Diabetic Foot
Conditions
Brief 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. 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 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?
Interventions
PROCEDUREThe D-Foot method
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.
PROCEDUREConventional foot screening
The foot screening is performed with clinical conventional methods.
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
The randomisation will be determined by sequencing patients into on of the two groups following the grouping found in closed envelopes.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients reported experience measure (PREM) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PREM | 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 |
| Patients reported outcome measure (PROM) | one month | The answers from the EQ-5D will be used to describe the health related quality of life of the study participants |
Countries
Sweden
Outcome results
None listed