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

Sahlgrenska University Hospital111 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

111

Conditions

Diabetic Foot

Interventions

The D-Foot methodPROCEDURE

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 screeningPROCEDURE

The foot screening is performed with clinical conventional methods.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, Sweden

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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