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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04054804
Acronym
D-Foot2019
Enrollment
100
Registered
2019-08-13
Start date
2019-09-16
Completion date
2019-12-31
Last updated
2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic, Foot Callus, Foot Deformities, Neuropathy;Peripheral

Keywords

risk factor, software, orthotics

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.

Interventions

DIAGNOSTIC_TESTD-Foot

A digital foot check i assessed by using the software D-Foot.

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026