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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06288555
• Other study ID #: 020/2566
• Status: Completed
• Start date: December 21, 2023
• Est. completion date: January 23, 2024

Study information

• Verified date: March 2024
• Source: PhraPhutthabat Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

BACKGROUND: Diabetic foot, a severe complication of diabetes, significantly impairs the quality of life of affected individuals. However, it can be prevented through screening for loss of protective sensation in the foot. Currently, standard screening methods still require specialized equipment and trained medical professionals. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Peripheral Nervous System Diseases

Intervention

Diagnostic 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.

Locations

Country	Name	City	State
Thailand	Ponlawat Hanchana, MD	Saraburi

Sponsors (1)

Lead Sponsor	Collaborator
Ponlawat Hanchana, MD

Country where clinical trial is conducted

Thailand, 

References & Publications (14)

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. — View Citation

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

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: — View Citation

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. — View Citation

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/

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. — View Citation

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. — View Citation

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 2 — View Citation

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. — View Citation

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. — View Citation

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

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

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.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of the Ipswich touch test	sensitivity, specificity, negative predictive value, positive predictive value, negative likelihood ratio, and positive likelihood ratio	1 year