NCT05380544: SOLEFUL1

Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

Active, enrolled NA Last updated 2 October 2024

What this trial tests

NA trial testing Extracorporeal Shockwave Therapy in Diabetic Foot in 77 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 April 2022

Primary endpoint
31 October 2023

1 May 2032

Quick facts

Lead sponsor	Hull University Teaching Hospitals NHS Trust
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	77
Start date	13 April 2022
Primary completion	31 October 2023
Estimated completion	1 May 2032
Sites	1 location across United Kingdom

Drugs / interventions tested

• Extracorporeal Shockwave Therapy

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

Hull University Teaching Hospitals NHS Trust

Who can join

Adults 18 to 120, any sex, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Summary of the problem:

Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life.

Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown.

The aim of the study:

1. To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing
2. To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
3. To investigate the cost effectiveness (value for money) of shockwave therapy

Methods

1\. Pilot Trial: Ninety patients with DFU will be randomly assigned to one of three treatment groups:

1. High dose shockwave treatment
2. Low dose shockwave treatment
3. "Sham" shockwave treatment

Each treatment will be delivered in 3x30minute sessions in a 7-day period. Face-to-face follow up appointments will take place 1, 2, 3 and 6 months after treatment to measure ulcer healing and changes in quality-of-life.

Interviews Interviews to explore patient opinion of shockwave therapy, experience in taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (SOLEFUL): A Study Protocol.
   Hitchman L, Iglesias C, Russell D, Smith G, et al · · 2025 · PMID 40159429 · DOI 10.1111/iwj.70176