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Clinical Trials/NCT03088566
NCT03088566
Completed
N/A

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

Sahlgrenska University Hospital, Sweden1 site in 1 country111 target enrollmentAugust 15, 2017
ConditionsDiabetic Foot

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
111
Locations
1
Primary Endpoint
Patients reported experience measure (PREM)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

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?"

Registry
clinicaltrials.gov
Start Date
August 15, 2017
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Ulla Hellstrand Tang

Certified prosthetist and orthotist

Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • PREM(one month)
  • Patients reported outcome measure (PROM)(one month)

Study Sites (1)

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