Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000165785p
Ethics application status
Submitted, not yet approved
Date submitted
24/11/2021
Date registered
1/02/2022
Date last updated
1/02/2022
Date data sharing statement initially provided
1/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Extracorporeal shock wave therapy (ESWT) compared to electromagnetic stimulator therapy (EMST) for the management of recurrent diabetic foot ulcers
Scientific title
Efficacy of extracoporeal shock wave therapy (ESWT) compared to electromagnetic stimulator therapy (EMST) for the treatment of recurrent diabetic foot ulcers
Secondary ID [1] 305884 0
Nil
Universal Trial Number (UTN)
Trial acronym
PREVENT-DFU = Prevention of Recurrence of Diabetic Foot Ulcer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot ulcers 324434 0
Condition category
Condition code
Metabolic and Endocrine 321927 321927 0 0
Diabetes
Skin 322211 322211 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a 12 Month single-centre, two-campus, randomized, -controlled clinical trial to compare Extracorporeal shock wave therapy (ESWT) + standard of care (SOC) or electromagnetic stimulator therapy (EMST) + SOC as intervention arm.

The ESWT treatment will be delivered at the Townsville university hospital or any approved sites by a by a experienced podiatrist in administering the treatment. The treatment will start with slow delivery of the shockwave impulses into the area of wound site, until the patient is accustomed to the nature of the treatment. Then, the ESWT impulses of 300 + 100/cm2 will be applied at 0.11 mJ/cm2 energy flux density evenly applied to foot/calves bilaterally every month for 12 months. The whole treatment session will take up to 30 minutes/participant.

The EMST will be delivered at the Townsville university hospital or any approved sites by a by a experienced podiatrist in administering the treatment. The treatment will be delivery of electromagnetic stimulation therapy of 150 V, 100 µs, 100 Hz, lasting 45 minutes will be applied to the ulcer surface once every month for a total of twelve treatments.
Intervention code [1] 322279 0
Prevention
Intervention code [2] 322505 0
Treatment: Devices
Intervention code [3] 322506 0
Treatment: Other
Comparator / control treatment
This study is a 12 Month single-centre, two-campus, randomized, -controlled clinical trial with control being the Standard of care (SOC)
The standard of care is; A standard therapy will consist of a monthly podiatrist's foot evaluation for 12 months, along with an education program that focuses on foot complications, self-care practices, and therapeutic insoles and footwear. The treating podiatrist will evaluate the shoes and insoles during regularly scheduled monthly clinic visits and determine whether any components of the shoes or insoles need to be replaced or repaired. The education segment of training will be provided by a podiatrist-orthotist that addresses the etiology of diabetic foot ulcers, risk factors, self-care practices, and early warning signs of diabetic foot disease. Also, all study participants will be advised to record their daily activity in a logbook.
Patients will be advised to inspect their feet daily. If patients identified an area of concern on their foot, they would be instructed to contact the study nurse. The nurse then will schedule an appointment with a study investigator without divulging the treatment group assignment. Likewise, patients will be asked not to discuss their treatment group assignment with the treating physician.
Control group
Active

Outcomes
Primary outcome [1] 329673 0
To assess the number of foot ulcers in the last 3 months assessed as a composite of physical examination and participant self-report.
Timepoint [1] 329673 0
every three months i.e 3, 6, 9 and 12 months post-intervention commencement
Secondary outcome [1] 403400 0
Measurement of serum concentration levels of biological markers (CRP, IL-6, IL-2, IL-10) of inflammation, pro-thrombogenicity, and atherosclerosis from randomization every three months post-intervention commencement.
Timepoint [1] 403400 0
At 3, 6, 9 and 12 Months post intervention commencement
Secondary outcome [2] 403401 0
Measure of peripheral artery disease (PAD) (by determining change in inflammatory markers and local blood circulation) from randomization every three months post-intervention commencement. This will be assessed as a composite outcome. Changes inflammatory markers will be assessed using blood sampling and changes in local blood circulation will be assessed using doppler ultrasound.
Timepoint [2] 403401 0
At 3, 6, 9 and 12 Months post intervention commencement
Secondary outcome [3] 403403 0
To assess diabetic peripheral neuropathy through clinical assessment using monofilament testing
Timepoint [3] 403403 0
At 3, 6, 9 and 12 Months post intervention commencement
Secondary outcome [4] 404530 0
To assess diabetic peripheral neuropathy through nerve conduction studies suing Nerve conduction velocity (NCV) testing
Timepoint [4] 404530 0
At 3, 6, 9 and 12 Months post intervention commencement

