Clinical trial NCT04054804: Digital Foot Check by Using the D-Foot, a New Software
Official title: Digital Foot Check by Using the D-Foot, a New Software
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Diabetic Foot Ulcer Neuropathic
Neuropathy;Peripheral
Foot Deformities
Foot Callus
Keywords: risk factor
software
orthotics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.
timeFrame: 2019-2020
Secondary outcomes:
measure: Presence of neuropathy (number)
timeFrame: 2019-2020
measure: Presence of neuropathy (percentage)
timeFrame: 2019-2020
measure: Presence of peripheral angiopathy (number )
timeFrame: 2019-2020
measure: Presence of peripheral angiopathy (percentage )
timeFrame: 2019-2020
measure: Presence of calluses (number)
timeFrame: 2019-2020
measure: Presence of calluses (percentage)
timeFrame: 2019-2020
measure: Presence of foot deformities (number)
timeFrame: 2019-2020
measure: Presence of foot deformities (percentage)
timeFrame: 2019-2020
measure: Presence of foot ulcers (number)
timeFrame: 2019-2020
measure: Presence of foot ulcers (percentage)
timeFrame: 2019-2020
measure: Presence of previous foot ulcers (number)
timeFrame: 2019-2020
measure: Presence of previous foot ulcers (percentage)
timeFrame: 2019-2020
measure: Presence of previous amputation in the lower extremities (number)
timeFrame: 2019-2020
measure: Presence of previous amputation in the lower extremities (percentage)
timeFrame: 2019-2020
measure: 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.
timeFrame: 2019-2020
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Prostetics & Orthotics
state: Region Västragötaland
Study officials:
References: