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

NCT04054804 | Completed

• 1 other identifier: D-Foot 2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

risk factor; software; orthotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Presence of neuropathy (number)

  2019-2020

• Presence of neuropathy (percentage)

  2019-2020

• Presence of peripheral angiopathy (number )

  2019-2020

• Presence of peripheral angiopathy (percentage )

  2019-2020

• Presence of calluses (number)

  2019-2020

Interventions

D-Foot DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• To be diagnosed diabetes
• Age ≥ 18 years
• To understand the Swedish language.
• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

Location

Related Publications (1)

• Zugner R, Jarl G, Sundberg L, Tang UH. Experiences of using a digital tool, the D-foot, in the screening of risk factors for diabetic foot ulcers. J Foot Ankle Res. 2022 Dec 13;15(1):90. doi: 10.1186/s13047-022-00594-9.

  PMID: 36514099 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Neuritis; Foot Deformities

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 13, 2019
• Study Start: September 16, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)