Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care

NCT06288555 | Completed DMC

• 1 other identifier: 020/2566
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational 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. 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.

Conditions

Diabetic Foot

Keywords

Diabetes mellitus; Ipswich touch test; Accuracy; Sensitivity

Outcome Measures

Primary Outcomes (1)

• The accuracy of the Ipswich touch test

  sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, and positive likelihood ratio

  1 year

Study Arms (1)

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.

Diagnostic Test: Ipswich touch test

Interventions

Ipswich touch test DIAGNOSTIC_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.

Also known as: 10-g monofilament test

Diabetic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes who were receiving services at Nong Khantee Subdistrict Health Promoting Hospital(Primary care) in Phra Phutthabat District, Saraburi Province.

You may qualify if:

• being 18 years old or older, having type 2 diabetes
• being able to communicate in Thai by speaking and listening.

You may not qualify if:

• AIDS
• 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

Sponsors & Collaborators

• Ponlawat Hanchana, MD: lead

Study Sites (1)

Ponlawat Hanchana, MD

Changwat Sara Buri, 18120, Thailand

Location

Related Publications (14)

• 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/

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17717878 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17344197 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21388445 BACKGROUND

• 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.

  PMID: 23374540 BACKGROUND

• Thai Diabetes Society. Clinical practice guideline for diabetes 2023. Bangkok: Thai Diabetes Society; 2023. p. 165-178.

  BACKGROUND

• Sudjai N. Sample size calculation for diagnostic test studies. J Med Health Sci. 2020 Aug. 31;27(2):167-82.

  BACKGROUND

• 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.

  PMID: 24673517 RESULT

• 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.

  PMID: 22672290 RESULT

• 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.

  PMID: 32266011 RESULT

• 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.

  PMID: 21593300 RESULT

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Hypersensitivity

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases

Study Officials

• Ponlawat Hanchana, MD.

  PhraPhutthabat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 1, 2024
• Study Start: December 21, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

TH (1)