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Completed

NCT Number: NCT04054804

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic Diabetic Neuropathies Endocrine System Diseases Foot Callus Foot Deformities Foot Ulcer Leg Ulcer Musculoskeletal Diseases Nervous System Diseases Neuritis Neuromuscular Diseases Neuropathy;Peripheral Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-Foot

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Presence of neuropathy (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants having neuropathy will be reported.

  2. Presence of neuropathy (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants having neuropathy will be reported

  3. Presence of peripheral angiopathy (number )

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants having peripheral angiopathy will be reported.

  4. Presence of peripheral angiopathy (percentage )

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants having peripheral angiopathy will be reported.

  5. Presence of calluses (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants having calluses will be reported.

  6. Presence of calluses (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants having calluses will be reported,

  7. Presence of foot deformities (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants having foot deformities eg. hammertoes, hallux valgus will be reported.

  8. Presence of foot deformities (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants having foot deformities eg. hammertoes, hallux valgus will be reported.

  9. Presence of foot ulcers (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants having foot ulcers will be reported.

  10. Presence of foot ulcers (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants having foot ulcers will be reported.

  11. Presence of previous foot ulcers (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants with previous foot ulcers will be reported.

  12. Presence of previous foot ulcers (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants with previous foot ulcers will be reported.

  13. Presence of previous amputation in the lower extremities (number)

    Time frame: 2019-2020

    From the software, D-Foot, the number of participants with previous amputation in the lower extremities will be reported.

  14. Presence of previous amputation in the lower extremities (percentage)

    Time frame: 2019-2020

    From the software, D-Foot, the percentage of participants with previous amputation in the lower extremities will be reported.

  15. 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.

    Time frame: 2019-2020

    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?

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: D-Foot2019

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2019
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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