Diabetes Complications
Conditions
Keywords
diabetic foot, pedobarography, diabetic neuropathy, plantar pressure
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.
Interventions
OTHERretrospective observational study with no intervention
no intervention
Sponsors
Wroclaw Medical University
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| BMI | 1 visit | kg/m2 |
Countries
Poland
Participant flow
Recruitment details
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.
Pre-assignment details
Patients without previous ulcerations or foot surgery were evaluated.
Participants by arm
| Arm | Count |
|---|---|
| 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.
retrospective observational study with no intervention: no intervention | 974 |
| 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.
retrospective observational study with no intervention: no intervention | 1,948 |
| Total | 2,922 |
Baseline characteristics
| Characteristic | Patients With Diabetes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 496 Participants |
| Age, Categorical Between 18 and 65 years | 478 Participants |
| Age, Continuous | 64.6 years STANDARD_DEVIATION 11.15 |
| Region of Enrollment Poland | 974 participants |
| Sex: Female, Male Female | 523 Participants |
| Sex: Female, Male Male | 451 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: Patients with diabetes mellitus but without active or past foot ulcer or surgical procedure within the feet. Abnormal plantar pressure distribution (APD) - means number of participants with symmetrical abnormal pressure distribution; No APD- without such kind a distribution.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Diabetes | Abnormal Plantar Pressure Distribution | patients with APD | 894 Participants |
| Patients With Diabetes | Abnormal Plantar Pressure Distribution | patients without APD | 80 Participants |
Secondary
BMI
kg/m2
Time frame: 1 visit
Population: Patients after BMI were assigned to one of two groups : BMI\<35 kg/m2 or ≥35 kg/m2
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Diabetes | BMI | BMI<35 kg/m2 | 821 Participants |
| Patients With Diabetes | BMI | BMI ≥35 kg/m2 | 153 Participants |
Secondary
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
Population: Patients with DM, without active or past ulcer or surgery within the feet.The data was collected, grouped and analyzed separately for: PSSN, motor neuropathy (MN): MN-Calluses and MN-Feet deformity. One patient can developed PSSN and calluses and feet deformity (and thus his/her result was incorporated into each arm) or one of these variables.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | MN feet deformity | positive | 176 Participants |
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | PSSN | negative | 907 Participants |
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | PSSN | positive | 67 Participants |
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | MN calluses | negative | 645 Participants |
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | MN calluses | positive | 329 Participants |
| Patients With Diabetes | Number of Participants With Positive Test for Neuropathy | MN feet deformity | negative | 798 Participants |