Abnormal Plantar Pressure in Patients With Diabetes
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|ClinicalTrials.gov Identifier: NCT03426566|
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment|
|Diabetes Complications||Other: retrospective observational study with no intervention|
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 ( DM- diabetes mellitus).
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 Type :||Observational|
|Actual Enrollment :||974 participants|
|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|
|Actual Study Start Date :||September 2012|
|Primary Completion Date :||December 2012|
|Study Completion Date :||January 2014|
patients with diabetes
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
- abnormal plantar pressure distribution [ Time Frame: 15 months ]static pedobarographic test with semi-quantitative assessment
- neuropathy [ Time Frame: 15 months ]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 symmetric, peripheral, sensory polyneuropathy. The condition required for the occurrence of these disorders was symmetry.
- BMI [ Time Frame: 15 months ]kg/m2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426566
|Department and Division of Medical Rehabilitation|
|Wroclaw, Lower Silesia, Poland, 54-438|
|Principal Investigator:||Edyta Sutkowska, PhD||Wroclaw Medical University|