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Scientists hunt for blood clues to spot diabetic nerve pain early

NCT ID NCT07518433

Knowledge-focused Sponsor: Zhejiang Chinese Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will analyze blood samples from 90 people — 30 healthy, 30 with diabetes but no nerve issues, and 30 with diabetic peripheral neuropathy (nerve damage causing pain). Researchers will look for unique molecules in the blood that could serve as early warning signs. The goal is to improve diagnosis and understand the disease better, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to detect diabetic nerve damage earlier, and point toward new treatment targets.
What could go wrong
This is an early observational study with only 90 participants, so results may not apply to everyone. It looks for markers, not a treatment, so direct patient benefit is not immediate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll three groups of participants: (1) patients with painful diabetic peripheral neuropathy (P-DPN) meeting defined diagnostic criteria, (2) diabetic patients without peripheral neuropathy, and (3) healthy volunteers without diabetes or neuropathy, matched for sex and age.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with diabetes mellitus (type 1 or type 2) * For the diabetic peripheral neuropathy (DPN) group: meet diagnostic criteria for painful diabetic peripheral neuropathy (P-DPN), defined as persistent pain and/or paresthesia in both lower limbs, with at least one objective sign of neuropathy (reduced ankle reflex, reduced vibration perception, or abnormal nerve conduction velocity when available), and a DN4 score ≥ 4 * For the diabetic control (DC) group: patients with diabetes mellitus but no evidence of peripheral neuropathy * For the healthy control (HC) group: healthy volunteers without diabetes or neuropathy, matched for sex and age * Aged between 18 and 80 years (inclusive) * Able to perform activities of daily living independently and cooperate with study procedures * No severe cardiac, cerebral, hepatic, renal, or other systemic diseases, and no severe mental illness or cognitive impairment * Willing to participate and provide written informed consent Exclusion Criteria: * Peripheral neuropathy caused by factors other than diabetes, including but not limited to hypothyroidism, alcohol abuse, medications, genetic disorders, or other systemic diseases * Presence of limb ulcers, gangrene, or a history of skin ulceration or non-healing wounds * Acute diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, or severe infections within the past 3 months * Severe hepatic or renal impairment, or severe cardiovascular or cerebrovascular diseases (e.g., unstable angina, myocardial infarction, multiple cerebral infarctions, cerebral hemorrhage) * Scars or hyperpigmentation at the testing site that may interfere with accurate measurements * Pregnancy, breastfeeding, or planned pregnancy during the study period * Participation in another interventional clinical trial within 3 months prior to screening * For the diabetic control (DC) group: presence of peripheral neuropathy * For the healthy control (HC) group: history of diabetes mellitus, peripheral neuropathy, or use of medications affecting neurological function

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy diabetic polyneuropathy Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathy (DPN) Pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.