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

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: Procedure: The D-Foot method; Procedure: Conventional foot screening

• Registration Number: NCT03088566
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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 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 Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-23
• Study Start: 2017-08-15
• Primary Completion: 2017-12-15
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The D-Foot method	The D-Foot method	The patients are being foot screened following the routine that is programmed in the D-Foot.
Conventional foot screening	Conventional foot screening	The patients are being foot screened according to conventional methods.

Primary Outcome Measures

Name	Time	Method
Patients reported experience measure (PREM)	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Prostetics & Orthotics; 🇸🇪 Gothenburg, Region Västragötaland, Sweden