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Electric pulses may bring back lost foot sensation in diabetes

NCT ID NCT07807748

Symptom relief Sponsor: Burdur Mehmet Akif Ersoy University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Diabetic polyneuropathy damages nerves in the feet, dulling the sense of touch and raising the risk of unnoticed injuries. This trial tests whether transcutaneous electrical nerve stimulation (TENS) can restore that sensation. Researchers compare high-frequency TENS, low-frequency TENS, and a sham treatment in 30 people with long-standing diabetic neuropathy. Over eight weeks, participants receive sessions five days a week, with electrodes on the calf and sole. The main outcome is the lightest touch felt on the big toe, measured before and after treatment.

What this could mean

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

Active substance
Transcutaneous electrical nerve stimulation (TENS), a device that delivers mild electrical currents through skin electrodes
What this could lead to
If effective, TENS could become a simple, drug-free way to restore protective foot sensation and reduce ulcer risk in diabetic neuropathy.
What could go wrong
The trial is small (30 participants) and early, so results may not apply broadly. TENS may not improve sensation, and individual responses vary.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Type 1 or type 2 diabetes mellitus * Clinically confirmed diabetic peripheral polyneuropathy of at least five years' duration, diagnosed by an endocrinologist during routine outpatient follow-up on the basis of distal symmetric sensory symptoms together with abnormal bedside sensory testing * Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score of 9 or above * Standardized Mini-Mental State Examination score above 24 * Glycated haemoglobin (HbA1c) below 8.5% * Wagner grade 0 feet (intact plantar skin without ulceration) * Willing to continue prescribed diet and hypoglycaemic treatment unchanged throughout the study Exclusion Criteria: * Use of a cardiac pacemaker * Alcohol dependence * Peripheral arterial disease * Renal failure * Hepatic failure * Hypothyroidism * Vitamin B12 deficiency * Folate deficiency * Sarcoidosis * Active infection * Malignancy * Coagulopathy * Skin lesion, discolouration, or allergic reaction at the electrode sites

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy diabetic polyneuropathy peripheral nervous system disorder

As listed by the trial registrant

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

Diabetic neuropathies Diabetic neuropathy, painful Peripheral nervous system diseases

Contacts and locations

Locations

  • Akdeniz University City:

    Antalya, Turkey (Türkiye)

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