CClinicalTrials.gg
CompletedNCT03088566Updated May 5, 2022

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

An interventional study of The D-Foot method and Conventional foot screening in Diabetic Foot, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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?"

02

Conditions studied

  • Diabetic Foot

Browse trials for

03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 111 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

*being unable to read and understand the Swedish language

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
111 participants (actual)

Study arms

  • 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

  • Active comparator
    Conventional foot screening

    The patients are being foot screened according to conventional methods.

    Procedure: Conventional foot screening

Interventions

  • ProcedureThe 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.

  • ProcedureConventional foot screening

    The foot screening is performed with clinical conventional methods.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: one month

  2. 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

    Time frame: one month

Secondary outcomes

  1. PREM

    The system usability scale will be used to calculate the level of usability among the patients that were randomized to the D-Foot group

    Time frame: one month

  2. Patients reported outcome measure (PROM)

    The answers from the EQ-5D will be used to describe the health related quality of life of the study participants

    Time frame: one month

07

Study locations

1 site
  • Department of Prostetics & Orthotics
    Gothenburg, Region Västragötaland 41285, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03088566
Lead sponsor
Sahlgrenska University Hospital
Responsible party
Ulla Hellstrand Tang (Certified prosthetist and orthotist, Sahlgrenska University Hospital) — Principal investigator
First posted
Mar 23, 2017
Start date
Aug 15, 2017
Primary completion
Dec 15, 2017
Completion
Dec 31, 2021
Last update
May 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion