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Diabetic FootNCT06288555

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

An observational study of Diabetic Foot, run by Ponlawat Hanchana, MD at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Foot
What is being tested?
Ipswich touch test
How many people
274 participants
Where
1 siteThailand
Study dates
21 Dec 2023to 23 Jan 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • AIDS
  • Alcoholism
  • Any cancer
  • Cerebrovascular disease
  • Chronic foot ulcers, or having foot or toe amputation.
  • Chronic kidney disease stage 4 and 5
Show all 10Show fewer
  • Cirrhosis
  • Malnutrition
  • Neurological disease
  • Thyroid hormone deficiency

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ponlawat Hanchana, MD

    Changwat Sara Buri, 18120

Other trials in Thailand

About this study

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.

Read the detailed 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.

Conditions
Diabetic Foot
Being tested
Ipswich touch test
Keywords
Diabetes mellitus, Ipswich touch test, Accuracy, Sensitivity
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipswich touch testDiagnostic test

    Also called 10-g monofilament 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.

Study groups in NCT06288555
Study groupRoleWhat they receive
Diabetic patientThis 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.
Receives: Diagnostic Test: Ipswich touch test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The accuracy of the Ipswich touch test

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start21 Dec 2023
  3. Primary completion23 Jan 2024
  4. Study completion23 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
274 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288555
Sponsor's protocol ID
020/2566
Status last verified
Mar 2024
First submitted
18 Feb 2024
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data was save inform of Microsoft excel spreadsheet and Stata file.

Publications

  • 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.

    PubMed 17717878

  • 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.

    PubMed 17344197

  • 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.

    PubMed 21388445

  • 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.

    PubMed 23374540

  • 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.

    PubMed 24673517

  • 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.

    PubMed 22672290

  • 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.

    PubMed 32266011

  • 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.

    PubMed 21593300

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot, run by Ponlawat Hanchana, MD at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The accuracy of the Ipswich touch test (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06288555, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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