Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care
NCT ID: NCT06288555
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
274 participants
OBSERVATIONAL
2023-12-21
2024-01-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main question it aims to answer is:
How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?
Participants underwent both the Ipswich touch test and the 10-g monofilament test.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
NCT00760955
The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy
NCT00228345
Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
NCT05043636
Thai PainPREDICT Validation Study
NCT07195045
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
NCT01760707
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVES: The aim of this study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.
METHODS: This diagnostic study with a cross-sectional design focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District, Saraburi Province. Participants underwent both the Ipswich touch test and the 10-g monofilament test. Statistical analysis included evaluating sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, positive likelihood ratio, and Cohen's kappa statistic to assess the diagnostic reliability of the Ipswich touch test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetic patient
This study focused on a group of 274 patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital in Phra Phutthabat District, Saraburi Province. Participants underwent both the Ipswich touch test and the 10-g monofilament test.
Ipswich touch test
Ipswich touch test: A simple test to screen for diabetic peripheral neuropathy (DPN) by lightly touching the patient's toes with the index finger and asking them to identify which foot is touched.
10g monofilament test: A more sensitive test to confirm DPN by applying a thin nylon fiber to different sites on the patient's feet and asking them to indicate when they feel the pressure.
Test procedure: The patient closes their eyes and the examiner performs both tests in a specific sequence and records the results. The tests are done on healthy skin and not on wounds or calluses.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ipswich touch test
Ipswich touch test: A simple test to screen for diabetic peripheral neuropathy (DPN) by lightly touching the patient's toes with the index finger and asking them to identify which foot is touched.
10g monofilament test: A more sensitive test to confirm DPN by applying a thin nylon fiber to different sites on the patient's feet and asking them to indicate when they feel the pressure.
Test procedure: The patient closes their eyes and the examiner performs both tests in a specific sequence and records the results. The tests are done on healthy skin and not on wounds or calluses.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* being able to communicate in Thai by speaking and listening.
Exclusion Criteria
* Alcoholism
* Any cancer
* Cerebrovascular disease
* Chronic foot ulcers, or having foot or toe amputation.
* Chronic kidney disease stage 4 and 5
* Cirrhosis
* Malnutrition
* Neurological disease
* Thyroid hormone deficiency
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ponlawat Hanchana, MD
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ponlawat Hanchana, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ponlawat Hanchana, MD.
Role: PRINCIPAL_INVESTIGATOR
PhraPhutthabat Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ponlawat Hanchana, MD
Changwat Sara Buri, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
International Diabetes Federation. Diabetes Facets and Figures [Internet]. Brussels: International Diabetes Federation; c2023 [updated 2023 Oct 20; cited 2023 Oct 22]. Available from: https://idf.org/about-diabetes/diabetes-facts-figures/
Department of Disease Control. World Diabetes Day Campaign 2021: Emphasizing the importance of diabetes care to ensure widespread treatment [Internet]. Ministry of Public Health; c2021 [updated 2023 Jan 21; cited 2023 Oct 22]. Available from: https://ddc.moph.go.th/brc/news.php?news=21692&deptcode=brc
Leelawattana R, Pratipanawatr T, Bunnag P, Kosachunhanun N, Suwanwalaikorn S, Krittiyawong S, Chetthakul T, Plengvidhya N, Benjasuratwong Y, Deerochanawong C, Mongkolsomlit S, Ngarmukos C, Rawdaree P. Thailand diabetes registry project: prevalence of vascular complications in long-standing type 2 diabetes. J Med Assoc Thai. 2006 Aug;89 Suppl 1:S54-9.
Thirapatarapong W., Srisawasdi G. Epidemiology and direct cost of diabetes related lower extremity amputations at Siriraj hospital. Journal Thai Rehabil Med 2008;18(2):65-9.
Rerkasem K, Kosachunhanun N, Tongprasert S, Khwanngern K, Matanasarawoot A, Thongchai C, Chimplee K, Buranapin S, Chaisrisawadisuk S, Manklabruks A. The development and application of diabetic foot protocol in Chiang Mai University Hospital with an aim to reduce lower extremity amputation in Thai population: a preliminary communication. Int J Low Extrem Wounds. 2007 Mar;6(1):18-21. doi: 10.1177/1534734606298285.
Medical Research and Technology Assessment Institute. Department of Medical Services. Ministry of Public Health. Clinical Practice Guideline: Prevention and Management of Diabetic Foot Complications. Bangkok: New Thammada Printing (Thailand) Co., Ltd.; 2014.
Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM, Holt PJ. Lower extremity amputations--a review of global variability in incidence. Diabet Med. 2011 Oct;28(10):1144-53. doi: 10.1111/j.1464-5491.2011.03279.x.
Gibson TB, Driver VR, Wrobel JS, Christina JR, Bagalman E, DeFrancis R, Garoufalis MG, Carls GS, Gatwood J. Podiatrist care and outcomes for patients with diabetes and foot ulcer. Int Wound J. 2014 Dec;11(6):641-8. doi: 10.1111/iwj.12021. Epub 2013 Feb 4.
Thai Diabetes Society. Clinical practice guideline for diabetes 2023. Bangkok: Thai Diabetes Society; 2023. p. 165-178.
Sudjai N. Sample size calculation for diagnostic test studies. J Med Health Sci. 2020 Aug. 31;27(2):167-82.
Sharma S, Kerry C, Atkins H, Rayman G. The Ipswich Touch Test: a simple and novel method to screen patients with diabetes at home for increased risk of foot ulceration. Diabet Med. 2014 Sep;31(9):1100-3. doi: 10.1111/dme.12450. Epub 2014 Apr 11.
Bowling FL, Abbott CA, Harris WE, Atanasov S, Malik RA, Boulton AJ. A pocket-sized disposable device for testing the integrity of sensation in the outpatient setting. Diabet Med. 2012 Dec;29(12):1550-2. doi: 10.1111/j.1464-5491.2012.03730.x.
Dutra LMA, Moura MC, do Prado FA, De Oliveira Lima G, Melo MC, Fernandez RNM, Novaes MRCG. Is it possible to substitute the monofilament test for the Ipswich Touch Test in screening for peripheral diabetic neuropathy? Diabetol Metab Syndr. 2020 Mar 31;12:27. doi: 10.1186/s13098-020-00534-2. eCollection 2020.
Rayman G, Vas PR, Baker N, Taylor CG Jr, Gooday C, Alder AI, Donohoe M. The Ipswich Touch Test: a simple and novel method to identify inpatients with diabetes at risk of foot ulceration. Diabetes Care. 2011 Jul;34(7):1517-8. doi: 10.2337/dc11-0156. Epub 2011 May 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
020/2566
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.