- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03088566
Implementation of the D-Foot at the Department of Prosthetics and Orthotics
May 4, 2022 updated by: Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
111
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Region Västragötaland
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Gothenburg, Region Västragötaland, Sweden, 41285
- Department of Prostetics & Orthotics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
*being unable to read and understand the Swedish language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The D-Foot method
The patients are being foot screened following the routine that is programmed in the D-Foot.
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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.
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Active Comparator: Conventional foot screening
The patients are being foot screened according to conventional methods.
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The foot screening is performed with clinical conventional methods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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one month
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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
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PREM
Time Frame: one month
|
The system usability scale will be used to calculate the level of usability among the patients that were randomized to the D-Foot group
|
one month
|
Patients reported outcome measure (PROM)
Time Frame: one month
|
The answers from the EQ-5D will be used to describe the health related quality of life of the study participants
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2017
Primary Completion (Actual)
December 15, 2017
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
March 10, 2017
First Submitted That Met QC Criteria
March 16, 2017
First Posted (Actual)
March 23, 2017
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 224651
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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