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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088566
• Other study ID #: 224651
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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?"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 31, 2021
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Procedure:
• The 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.
• Conventional foot screening
The foot screening is performed with clinical conventional methods.

Locations

Country	Name	City	State
Sweden	Department of Prostetics & Orthotics	Gothenburg	Region Västragötaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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