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Could soundwaves heal diabetic foot ulcers faster?

NCT ID NCT05380544

Symptom relief Sponsor: Hull University Teaching Hospitals NHS Trust 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether high-power soundwaves (shockwave therapy) can help heal diabetic foot ulcers faster. 77 participants will receive either high-dose, low-dose, or sham (fake) treatment over three sessions in one week. Researchers will track healing and quality of life for six months to see if this approach is worth studying further.

What this could mean

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

Active substance
Extracorporeal shockwave therapy (ESWT) - high-power soundwaves delivered to the ulcer
What this could lead to
If it works, this could point toward a new, non-invasive way to help diabetic foot ulcers heal faster and reduce amputations.
What could go wrong
This is a small pilot study testing feasibility, not effectiveness. The ideal dose is unknown, and results may not confirm benefit.

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

77 people

The number who actually took part.

Started

Apr 2022

Expected to finish

May 2032

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.

Ages

18 to 120 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: * At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks * Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25) * Capacity to consent to participate in the trial and given written informed consent * Willing to be randomised to either sham, low-dose or high-dose ESWT * Willing to consent to photography of the index DFU * Willing to comply with the follow up schedule Exclusion Criteria: * Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits. * Currently on or planned treatment for osteomyelitis. * Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT. * Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT. * All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT. * Active participants in other trials that may conflict with the study outcomes, for example any other wound care trials.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Diabetic foot

Contacts and locations

Locations

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ, United Kingdom

More trials for these conditions

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