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Abnormal Plantar Pressure in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03426566
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Edyta Sutkowska, 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.

Condition or disease Intervention/treatment
Diabetes Complications Other: retrospective observational study with no intervention

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 ( 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
Observational Model: Other
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
no intervention

Primary Outcome Measures :
  1. abnormal plantar pressure distribution [ Time Frame: 15 months ]
    static pedobarographic test with semi-quantitative assessment

Secondary Outcome Measures :
  1. 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.

  2. BMI [ Time Frame: 15 months ]

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03426566

Department and Division of Medical Rehabilitation
Wroclaw, Lower Silesia, Poland, 54-438
Sponsors and Collaborators
Wroclaw Medical University
Principal Investigator: Edyta Sutkowska, PhD Wroclaw Medical University
  Study Documents (Full-Text)

Documents provided by Edyta Sutkowska, Wroclaw Medical University:

Rich J, Veves A. Forefoot and rearfoot plantar pressures in diabetic patients: correlation to foot ulceration. Wounds2000;12:82-87
Inlow S. The 60-second Foot Exam for People with Diabetes. Wound Care Can2004;2:10-11
Tuna H, Birtane M, Güldiken S et al. The effect of disease duration on foot plantar pressure values in patients with type 2 diabetes mellitus. Turk J Phys Med Rehab2014;60:231-235

Responsible Party: Edyta Sutkowska, MD, PhD; Head of the Department and Division of Medical Rehabilitation, Wroclaw Medical University Identifier: NCT03426566     History of Changes
Other Study ID Numbers: ST 690
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected individual participant data but without individual foot-print picture (mostly paper documentation) ; only the example of foot -print with explanation is available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: no limit
Access Criteria: will be included in an article and/or as supplementary materials
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edyta Sutkowska, Wroclaw Medical University:
diabetic foot
diabetic neuropathy
plantar pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases