinations versus traditional foot examinations. BMC Health Serv Res. 2024 Nov 12;24(1):1387. doi: 10.1186/s12913-024-11674-w.
PubMed 39533310
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the D-Foot at the Department of Prosthetics and Orthotics
- ClinicalTrials.gov ID
- NCT03088566
- Acronym / sponsor ID
- 224651
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Mar 2017 (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.
Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.
Detailed description
The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled study. One group will be foot screened following the routine described in the web program, the D-Foot. The other group will be foot screened by the use of conventional methods.
| Arm | Type | Receives |
|---|---|---|
| The D-Foot method | Experimental | Procedure: The D-Foot methodThe patients are being foot screened following the routine that is programmed in the D-Foot. |
| Conventional foot screening | Active comparator | Procedure: Conventional foot screeningThe patients are being foot screened according to conventional methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetes
- patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers
- be able to read and understand the Swedish language
Key exclusion criteria (1 listed)
- being unable to read and understand the Swedish language
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 |
|---|---|---|
| The D-Foot methodThe D-Foot method is a standardised routine of foot screening. The D-Foot i web program aimed to be used on a surf plate. | Procedure or surgery | The D-Foot method |
| Conventional foot screeningThe foot screening is performed with clinical conventional methods. | Procedure or surgery | Conventional foot screening |
Primary outcome
Patients reported experience measure (PREM)
Time frame: one month
Orthotic and Prosthetic Users survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method. MEASURE is scored to range from 0 (the lowest possible score) to 100 (the highest possible score).
Patients reported experience measure (PREM)
Time frame: one month
A selection of questions from the Swedish national patient survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method
2 secondary outcomes
PREM
Time frame: one month
Patients reported outcome measure (PROM)
Time frame: one month
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 5 May 2022.
- Derived from this study: PubMed 39533310Hellstrand Tang U, Tranberg R, Sundberg L, Scandurra I. How do patients and healthcare professionals experience foot examinations in diabetes care? - A randomised controlled study of digital foot examinations versus traditional foot examinations. BMC Health Serv Res. 2024 Nov 12;24(1):1387. doi: 10.1186/s12913-024-11674-w.
- 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?
A study testing The D-Foot method and Conventional foot screening in people with Diabetic Foot, 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 3 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 5 May 2022. 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?
Patients reported experience measure (PREM) (time frame: one month). 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?
On the ClinicalTrials.gov record for NCT03088566, 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 5 May 2022.