Digital Foot Check by Using the D-Foot, a New Software (D-Foot2019)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Foot Ulcer; Foot Deformities; Neuropathy;Peripheral; Diabetic Foot Ulcer Neuropathic; Foot Callus
• Intervention / Treatment: Diagnostic test: D-Foot

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Sweden
  • Region Västragötaland
    • Gothenburg, Region Västragötaland, Sweden, 41285
      • Department of Prostetics & Orthotics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of neuropathy (number)	From the software, D-Foot, the number of participants having neuropathy will be reported.	2019-2020
Presence of neuropathy (percentage)	From the software, D-Foot, the percentage of participants having neuropathy will be reported	2019-2020
Presence of peripheral angiopathy (number )	From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.	2019-2020
Presence of peripheral angiopathy (percentage )	From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.	2019-2020
Presence of calluses (number)	From the software, D-Foot, the number of participants having calluses will be reported.	2019-2020
Presence of calluses (percentage)	From the software, D-Foot, the percentage of participants having calluses will be reported,	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.	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.	2019-2020
Presence of foot ulcers (number)	From the software, D-Foot, the number of participants having foot ulcers will be reported.	2019-2020
Presence of foot ulcers (percentage)	From the software, D-Foot, the percentage of participants having foot ulcers will be reported.	2019-2020
Presence of previous foot ulcers (number)	From the software, D-Foot, the number of participants with previous foot ulcers will be reported.	2019-2020
Presence of previous foot ulcers (percentage)	From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.	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.	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.	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?	2019-2020

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: risk factor; software; orthotics
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Endocrine System Diseases; Congenital Abnormalities; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Diabetic Foot; Foot Ulcer; Ulcer; Peripheral Nervous System Diseases; Foot Deformities; Foot Deformities, Congenital
• Other Study ID Numbers: D-Foot 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No