Implementation of the D-Foot at the Department of Prosthetics and Orthotics

NCT03088566 | Completed

• 1 other identifier: 224651
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (2)

• Patients reported experience measure (PREM)

  Orthotic and Prosthetic Users survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method. MEASURE is scored to range from 0 (the lowest possible score) to 100 (the highest possible score).

  one month

• Patients reported experience measure (PREM)

  A selection of questions from the Swedish national patient survey will be used to evaluate if the PREM scores are higher in the group that was foot screened following the D-Foot method

  one month

Secondary Outcomes (2)

• PREM

  one month

• Patients reported outcome measure (PROM)

  one month

Study Arms (2)

The D-Foot method

EXPERIMENTAL

The patients are being foot screened following the routine that is programmed in the D-Foot.

Procedure: The D-Foot method

Conventional foot screening

ACTIVE COMPARATOR

The patients are being foot screened according to conventional methods.

Procedure: Conventional foot screening

Interventions

The D-Foot method PROCEDURE

The D-Foot method is a standardised routine of foot screening. The D-Foot i web program aimed to be used on a surf plate.

The D-Foot method

Conventional foot screening PROCEDURE

The foot screening is performed with clinical conventional methods.

Conventional foot screening

Eligibility Criteria

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

You may qualify if:

• diabetes
• patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers
• be able to read and understand the Swedish language

You may not qualify if:

• \*being unable to read and understand the Swedish language

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

Location

Related Publications (1)

• Hellstrand Tang U, Tranberg R, Sundberg L, Scandurra I. How do patients and healthcare professionals experience foot examinations in diabetes care? - A randomised controlled study of digital foot examinations versus traditional foot examinations. BMC Health Serv Res. 2024 Nov 12;24(1):1387. doi: 10.1186/s12913-024-11674-w.

  PMID: 39533310 DERIVED

MeSH Terms

Conditions

Diabetic Foot

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomisation will be determined by sequencing patients into on of the two groups following the grouping found in closed envelopes.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Certified prosthetist and orthotist

Model Details: Randomised controlled study. One group will be foot screened following the routine described in the web program, the D-Foot. The other group will be foot screened by the use of conventional methods.

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 23, 2017
• Study Start: August 15, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 31, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)