Skip to main content
OpenTrials
Completed

NCT Number: NCT03088566

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

About this study

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?"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Conventional foot screening

Procedure

The foot screening is performed with clinical conventional methods.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2021
First posted
Mar 23, 2017
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.