Trial Review

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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] 291020 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 301800 0
Diabetic Foot Ulcer 301802 0
Condition category
Condition code
Metabolic and Endocrine 301487 301487 0 0
Diabetes
Skin 301515 301515 0 0
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] 296992 0
Treatment: Devices
Intervention code [2] 296993 0
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] 300882 0
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] 300882 0
Fortnightly assessment at the time of treatment for the 12-week study period
Secondary outcome [1] 331108 0
Proportion of participants who achieve a significant (20%) reduction of serum levels if interleukin 6 (IL-6)
Timepoint [1] 331108 0
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?
No
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
50
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7393 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 15187 0
4814 - Douglas
Recruitment postcode(s) [2] 15188 0
4814 - Thuringowa

Funding & Sponsors
Funding source category [1] 295448 0
Hospital
Name [1] 295448 0
The Townsville Hospital Study Education and Research Trust Account (SERTA)
Country [1] 295448 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive
Douglas
QLD 4814
Country
Australia
Secondary sponsor category [1] 294269 0
None
Name [1] 294269 0
-
Address [1] 294269 0
-
Country [1] 294269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296780 0
The Townsville Hospital and Health Service Human Resaerch Ethics Committee
Ethics committee address [1] 296780 0
Ethics committee country [1] 296780 0
Australia
Date submitted for ethics approval [1] 296780 0
15/12/2016
Approval date [1] 296780 0
22/02/2017
Ethics approval number [1] 296780 0

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

Contacts
Principal investigator
Name 72030 0
Prof Usman H. Malabu
Address 72030 0
The Townsville Hospital/James Cook University
100 Angus Smith Drive
Douglas
QLD 4814
Country 72030 0
Australia
Phone 72030 0
+61-7-4433 1111
Fax 72030 0
+61-7-4433 2239
Email 72030 0
[email protected]
Contact person for public queries
Name 72031 0
Usman H. Malabu
Address 72031 0
The Townsville Hospital/James Cook University
100 Angus Smith Drive
Douglas
QLD 4814
Country 72031 0
Australia
Phone 72031 0
+61-7-4433 1111
Fax 72031 0
+61-7-4433 2239
Email 72031 0
[email protected]
Contact person for scientific queries
Name 72032 0
Usman H. Malabu
Address 72032 0
The Townsville Hospital/James Cook University
100 Angus Smith Drive
Douglas
QLD 4814
Country 72032 0
Australia
Phone 72032 0
+61-7-4433 1111
Fax 72032 0
+61-7-4433 2239
Email 72032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study not yet completed


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4251Study protocol  [email protected]
4252Statistical analysis plan  [email protected]
4253Informed consent form  [email protected]
4254Ethical approval  [email protected]



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.