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

Completed

• Conditions: Foot Deformities; Neuropathy;Peripheral; Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic; Foot Callus

• Registration Number: NCT04054804
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-08-10
• Study First Posted: 2019-08-13
• Study Start: 2019-09-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.	2019-2020	Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Presence of peripheral angiopathy (percentage )	2019-2020	From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.
Presence of foot ulcers (percentage)	2019-2020	From the software, D-Foot, the percentage of participants having foot ulcers will be reported.
Presence of previous foot ulcers (percentage)	2019-2020	From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.
Presence of neuropathy (number)	2019-2020	From the software, D-Foot, the number of participants having neuropathy will be reported.
Presence of calluses (percentage)	2019-2020	From the software, D-Foot, the percentage of participants having calluses will be reported,
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.	2019-2020	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?
Presence of peripheral angiopathy (number )	2019-2020	From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.
Presence of foot deformities (percentage)	2019-2020	From the software, D-Foot, the percentage of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Presence of foot ulcers (number)	2019-2020	From the software, D-Foot, the number of participants having foot ulcers will be reported.
Presence of neuropathy (percentage)	2019-2020	From the software, D-Foot, the percentage of participants having neuropathy will be reported
Presence of calluses (number)	2019-2020	From the software, D-Foot, the number of participants having calluses will be reported.
Presence of foot deformities (number)	2019-2020	From the software, D-Foot, the number of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Presence of previous foot ulcers (number)	2019-2020	From the software, D-Foot, the number of participants with previous foot ulcers will be reported.
Presence of previous amputation in the lower extremities (number)	2019-2020	From the software, D-Foot, the number of participants with previous amputation in the lower extremities will be reported.
Presence of previous amputation in the lower extremities (percentage)	2019-2020	From the software, D-Foot, the percentage of participants with previous amputation in the lower extremities will be reported.

Trial Locations

Locations (1)

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