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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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?"

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

The randomisation will be determined by sequencing patients into on of the two groups following the grouping found in closed envelopes.

Study Groups

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The D-Foot method

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

Group Type EXPERIMENTAL

The D-Foot method

Intervention Type 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.

Conventional foot screening

The patients are being foot screened according to conventional methods.

Group Type ACTIVE_COMPARATOR

Conventional foot screening

Intervention Type PROCEDURE

The foot screening is performed with clinical conventional methods.

Interventions

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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.

Intervention Type PROCEDURE

Conventional foot screening

The foot screening is performed with clinical conventional methods.

Intervention Type PROCEDURE

Eligibility Criteria

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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