ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001221549

Ethics application status

Approved

Date submitted

5/11/2015

Date registered

9/11/2015

Date last updated

3/09/2019

Date data sharing statement initially provided

3/09/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Management of Chronic Diabetic Foot Ulcer by Extracorporeal Shockwave Therapy at The Townsville Hospital

Scientific title

Efficacy of Extracorporeal Shockwave Therapy for Management of Diabetic Foot Ulcer at The Townsville Hospital

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Diabetic Foot Ulcer

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Skin

Other skin conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Twenty five subjects with diabetic foot ulcer will be treated fortnightly with standard 20-minute wound care (debridement and normal saline dressing) first, to be followed by 10 minutes of shockwave therapy for a period of 6 weeks. A handheld shockwave device will be applied gently against the ulcer surface by treating podiatrist to deliver 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density during which the participant may feel light vibration and then crossover for another 6 weeks on fortnightly standard wound care alone with total duration of the study period of 12 weeks. Log of device use time will be utilized to monitor adherence of the shockwave therapy.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Twenty five subjects with diabetic foot ulcer will be treated with 20-minute standard wound care (debridement and normal saline dressing) fortnightly for a period of 6 weeks and then crossover for another 6 weeks on fortnightly 300 + 100/cm2 impulses of shockwave at 0.11 mJ/cm2 energy flux density to be applied evenly to the ulcer surface in addition to standard wound care alone giving a total duration of the study period of 12 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Partial or complete foot ulcer healing to be assessed fortnightly using specialized 3-D camera

Timepoint [1]

Fortnightly assessment at the time of treatment for the 12-week study period

Secondary outcome [1]

Proportion of participants who achieve a significant (20%) reduction of serum levels if interleukin 6 (IL-6)

Timepoint [1]

Completion of the 12-week study

Eligibility

Key inclusion criteria

1. Diabetes age >18 years
2. Stable documented diabetic foot ulcer of full-thickness skin defect requiring >14 days of healing.
3. Exclusion of other etiologies of foot ulcer.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.).
2. Any major surgery up to 4 weeks prior to the day of enrolment or any planned surgery prior to study completion including any major surgical intervention for the diabetic foot ulcer.
3. Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g. Lupus erythematodes, scleroderma, etc.), chronic inflammatory diseases (e.g. inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma.
4. Treatment with normothermic or hyperbaric oxygen therapy.
5. Skin and dermal substitutes within 30 days prior to study enrolment.
6. Enzymatic debridement treatment.
7. Participation in any other clinical trial.
8. Inability to comply with study protocol.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All subjects who fit the selection criteria will be invited to participate, and if willing will be provided with information on the study and participant consent will be obtained and then randomized. Patients in each stratum will be assigned numbers using a central stratified randomization scheme.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomization list will be prepared by an independent statistician by the method of computer-generated random numbers for each treatment. Patients in each stratum will be assigned numbers using a central stratified randomization scheme designed to provide 1:1 of patients in the 2 groups. Patients will be randomized to initial standard care + shockwave to be followed by standard care alone for another 6 weeks. The other group will have first 6 weeks of standard care alone to be followed by 6 weeks of both shockwave therapy and standard care.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The appropriate sample size was attained by assuming an anticipated difference in wound healing time of 12% (=66 days from an assumed mean of 75 days for diabetic foot ulcer patients at week 12 between the intervention and control group and a within patient variability (standard deviation) of 10days. A power set to 80% yields a calculated sample size of 22 patients per arm. Adding an additional estimated attrition rate of close to 15% = 3 patients per arm leads to an overall planned sample size of 25 patients per arm, and 50 patients in total.

