Implementation of the D-Foot at the Department of Prosthetics and Orthotics

Study Overview
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Brief Summary
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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
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The primary research questions arehow 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?

Official Title
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Implementation of the D-Foot at the Department of Prosthetics and Orthotics

Conditions
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Diabetic Foot

Intervention / Treatment
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* Procedure: The D-Foot method
* Procedure: Conventional foot screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The D-Foot method<br>The patients are being foot screened following the routine that is programmed in the D-Foot. | Procedure: The D-Foot method<br>* 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.<br>|
| Active Comparator: Conventional foot screening<br>The patients are being foot screened according to conventional methods. | Procedure: Conventional foot screening<br>* The foot screening is performed with clinical conventional methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | one month |