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Sound waves and nanoparticles join forces to heal diabetic foot wounds

NCT ID NCT07690566

Disease control Sponsor: Deraya 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests a new way to treat diabetic foot ulcers by using ultrasound to deliver tiny particles containing tadalafil (a drug similar to Viagra) directly to the wound. The goal is to see if this approach can help the ulcer heal faster and reduce pain. The trial involves one adult with a diabetic foot ulcer.

What this could mean

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

Active substance
tadalafil nanoparticles delivered via ultrasound
What this could lead to
If successful, this approach could offer a new way to treat hard-to-heal diabetic foot ulcers, potentially reducing the risk of amputation.
What could go wrong
This is a case study of just one person, so results may not apply to others. The treatment is experimental and its safety and effectiveness are not yet proven.

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

1 person

The number who actually took part.

Started

Sep 2025

Finished

Dec 2025

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

30 to 55 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: * At least 30 years old. * Presence of a DFU, Wagner 1 extending at least through the dermis provided it is below the medial aspect of the malleolus. * The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer. * Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study. * Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1 Exclusion Criteria: * Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes. * Investigators, in the opinion of the investigator, is suspected of cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. * Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

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

Amputation Diabete mellitus Diabetic foot Wound healing delayed

Contacts and locations

Locations

  • Deraya university, physiotherapy clinics

    Minya, 05673, Egypt

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