Abnormal Plantar Pressure in Patients With Diabetes

NCT03426566 | Completed Results

• 1 other identifier: ST 690
• Study Type: observational
• Target: 974
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications

Keywords

diabetic foot; pedobarography; diabetic neuropathy; plantar pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Positive Test for Neuropathy

  1 visit

• BMI

  1 visit

Study Arms (1)

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

Interventions

retrospective observational study with no intervention OTHER

no intervention

patients with diabetes

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• subjects with diabetes mellitus diagnosis
• citizens
• no previous foot ulceration and/or foot surgery

You may not qualify if:

• previous foot ulceration and/or foot surgery

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department and Division of Medical Rehabilitation

Wroclaw, Lower Silesian Voivodeship, 54-438, Poland

Location

Related Publications (18)

• 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. doi: 10.2337/diacare.6.1.26.

  PMID: 6839919 BACKGROUND

• 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. doi: 10.1111/j.1464-5491.1987.tb00867.x.

  PMID: 2956023 BACKGROUND

• 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. doi: 10.1302/0301-620X.67B1.3968150.

  PMID: 3968150 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.2337/diacare.21.10.1714.

  PMID: 9773736 BACKGROUND

• 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.

  PMID: 22271736 BACKGROUND

• 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.

  PMID: 25437079 BACKGROUND

• 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.

  PMID: 26409930 BACKGROUND

• 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.

  PMID: 26211920 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23308404 BACKGROUND

• 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

  BACKGROUND

• Lazaro-Martinez JL, Aragon-Sanchez FJ, Beneit-Montesinos JV, Gonzalez-Jurado MA, Garcia Morales E, Martinez Hernandez 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. doi: 10.7547/1010208.

  PMID: 21622632 BACKGROUND

• 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. doi: 10.1682/jrrd.2005.10.0157.

  PMID: 17123181 BACKGROUND

• 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.

  PMID: 24012295 BACKGROUND

• 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. doi: 10.1038/sj.ijo.0801785.

  PMID: 11753590 BACKGROUND

• 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.

  PMID: 33248407 BACKGROUND

• 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 9;2019:7395769. doi: 10.1155/2019/7395769. eCollection 2019.

  PMID: 31380446 RESULT

MeSH Terms

Conditions

Diabetes Complications; Diabetic Foot; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

Lack of the influence of a type and duration of diabetes mellitus.The neuropathy evaluation based on local recommendations. The semi-quantitative analysis of the pressure map; the retrospective nature of the study.

Results Point of Contact

• Title: Dr Sutkowska Edyta
• Organization: Wroclaw Medical University

edytasutkowska@yahoo.com

0048503077016

Study Officials

• Edyta Sutkowska, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Head of the Department and Division of Medical Rehabilitation

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 8, 2018
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2014
• Last Updated: May 27, 2022
• Results First Posted: June 17, 2019

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: no limit
• Access Criteria: will be included in an article and/or as supplementary materials

Locations

PL (1)