Eligibility
Key inclusion criteria
1. Adult subjects greater than or equal to 18 years with a history of diabetic foot ulcers (DFUs) who consented will be included in the study. Both sexes will be enrolled.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with any of the following: coronary bypass, pregnancy, coagulation diseases, or history of neoplasia or other conditions based on the Principal Investigator's clinical judgment
2. Subjects with artificial joints with metallic objects
3. Patient with a pacemaker or implantable defibrillators.
4. Participation in any other clinical trial.
5. Inability to comply with study protocol.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by central randomisation using computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Simple randomisation will be performed to ensure equal numbers of patients in each of three groups i.e. ESWT + standard wound care, EMST + SOC group and the standard wound care groups.
The randomisation sequence will be computer-generated using appropriate online tool. Suitable patients will be enrolled based on the sequence generated with a allocation ratio of 1:1:1 for each of the arms of the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patients with post-randomization data will have their last study assessment carried forward as their final assessment for analyses. Number needed to treat analysis will be undertaken to determine the effectives of treatments.
Descriptive statistics, including frequency tables (including n, mean, median, standard deviation, minimum and maximum for continuous variables and n, frequency and percentage for categorical variables) and graphs will be provided for all variables, as well as for the changes from baseline within each treatment and the differences between the treatment groups at each visit.
All data will be analysed using SPSS Version 25. Tests for normality will be performed, and based on the outcome, parametric or nonparametric tests will be employed to determine the differences between the groups. The results will be given as mean + standard deviation. The chi-squared analysis will be performed for categorical variables, and the Student T-test or Mann Whitney U test will be carried out for continuous variables for parametric or nonparametric data, respectively. ANOVA will be used for determining differences among multiple groups. A p-value <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21197 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 36064 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 310230 0
Hospital
Name [1] 310230 0
Townsville University Hospital
Country [1] 310230 0
Australia
Primary sponsor type
Hospital
Name
Townsville University Hospital
Address
100 Angus Smith Dr, Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 311329 0
None
Name [1] 311329 0
None
Address [1] 311329 0
None
Country [1] 311329 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309914 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309914 0
Ethics committee country [1] 309914 0
Australia
Date submitted for ethics approval [1] 309914 0
30/09/2021
Approval date [1] 309914 0
Ethics approval number [1] 309914 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115814 0
Prof Usman Malabu
Address 115814 0
Department of Endocrinology,
Townsville University Hospital
100 Angus Smith Dr,
Douglas
QLD 4814
Country 115814 0
Australia
Phone 115814 0
+61407586026
Fax 115814 0
Email 115814 0
[email protected]
Contact person for public queries
Name 115815 0
Usman Malabu
Address 115815 0
Department of Endocrinology,
Townsville University Hospital
100 Angus Smith Dr,
Douglas
QLD 4814
Country 115815 0
Australia
Phone 115815 0
+61407586026
Fax 115815 0
Email 115815 0
[email protected]
Contact person for scientific queries
Name 115816 0
Usman Malabu
Address 115816 0
Department of Endocrinology,
Townsville University Hospital
100 Angus Smith Dr,
Douglas
QLD 4814
Country 115816 0
Australia
Phone 115816 0
+61407586026
Fax 115816 0
Email 115816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data of trial participants of individual participant data of published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it, only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Meta analysis
How or where can data be obtained?
email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.