Clinical trial NCT03426566: Abnormal Plantar Pressure in Patients With Diabetes
Official title: Prevention of Foot Injuries - Abnormal Distribution Patterns of Plantar Pressure in Patients With Diabetes and Its Connection to Peripheral Neuropathy, Gender, Age and BMI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Complications
Keywords: diabetic foot
pedobarography
diabetic neuropathy
plantar pressure
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be examined despite the absence of diabetic foot signs or symptoms

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous foot ulceration and/or foot surgery

Primary outcomes:
measure: Abnormal Plantar Pressure Distribution
timeFrame: 1 visit
Secondary outcomes:
measure: Number of Participants With Positive Test for Neuropathy
timeFrame: 1 visit
measure: BMI
timeFrame: 1 visit
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department and Division of Medical Rehabilitation
state: Lower Silesia
Study officials:
affiliation: Wroclaw Medical University
name: Edyta Sutkowska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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