Diabetic Foot Ulcer Clinical Trial
— D-Foot2019Official title:
Digital Foot Check by Using the D-Foot, a New Software
Verified date | October 2020 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Prostetics & Orthotics | Gothenburg | Region Västragötaland |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
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 |
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