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

May 4, 2022 updated by: Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

*being unable to read and understand the Swedish language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The D-Foot method
The patients are being foot screened following the routine that is programmed in the D-Foot.
Procedure: The D-Foot method
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.
Active Comparator: Conventional foot screening
The patients are being foot screened according to conventional methods.
Procedure: Conventional foot screening
The foot screening is performed with clinical conventional methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients reported experience measure (PREM)
Time Frame: one month
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)
Time Frame: one month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PREM
Time Frame: one month
The system usability scale will be used to calculate the level of usability among the patients that were randomized to the D-Foot group
one month
Patients reported outcome measure (PROM)
Time Frame: one month
The answers from the EQ-5D will be used to describe the health related quality of life of the study participants
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224651

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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