Digital Foot Check by Using the D-Foot, a New Software

Diabetic Foot Ulcer Clinical Trial

— D-Foot2019  

Official title:

Digital Foot Check by Using the D-Foot, a New Software

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054804
• Other study ID #: D-Foot 2019
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys. The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics & Orthotics based on the digital foot check.

Description:

Patients with diabetes should be thoroughly examined before they are provided with insoles and shoes. The purpose of the foot examination is to determine whether the patient is at risk of developing diabetic foot ulcers (DFU). Risk factors are: neuropathy, peripheral angiopathy, foot deformities, skin pathologies, earlier history of DFU/amputation. With effective control and examination of the feet, foot complications, such as DFU, can be prevented. In the study the feet are examined with the help of a new software, the D-Foot. D-Foot includes questions and surveys. The aim of the of the study is evaluate how the patients experience the visit at the department of Prosthetics & Orthotics based on the digital foot check.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for patients:

• To be diagnosed diabetes
• Age = 18 years
• To understand the Swedish language. Inclusion Criteria for certified prosthetist & orthotists
• To work at the department
• To be assigned to work with patients with diabetes at risk of developing foot ulcers.
• Have completed the introduction course D-foot

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Foot Ulcer Neuropathic
• Foot Callus
• Foot Deformities
• Foot Ulcer
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases
• Ulcer

Intervention

Diagnostic Test:
• D-Foot
A digital foot check i assessed by using the software D-Foot.

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	The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.	Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.	2019-2020
Secondary	Presence of neuropathy (number)	From the software, D-Foot, the number of participants having neuropathy will be reported.	2019-2020
Secondary	Presence of neuropathy (percentage)	From the software, D-Foot, the percentage of participants having neuropathy will be reported	2019-2020
Secondary	Presence of peripheral angiopathy (number )	From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.	2019-2020
Secondary	Presence of peripheral angiopathy (percentage )	From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.	2019-2020
Secondary	Presence of calluses (number)	From the software, D-Foot, the number of participants having calluses will be reported.	2019-2020
Secondary	Presence of calluses (percentage)	From the software, D-Foot, the percentage of participants having calluses will be reported,	2019-2020
Secondary	Presence of foot deformities (number)	From the software, D-Foot, the number of participants having foot deformities eg. hammertoes, hallux valgus will be reported.	2019-2020
Secondary	Presence of foot deformities (percentage)	From the software, D-Foot, the percentage of participants having foot deformities eg. hammertoes, hallux valgus will be reported.	2019-2020
Secondary	Presence of foot ulcers (number)	From the software, D-Foot, the number of participants having foot ulcers will be reported.	2019-2020
Secondary	Presence of foot ulcers (percentage)	From the software, D-Foot, the percentage of participants having foot ulcers will be reported.	2019-2020
Secondary	Presence of previous foot ulcers (number)	From the software, D-Foot, the number of participants with previous foot ulcers will be reported.	2019-2020
Secondary	Presence of previous foot ulcers (percentage)	From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.	2019-2020
Secondary	Presence of previous amputation in the lower extremities (number)	From the software, D-Foot, the number of participants with previous amputation in the lower extremities will be reported.	2019-2020
Secondary	Presence of previous amputation in the lower extremities (percentage)	From the software, D-Foot, the percentage of participants with previous amputation in the lower extremities will be reported.	2019-2020
Secondary	System Usability Scale (SUS). The score range from 0-100 and a SUS score above a 68 would be considered above average and anything below 68 is below average.	The SUS provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. SUS allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. In this setting the aim is to evaluate how certified prosthetists & orthotists experience the use the web program D-Foot when they examine the patients feet?	2019-2020