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Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

NCT05380544 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-10-02

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Foot

Interventions

DEVICE

Extracorporeal Shockwave Therapy

ESWT will be given at 0.1mJ/mm2, 5 pulses/second and penetration of 5mm. Each intervention will be delivered in 3x30minute sessions over 7 days.

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Louise Hitchman, MBBSMRCSMSc · Hull York Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2023-10-31
Completion
2032-05-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380544 on ClinicalTrials.gov