An observational study in Diabetes Complications, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Wroclaw Medical University · Observational
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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.
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.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's enrollment of 974 is above the median of 200 across 84 observational studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Wroclaw (where the Diabetic Foot Centre exists) citizens who came spontaneously to be examined despite the absence of diabetic foot signs or symptoms
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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)
Time frame: 1 visit
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.
Time frame: 1 visit
BMI
kg/m2
Time frame: 1 visit
Recruitment period: between October 2009 and December 2010 Medical records were obtained from the Diabetic Foot Centre (DFC) in Wroclaw, Poland and covered a period of fifteen months of work.
| Milestone | Patients With Diabetes |
|---|---|
| Started | 974 |
| Completed | 974 |
| Not completed | 0 |
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)
| Participants | Patients With Diabetes |
|---|---|
| patients without APD | 80 |
| patients with APD | 894 |
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.
| Participants | Patients With Diabetes |
|---|---|
| PSSN — negative | 907 |
| PSSN — positive | 67 |
| MN calluses — negative | 645 |
| MN calluses — positive | 329 |
| MN feet deformity — negative | 798 |
| MN feet deformity — positive | 176 |
kg/m2
| Participants | Patients With Diabetes |
|---|---|
| BMI ≥35 kg/m2 | 153 |
| BMI<35 kg/m2 | 821 |
Collected over Not applicable- observational, retrospective study with medical-records analysis.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Diabetes | — | — | — |
| Age, Categorical(Participants) | Patients With Diabetes |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 478 |
| >=65 years | 496 |
| Age, Continuous(years) | Patients With Diabetes |
|---|---|
| Mean | 64.6 ± 11.15 |
| Sex: Female, Male(Participants) | Patients With Diabetes |
|---|---|
| Female | 523 |
| Male | 451 |
| Region of Enrollment(participants) | Patients With Diabetes |
|---|---|
| Poland | 974 |
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan
Time frame: no limit
Access criteria: will be included in an article and/or as supplementary materials
Ran from Sep 2012 to primary completion in Dec 2012, 3 months.
Results were first posted in Jun 2019, 6 years 6 months after primary completion.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Wroclaw Medical University