ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000181303

Ethics application status

Approved

Date submitted

27/01/2017

Date registered

2/02/2017

Date last updated

14/01/2021

Date data sharing statement initially provided

26/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Management of Diabetic Foot Ulcer by Electromagnetic Stimulator Therapy at The Townsville Hospital –A Pilot Study

Scientific title

Efficacy of Electromagnetic Stimulator Therapy for Management of Diabetic Foot Ulcer at The Townsville Hospital –A Pilot Study

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 40 minutes of electromagnetic stimulator therapy for a period of 6 weeks. An electromagnetic stimulator probe will be applied gently against the ulcer surface by treating podiatrist to deliver 150 V, 100 micro, 100 Hz during which the participant may feel light vibration and then crossover for another 6 weeks on fortnightly standard 20-minute 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 electromagnetic stimulator therapy.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Other

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 150 V, 100 micro, 100 Hz impulses of electromagnetic stimulator 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]

Complete or partial foot ulcer healing to be assessed fortnightly using specialized 3-D camera. An ulcer is considered completely healed when it is fully covered by epithelial regeneration and remained so until the next visit in the study. Partially healed ulcer is defined as any reduction in ulcer surface area during the period of the study.

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. Subjects with pacemaker or implantable defibrillators
9. 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 + electromagnetic stimulator therapy 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 electromagnetic stimulator 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

All data elements recorded during the study period will be entered and validated in Microsoft Excel. The time to complete ulcer healing will be measured as the number of days from the start of treatment to the date in which each patient achieves complete wound healing. The comparison between the two treatment groups will be made as the proportion of patients (%) who reached target healing of their ulcers at the end of the study. The time to complete healing and the index of re-epithelization of the wound area will be compared between the two groups. The 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. Where appropriate logistic regression will be employed to determine factors contributing to ulcer healing and to validate the effectives of intervention of electromagnetic stimulator therapy. Confounding factors will be taken into consideration for data analysis to avoid misinterpreting the data. A p value <0.05 will be considered significant.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2017

Actual

1/07/2017

Date of last participant enrolment

Anticipated

31/12/2022

Actual

Date of last data collection

Anticipated

31/03/2023

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

Recruitment postcode(s) [2]

4814 - Thuringowa

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Townsville Hospital Study Education and Research Trust Account (SERTA)

Address [1]

100 Angus Smith Drive
Douglas
QLD 4814

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]

The 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]

15/12/2016

Approval date [1]

22/02/2017

Ethics approval number [1]

Summary

Brief summary

Electromagnetic stimulator therapy (EMST) is a new technology in the care of chronic non-healing wounds [1]. The technology delivers high-energy pressure waves into the wound by enriching the ulcer with adequate blood through formation of new blood vessels. It also stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound [2].  Recently, EMST was reported to be effective in the initiation and acceleration of wound healing in various non-diabetic clinical settings most part involves small case series of bed sores and venous ulcers with scanty reports on diabetic wounds [1-2]. Thus, there is very little information on effect of electromagnetic stimulation in healing ulcers of diabetic foot.  With our earlier report of high rate of diabetic limb amputations in our local population [3-4] we believe EMST technology may have a role to play in the care of our patients.  This technology is simple and can be administered fortnightly as against daily administration in other form of therapies. The treatment with EMST is a non-invasive method and easily tolerated by patients. It is applied through an unfocused applicator which assures an almost painless treatment and no anaesthesia required. Each therapy session only takes about 15 to 60 minutes. As EMST being a viable option of diabetic foot ulcer (DFU) care in our high risk diabetic population yet there is no study to show EMST usefulness in treatment of non-healing DFU in Australia. It would be interesting to find out if this technology would change our current daily diabetic foot ulcer care practice for the betterment of the most costly diabetic complications -DFU. 
The main objective of the study was to evaluate the healing rates of chronic diabetic foot ulcers during a 12-week period in patients treated with EMST and usual care compared to usual care alone.

Reference
1.	Gaurav Thakral et al. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013; 4: 10.3402/dfa.v4i0.22081. 
2.	Jhamb S, Vangaveti VN, Malabu UH. Genetic and molecular basis of diabetic foot ulcers: Clinical review. J Tissue Viability. 2016. pii: S0965-206X(16)30041-9.
3.	Rodrigues BT, Vangaveti VN, Malabu UH. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study. J Diabetes Res. 2016;2016:5941957.
4.	Gilhotra RA, Rodrigues BT, Vangaveti VN, Kan G, Porter D, Sangla KS, Malabu UH. Non-traumatic lower limb amputation in patients with end-stage renal failure on dialysis: an Australian perspective. Ren Fail. 2016 Aug;38(7):1036-43.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Usman H. Malabu

Address

The Townsville Hospital/James Cook University
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/James Cook University
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/James Cook University
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)?

No/undecided IPD sharing reason/comment

Study not yet completed

What supporting documents are/will be available?

Doc. No.	Type	Email
4251	Study protocol	usman.malabu@jcu.edu.au
4252	Statistical analysis plan	usman.malabu@jcu.edu.au
4253	Informed consent form	usman.malabu@jcu.edu.au
4254	Ethical approval	usman.malabu@jcu.edu.au

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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