Abnormal Plantar Pressure in Patients With Diabetes

Diabetes Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426566
• Other study ID #: ST 690
• Status: Completed
• Start date: September 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2022
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: January 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus

Intervention

Other:
• retrospective observational study with no intervention
no intervention

Locations

Country	Name	City	State
Poland	Department and Division of Medical Rehabilitation	Wroclaw	Lower Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & Publications (18)

Bakker K, Apelqvist J, Lipsky BA, Van Netten JJ; International Working Group on the Diabetic Foot. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:2-6. doi: 10.1002/dmrr.2694. — View Citation

Bakker K, Schaper NC; International Working Group on Diabetic Foot Editorial Board. The development of global consensus guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:116-8. doi: 10.1002/dmrr.2254. Review. — View Citation

Boulton AJ, Betts RP, Franks CI, Newrick PG, Ward JD, Duckworth T. Abnormalities of foot pressure in early diabetic neuropathy. Diabet Med. 1987 May-Jun;4(3):225-8. — View Citation

Boulton AJ, Hardisty CA, Betts RP, Franks CI, Worth RC, Ward JD, Duckworth T. Dynamic foot pressure and other studies as diagnostic and management aids in diabetic neuropathy. Diabetes Care. 1983 Jan-Feb;6(1):26-33. — View Citation

Carreau L, Niezgoda H, LeBlond S, Trainor A, Orsted H, Woodbury MG. A prospective, descriptive study to assess the reliability and usability of a rapid foot screen for patients with diabetes mellitus in a complex continuing care setting. Ostomy Wound Manage. 2013 Jan;59(1):28-34. — View Citation

Choi YR, Lee HS, Kim DE, Lee DH, Kim JM, Ahn JY. The diagnostic value of pedobarography. Orthopedics. 2014 Dec;37(12):e1063-7. doi: 10.3928/01477447-20141124-52. — View Citation

Crawford F, Cezard G, Chappell FM, Murray GD, Price JF, Sheikh A, Simpson CR, Stansby GP, Young MJ. A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS). Health Technol Assess. 2015 Jul;19(57):1-210. doi: 10.3310/hta19570. Review. — View Citation

Duckworth T, Boulton AJ, Betts RP, Franks CI, Ward JD. Plantar pressure measurements and the prevention of ulceration in the diabetic foot. J Bone Joint Surg Br. 1985 Jan;67(1):79-85. — View Citation

Frykberg RG, Lavery LA, Pham H, Harvey C, Harkless L, Veves A. Role of neuropathy and high foot pressures in diabetic foot ulceration. Diabetes Care. 1998 Oct;21(10):1714-9. — View Citation

Hills AP, Hennig EM, McDonald M, Bar-Or O. Plantar pressure differences between obese and non-obese adults: a biomechanical analysis. Int J Obes Relat Metab Disord. 2001 Nov;25(11):1674-9. — View Citation

Inlow S. The 60-second Foot Exam for People with Diabetes. Wound Care Can2004;2:10-11

Lázaro-Martínez JL, Aragón-Sánchez FJ, Beneit-Montesinos JV, González-Jurado MA, García Morales E, Martínez Hernández D. Foot biomechanics in patients with diabetes mellitus: doubts regarding the relationship between neuropathy, foot motion, and deformities. J Am Podiatr Med Assoc. 2011 May-Jun;101(3):208-14. — View Citation

Ledoux WR, Shofer JB, Cowley MS, Ahroni JH, Cohen V, Boyko EJ. Diabetic foot ulcer incidence in relation to plantar pressure magnitude and measurement location. J Diabetes Complications. 2013 Nov-Dec;27(6):621-6. doi: 10.1016/j.jdiacomp.2013.07.004. Epub 2013 Sep 4. — View Citation

Perell KL, Merrill V, Nouvong A. Location of plantar ulcerations in diabetic patients referred to a Department of Veterans Affairs podiatry clinic. J Rehabil Res Dev. 2006 Jul-Aug;43(4):421-6. — View Citation

Rich J, Veves A. Forefoot and rearfoot plantar pressures in diabetic patients: correlation to foot ulceration. Wounds2000;12:82-87

Sutkowska E, Fortuna P, Kaluza B, Sutkowska K, Hodurek P, Fleszar MG. The impact of Sample Handling Time on metformin serum concentration. Biomed Pharmacother. 2021 Jan;133:110971. doi: 10.1016/j.biopha.2020.110971. Epub 2020 Nov 25. — View Citation

Sutkowska E, Sutkowski K, Sokolowski M, Franek E, Dragan S Sr. Distribution of the Highest Plantar Pressure Regions in Patients with Diabetes and Its Association with Peripheral Neuropathy, Gender, Age, and BMI: One Centre Study. J Diabetes Res. 2019 Jul — View Citation

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

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	1 visit
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.	1 visit
Secondary	BMI	kg/m2	1 visit