D-Foot2019: Digital Foot Check by Using the D-Foot, a New Software

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT04054804

Collaborator

(none)

100

Enrollment

Location

3.5

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic Neuropathy;Peripheral Foot Deformities Foot Callus	Diagnostic Test: D-Foot

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 Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 16, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Outcome Measures

Primary Outcome Measures

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

Presence of neuropathy (number) [2019-2020]
From the software, D-Foot, the number of participants having neuropathy 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 peripheral angiopathy (number ) [2019-2020]
From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.
Presence of peripheral angiopathy (percentage ) [2019-2020]
From the software, D-Foot, the percentage of participants having peripheral angiopathy 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 calluses (percentage) [2019-2020]
From the software, D-Foot, the percentage 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 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 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 (number) [2019-2020]
From the software, D-Foot, the number of participants with previous 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 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.
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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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