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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
The D-Foot method
Conventional foot screening
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Prostetics & Orthotics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The D-Foot method

Conventional foot screening

Arm Description

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

The patients are being foot screened according to conventional methods.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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
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

Full Information

First Posted
March 10, 2017
Last Updated
May 4, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03088566
Brief Title
Implementation of the D-Foot at the Department of Prosthetics and Orthotics
Official Title
Implementation of the D-Foot at the Department of Prosthetics and Orthotics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
The randomisation will be determined by sequencing patients into on of the two groups following the grouping found in closed envelopes.
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The D-Foot method
Arm Type
Experimental
Arm Description
The patients are being foot screened following the routine that is programmed in the D-Foot.
Arm Title
Conventional foot screening
Arm Type
Active Comparator
Arm Description
The patients are being foot screened according to conventional methods.
Intervention Type
Procedure
Intervention Name(s)
The D-Foot method
Intervention Description
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
Intervention Name(s)
Conventional foot screening
Intervention Description
The foot screening is performed with clinical conventional methods.
Primary Outcome Measure Information:
Title
Patients reported experience measure (PREM)
Description
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
Title
Patients reported experience measure (PREM)
Description
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 Outcome Measure Information:
Title
PREM
Description
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
Title
Patients reported outcome measure (PROM)
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Prostetics & Orthotics
City
Gothenburg
State/Province
Region Västragötaland
ZIP/Postal Code
41285
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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