An observational study in Diabetic Foot, Diabetic Foot Ulcer and Diabetic Foot Ulcer Neuropathic, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Sahlgrenska University Hospital · Observational
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.
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.
Patients being referred to the Department of Prosthetics \& Orthotics at Sahlgrenska Univeristy Hospital with the aim to be provided with insoles, shoes to prevent DFU.
Inclusion Criteria for patients:
Inclusion Criteria for certified prosthetist \& orthotists
A digital foot check i assessed by using the software D-Foot.
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.
Time frame: 2019-2020
Presence of neuropathy (number)
From the software, D-Foot, the number of participants having neuropathy will be reported.
Time frame: 2019-2020
Presence of neuropathy (percentage)
From the software, D-Foot, the percentage of participants having neuropathy will be reported
Time frame: 2019-2020
Presence of peripheral angiopathy (number )
From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.
Time frame: 2019-2020
Presence of peripheral angiopathy (percentage )
From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.
Time frame: 2019-2020
Presence of calluses (number)
From the software, D-Foot, the number of participants having calluses will be reported.
Time frame: 2019-2020
Presence of calluses (percentage)
From the software, D-Foot, the percentage of participants having calluses will be reported,
Time frame: 2019-2020
Presence of foot deformities (number)
From the software, D-Foot, the number of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Time frame: 2019-2020
Presence of foot deformities (percentage)
From the software, D-Foot, the percentage of participants having foot deformities eg. hammertoes, hallux valgus will be reported.
Time frame: 2019-2020
Presence of foot ulcers (number)
From the software, D-Foot, the number of participants having foot ulcers will be reported.
Time frame: 2019-2020
Presence of foot ulcers (percentage)
From the software, D-Foot, the percentage of participants having foot ulcers will be reported.
Time frame: 2019-2020
Presence of previous foot ulcers (number)
From the software, D-Foot, the number of participants with previous foot ulcers will be reported.
Time frame: 2019-2020
Presence of previous foot ulcers (percentage)
From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.
Time frame: 2019-2020
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.
Time frame: 2019-2020
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.
Time frame: 2019-2020
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?
Time frame: 2019-2020
Plan to share: No
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Sahlgrenska University Hospital