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Clinical Trials/NCT04054804
NCT04054804
Completed
Not Applicable

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

Sahlgrenska University Hospital, Sweden1 site in 1 country100 target enrollmentSeptember 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
100
Locations
1
Primary Endpoint
The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2019
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Ulla Hellstrand Tang

Principal Investigator

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The questionnaire Orthotic and Prosthetic Users Survey (OPUS) will be used.

Time Frame: 2019-2020

Participants satisfaction with devices and services at the Department of Prosthetics and Orthotics will be evaluated.

Secondary Outcomes

  • Presence of foot ulcers (number)(2019-2020)
  • Presence of peripheral angiopathy (percentage )(2019-2020)
  • Presence of foot ulcers (percentage)(2019-2020)
  • Presence of previous foot ulcers (percentage)(2019-2020)
  • Presence of neuropathy (number)(2019-2020)
  • Presence of calluses (percentage)(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.(2019-2020)
  • Presence of peripheral angiopathy (number )(2019-2020)
  • Presence of foot deformities (percentage)(2019-2020)
  • Presence of neuropathy (percentage)(2019-2020)
  • Presence of calluses (number)(2019-2020)
  • Presence of foot deformities (number)(2019-2020)
  • Presence of previous foot ulcers (number)(2019-2020)
  • Presence of previous amputation in the lower extremities (number)(2019-2020)
  • Presence of previous amputation in the lower extremities (percentage)(2019-2020)

Study Sites (1)

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