Earlier Diagnosis of Peripheral Neuropathy Using A Simple sCreening Tool (ACT)

NCT07163000 | Active Not Recruiting

• 1 other identifier: 24-00029
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at people with diabetes (type 1 and type 2 diabetes) to see how well a short questionnaire, called the ACT, can identify nerve damage in the feet and legs (also known as peripheral neuropathy). The investigators will compare the ACT questionnaire to other commonly used tools (the DN4 and Michigan Neuropathy Screening Instrument) and to an eye-test that detects small nerve fibers in the eye (called corneal confocal microscopy, or CCM). The main goal is to find out if the ACT questionnaire is accurate in detecting nerve damage and painful nerve damage caused by diabetes. The investigators will also look at whether changes in blood sugar levels, measured with a continuous glucose monitor (Freestyle Libre 3 and iCan), are linked to nerve pain and small nerve fiber damage.

Conditions

Peripheral Neuropathy; Painful Neuropathy; Diabetes (DM)

Keywords

Diabetes; Peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Validation of the ACT tool

  Identification of number of participants with diabetic peripheral neuropathy as assessed by the ACT tool.

  Baseline (Day 1) and then 14 days after visit 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants attending the outpatients clinic at the diabetes center

You may qualify if:

• Patients with diabetes (T1DM and T2DM)
• Age ≥18
• Able to provide consent.
• Able to sit still for corneal confocal microscopy

You may not qualify if:

• Failure to provide informed consent
• Participants with a history of ocular trauma or previous ocular surgery in the preceding 6 months, are allergic to oxybuprocaine or local anesthetics or unable to cooperate by holding still or placing their chin on an optical device
• Other causes of peripheral neuropathy: vitamin B12 deficiency; hypothyroidism; myeloma.
• Cognitively impaired participants
• Pregnant women
• Nursing women

Sponsors & Collaborators

• Weill Cornell Medical College in Qatar: lead
• Procter and Gamble: collaborator
• Hamad Medical Corporation: collaborator

Study Sites (1)

Weill Cornell Medicine-Qatar

Doha, 24144, Qatar

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuropathy, Painful; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Professor Rayaz A. Malik, PhD

  Weill Cornell Medicine - Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 9, 2025
• Study Start: May 11, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the de-identified data will be accessible for 1 year, with possible extensions considered.
• Access Criteria: Access to the research data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of data sharing agreement.

Locations

QA (1)