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Clinical Trials/NCT03426566
NCT03426566CompletedNot Applicable

Prevention of Foot Injuries - Abnormal Distribution Patterns of Plantar Pressure in Patients With Diabetes and Its Connection to Peripheral Neuropathy, Gender, Age and BMI

Wroclaw Medical University1 site in 1 country974 target enrollmentStarted: September 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
974
Locations
1
Primary Endpoint
Abnormal Plantar Pressure Distribution

Study Overview

Brief Summary

The prevalence of abnormal plantar pressure distribution (APD) and its connection with various factors among patients with diabetes is not known. The purpose of this study was to evaluate the prevalence of the APD and its connection with selected factors among patients with diabetes.

Detailed Description

The abnormal plantar pressure distribution (APD) plays a key role in the formation of plantar calluses which are responsible for diabetic foot ulcer.

The knowledge of APD is necessary to plan proper prevention in the group of patients with diabetes mellitus (DM).

Medical records from previous patients' visits of non-ulcer patients with diabetes were retrospectively analysed. The relationship between APD, obtained during a pedobarographic test as a semi-quantitative assessment with colourful print analysis, and neuropathy, gender, age and BMI was searched.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • subjects with diabetes mellitus diagnosis
  • no previous foot ulceration and/or foot surgery

Exclusion Criteria

  • previous foot ulceration and/or foot surgery

Outcomes

Primary Outcomes

Abnormal Plantar Pressure Distribution

Time Frame: 1 visit

static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)

Secondary Outcomes

  • BMI(1 visit)
  • Number of Participants With Positive Test for Neuropathy(1 visit)

Investigators

Sponsor
Wroclaw Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edyta Sutkowska

MD, PhD; Head of the Department and Division of Medical Rehabilitation

Wroclaw Medical University

Study Sites (1)

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