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Ultrasound-Enhanced gel and nerve stretching may ease diabetic foot pain

NCT ID NCT07683338

Symptom relief Sponsor: Syeda Khatoon e Jannat Welfare Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 23, 2026 · Updated 4 times

Summary

This study tests whether applying pregabalin gel through ultrasound (phonophoresis) combined with nerve flossing exercises can reduce pain and improve sensation in people with diabetic peripheral neuropathy. The trial includes 24 adults aged 40–75 who have chronic nerve pain in their feet. Participants are randomly assigned to receive the combined treatment or a control, and pain levels and sensory function are measured before and after the intervention.

What this could mean

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

Active substance
pregabalin gel
What this could lead to
If effective, this combination approach could offer a non-invasive, drug-sparing way to reduce neuropathic pain and improve sensory function in people with diabetic neuropathy.
What could go wrong
This is a small, early-stage trial with only 24 participants, so results may not apply broadly. The treatment may not outperform standard care, and individual responses can 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

24 people

The number who actually took part.

Started

Feb 2026

Finished

Jul 2026

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

6 to 16 years

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 * Clinically confirmed diagnosis of bilateral spastic cerebral palsy. * Aged 6 to 16 years. * Classified as GMFCS Levels I-III. * Able to stand independently, with or without support. * Presence of clinically significant lower-limb spasticity, defined as Modified Ashworth Scale (MAS) score ≥2. * Demonstrated ambulatory ability with Timed Up and Go (TUG) ≤10 seconds. * Demonstrated walking ability with 6-Minute Walk Test (6MWT) distance of 50-500 meters at baseline. * Able to understand simple verbal commands and participate in structured therapy sessions. * Parent or legal guardian willing to provide written informed consent. * Willing and able to attend the complete 12-week intervention protocol. Exclusion Criteria * Botulinum toxin injection within the previous 6 months. * Recent pharmacological intervention significantly affecting spasticity. * Lower-limb orthopedic surgery within the previous 12 months. * Severe intellectual disability (IQ \<70) or inability to follow simple instructions required for therapy participation. * Uncontrolled seizures, epilepsy, or other neurological conditions that could interfere with participation. * Fixed musculoskeletal contractures limiting standing, stepping, or gait training. * Cardiopulmonary, medical, or orthopedic conditions that contraindicate treadmill-based exercise. * Current participation in another gait-training or rehabilitation research study.

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Conditions

The condition(s) this trial relates to.

cerebral palsy diabetic neuropathy Mobility Limitation neuralgia spastic diplegia

As listed by the trial registrant

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

Bilateral spastic cerebral palsy Cerebral palsy Diabetic neuropathic pain Gait abnormality Mmotor function impairment Painful diabetic peripheral neuropathy Peripheral diabetic neuropathy Spasticity due to cerebral palsy

Contacts and locations

Locations

  • Syeda Khatoon e Jannat Trust Hospital & Special Education Centre

    Faisalabad, Punjab Province, 3800, Pakistan

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