Abnormal Plantar Pressure in Patients With Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Complications

Intervention / Treatment
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* Other: retrospective observational study with no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with diabetes<br>Data from medical records from : non-ulcer patients with DM (diabetes mellitus) from the Diabetic Foot Centre (DFC) in Wroclaw. As it is a retrospective analysis no intervention is planned. | Other: retrospective observational study with no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal Plantar Pressure Distribution | 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) | 1 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Positive Test for Neuropathy | Peripheral neuropathy is assessed with questions and clinical evaluation. A nurse asks the patient about stinging, numbness, tingling, or burning of the foot. Ten-gram monofilament and tuning fork (128 MHz) tests are administered. Monofilament is applied in 10 locations on the sole and one on the dorsal part of the foot for checking the loss of protective sensation. A positive monofilament test is considered to be the lack of sensation of tightness in at least 6 of 11 tested sites. The tuning fork is applied for vibration detection to both ankles, the first metatarsophalangeal joint, and the anterior aspect of the shin bone sites. A positive vibration test is considered to be no detection of vibration in three of four test sites.Two positive test results and typical symptoms of neuropathy are the basis for confirmation of peripheral symmetric sensory neuropathy (PSSN). The condition required for the occurrence of these disorders was symmetry. | 1 visit | 
| BMI | kg/m2 | 1 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot, pedobarography, diabetic neuropathy, plantar pressure