Descriptive statistics including frequency tables 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 22. 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. Chi-squared analysis will be performed for categorical variables and student T test or Mann Whitney U test will be carried out for continuous variables for parametric or non-parametric data respectively. ANOVA will be used for determining differences among multiple groups. A p value <0.05 will be considered significant.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2016

Actual

2/01/2017

Date of last participant enrolment

Anticipated

4/10/2019

Actual

Date of last data collection

Anticipated

10/01/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Government Department of Health

Address [1]

Queensland Policy and Advisory Committee for new Technology
Leve 2, 15 Butterfield St
Herston QLD 4006

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Townsville Hospital

Address

100 Angus Smith Drive
Douglas
QLD 4814

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Townsville Hospital and Health Service Human Resaerch Ethics Committee

Ethics committee address [1]

100 Angus Smith Drive
Douglas
QLD 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2015

Approval date [1]

30/07/2015

Ethics approval number [1]

Summary

Brief summary

Extracorporeal shockwave therapy (ESWT) is a new technology in the care of chronic non-healing wounds. The technology delivers high-energy pressure waves into the wound thereby enriching the ulcer with adequate blood through formation of new blood vessels. It also inhibits infection with its antibacterial property. Furthermore, it stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound.  Recently, ESWT was reported to be effective in the initiation and acceleration of wound healing in various clinical settings including longstanding diabetic foot ulcers. The effectiveness of ESWT in wound healing, especially in treatment of diabetic foot ulcers has been demonstrated in numerous trials (1-2). It has been shown to be more effective value for money compared to hyperbaric oxygen therapy in management of chronic diabetic wounds (3). There are evidences demonstrating reduced length of stay for admitted patients when using this treatment model (3-4). Its safety profile has been proven in various studies (1-4). Numerous scientific investigations have been conducted on biological mechanism of action of ESWT in animals and humans and both proved to be safe and effective (5-6). Furthermore, it has been demonstrated that ESWT therapy achieves long-term healing results in diabetic wound care (7). Thus using this technology at The Townsville Hospital would likely improve the weighted activity unit per bed day figure for medical patients by increasing the total bed days saved, as that capacity will be filled by current access block / unmet demand of the chronic diabetic foot wounds at the hospital.  

In spite of these facts, ESWT technology has not been utilised in the care of diabetic foot ulcer patients in Australia in general and at The Townsville Hospital in particular. This is despite the fact that this technology is non-invasive, simple to use, well tolerated by patients, and only needs to be administered on fortnightly basis whereas even more invasive therapies need more frequent administration. Furthermore, ESWT is applied through an unfocused applicator which assures an almost painless treatment with no anaesthesia required and each therapy session only taking about 10 to 30 minutes. 

The main objective of this study was to evaluate wound healing rate and anti-inflammatory effect of shockwave therapy in subjects with diabetic foot ulcer at the Townsville Hospital, Australia.

References 
1. Wang C, Kuo Y, Wu R et al. J Surg Res. 2009; 152: 96-103.
2. Moretti B, Notarnicola A. et al. BMC Musculoskeletal Disorders 2009, 10:54, 1-8.
3. Wang CJ, Wu RW, Yang YJ. Diabetes Res Clin Pract. 2011 ;92(2):187-93. 
4. Saggini R, Figus A, et al.. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. 
5. Mittermayr R, Antonic V, et al. Wound Repair Regen. 2012;20(4):456-65.
6. Kuo YR, Wang CT, et al. Wound Repair Regen. 2009;17(4):522-30. 
7. Wang CJ et al. J Surg Res. 2014;189(2):366-72.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

Contact person for public queries

Name

Usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814.

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

Contact person for scientific queries

Name

Usman H. Malabu

Address

The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814.

Country

Australia

Phone

+61-7-4433 1111

Fax

+61-7-4433 2239

usman.malabu@jcu.edu.au

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, individual participant data underlying published results only

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication

Available to whom?

researchers who provide a methodologically sound proposal

Available for what types of analyses?

for IPD meta-analyses, etc.

How or where can data be obtained?

usman.malabu@jcu.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email
4315	Study protocol	usman.malabu@jcu.edu.au
4316	Statistical analysis plan	usman.malabu@jcu.edu.au
4317	Ethical approval	usman.malabu@jcu.edu.au
4318	Informed consent form	usman.malabu@jcu.edu.au

Results publications and other study-related documents

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No additional documents have been identified.

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