Peripheral NeuropathyACTNCT07163000
Earlier Diagnosis of Peripheral Neuropathy Using A Simple sCreening Tool (ACT)
An observational study of Peripheral Neuropathy and Painful Neuropathy, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Painful Neuropathy, Diabetes (DM)
- How many people
- 150 participants
- Where
- 1 siteQatar
- Study dates
- 11 May 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants attending the outpatients clinic at the diabetes center
Who may be able to join
- Patients with diabetes (T1DM and T2DM)
- Age ≥18
- Able to provide consent.
- Able to sit still for corneal confocal microscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This a cross-sectional cohort study in patients with diabetes with the aim of assessing the validity and diagnostic accuracy of the ACT questionnaire in identifying peripheral neuropathy (PN) in patients with diabetes and explore underlying mechanisms for nerve damage. The primary endpoint is to validate the ACT tool in identifying diabetic painful neuropathy against the DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI) and in relation to underlying small nerve fibre damage (CCM). And the secondary endpoints include the investigation of the association between glycemic indices using continuous glucose monitoring (CGM- Freestyle Libre 3 and iCan) with neuropathic pain (ACT/DN4/MNSI) and small nerve fibre damage (CCM).
Participants will attend 3 visits and the following will be assessed:
- Visit 1(baseline): Consent, screening, CCM, ACT, MNSI, DN4, CGM (Freestyle Libre 3).
- Visit 2 (14-days follow-up): CGM (freestyle Libre 3), ACT, MNSI, DN4
- Visit 3 (between 1-6 months): CGM (iCan)
- Conditions
- Peripheral Neuropathy, Painful Neuropathy, Diabetes (DM)
- Keywords
- Diabetes, Peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Neuropathy, Painful, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the ACT tool
Identification of number of participants with diabetic peripheral neuropathy as assessed by the ACT tool.
Measured: Baseline (Day 1) and then 14 days after visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start11 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Cornell Medical College in Qatar
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble, Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Professor Rayaz A. Malik, PhD, Principal investigator, Weill Cornell Medicine - Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163000
- Sponsor's protocol ID
- 24-00029
- Acronym
- ACT
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The findings of this study will be disseminated both locally, within Qatar, and internationally through presentations at scientific conferences and publications in peer-reviewed journals. De-identified study data may be made available to qualified researchers and clinicians with a legitimate academic interest in peripheral neuropathy. Any data shared externally will be fully coded to exclude protected health information and will be subject to appropriate data-sharing agreements, such as a data use agreement, in accordance with applicable regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earlier Diagnosis of Peripheral Neuropathy Using A Simple sCreening Tool (ACT)
- ClinicalTrials.gov ID
- NCT07163000
- Acronym / sponsor ID
- ACT / 24-00029
- Conditions
- Peripheral Neuropathy, Painful Neuropathy, Diabetes (DM)
- Keywords
- Diabetes, Peripheral neuropathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Weill Cornell Medical College in QatarUniversity, hospital or other
- Collaborators
- Procter and Gamble, Hamad Medical Corporation
- Study start
- 11 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This a cross-sectional cohort study in patients with diabetes with the aim of assessing the validity and diagnostic accuracy of the ACT questionnaire in identifying peripheral neuropathy (PN) in patients with diabetes and explore underlying mechanisms for nerve damage. The primary endpoint is to validate the ACT tool in identifying diabetic painful neuropathy against the DN4 questionnaire, Michigan Neuropathy Screening Instrument (MNSI) and in relation to underlying small nerve fibre damage (CCM). And the secondary endpoints include the investigation of the association between glycemic indices using continuous glucose monitoring (CGM- Freestyle Libre 3 and iCan) with neuropathic pain (ACT/DN4/MNSI) and small nerve fibre damage (CCM).
Participants will attend 3 visits and the following will be assessed:
- Visit 1(baseline): Consent, screening, CCM, ACT, MNSI, DN4, CGM (Freestyle Libre 3).
- Visit 2 (14-days follow-up): CGM (freestyle Libre 3), ACT, MNSI, DN4
- Visit 3 (between 1-6 months): CGM (iCan)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants attending the outpatients clinic at the diabetes center
Key inclusion criteria (4 listed)
- Patients with diabetes (T1DM and T2DM)
- Age ≥18
- Able to provide consent.
- Able to sit still for corneal confocal microscopy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the ACT tool
Time frame: Baseline (Day 1) and then 14 days after visit 1
Identification of number of participants with diabetic peripheral neuropathy as assessed by the ACT tool.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. The findings of this study will be disseminated both locally, within Qatar, and internationally through presentations at scientific conferences and publications in peer-reviewed journals. De-identified study data may be made available to qualified researchers and clinicians with a legitimate academic interest in peripheral neuropathy. Any data shared externally will be fully coded to exclude protected health information and will be subject to appropriate data-sharing agreements, such as a data use agreement, in accordance with applicable regulations and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Rayaz A. Malik, PhD principal investigator
Weill Cornell Medicine - Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy and Painful Neuropathy, run by Weill Cornell Medical College in Qatar at 1 site in Qatar.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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 Qatar. 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?
This study is still under way. Results are not available in the source record yet.
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?
Validation of the ACT tool (time frame: Baseline (Day 1) and then 14 days after visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.