Abnormal Plantar Pressure in Patients With Diabetes
- Conditions
- Diabetes Complications
- Interventions
- Other: retrospective observational study with no intervention
- Registration Number
- NCT03426566
- Lead Sponsor
- Wroclaw Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 974
- subjects with diabetes mellitus diagnosis
- citizens
- no previous foot ulceration and/or foot surgery
- previous foot ulceration and/or foot surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with diabetes retrospective observational study with no intervention 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.
- Primary Outcome Measures
Name Time Method Abnormal Plantar Pressure Distribution 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 Outcome Measures
Name Time Method BMI 1 visit kg/m2
Number of Participants With Positive Test for Neuropathy 1 visit 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.
Trial Locations
- Locations (1)
Department and Division of Medical Rehabilitation
🇵🇱Wroclaw, Lower Silesia, Poland