Trial Outcomes & Findings for Abnormal Plantar Pressure in Patients With Diabetes (NCT NCT03426566)
NCT ID: NCT03426566
Last Updated: 2022-05-27
Results Overview
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)
COMPLETED
974 participants
1 visit
2022-05-27
Participant Flow
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.
Patients without previous ulcerations or foot surgery were evaluated.
Unit of analysis: feet
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
974 1948
|
|
Overall Study
COMPLETED
|
974 1948
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abnormal Plantar Pressure in Patients With Diabetes
Baseline characteristics by cohort
| Measure |
Patients With Diabetes
n=1948 feet
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
478 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
496 Participants
n=5 Participants
|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
523 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
451 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
974 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 visitPopulation: 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.
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)
Outcome measures
| Measure |
Patients With Diabetes
n=974 Participants
Patients with diabetes from Diabetic Foot Centre
|
|---|---|
|
Abnormal Plantar Pressure Distribution
patients without APD
|
80 Participants
|
|
Abnormal Plantar Pressure Distribution
patients with APD
|
894 Participants
|
SECONDARY outcome
Timeframe: 1 visitPopulation: 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.
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.
Outcome measures
| Measure |
Patients With Diabetes
n=974 Participants
Patients with diabetes from Diabetic Foot Centre
|
|---|---|
|
Number of Participants With Positive Test for Neuropathy
PSSN · negative
|
907 Participants
|
|
Number of Participants With Positive Test for Neuropathy
PSSN · positive
|
67 Participants
|
|
Number of Participants With Positive Test for Neuropathy
MN calluses · negative
|
645 Participants
|
|
Number of Participants With Positive Test for Neuropathy
MN calluses · positive
|
329 Participants
|
|
Number of Participants With Positive Test for Neuropathy
MN feet deformity · negative
|
798 Participants
|
|
Number of Participants With Positive Test for Neuropathy
MN feet deformity · positive
|
176 Participants
|
SECONDARY outcome
Timeframe: 1 visitPopulation: Patients after BMI were assigned to one of two groups : BMI\<35 kg/m2 or ≥35 kg/m2
kg/m2
Outcome measures
| Measure |
Patients With Diabetes
n=974 Participants
Patients with diabetes from Diabetic Foot Centre
|
|---|---|
|
BMI
BMI ≥35 kg/m2
|
153 Participants
|
|
BMI
BMI<35 kg/m2
|
821 Participants
|
Adverse Events
Patients With Diabetes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place