Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000277347
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
23/02/2017
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-inferiority randomised controlled trial comparing wound healing with compression therapy to electric stimulation therapy (Wound ELECT Trial)
Scientific title
Multi site randomised controlled trial comparing clinical effectiveness of electric stimulation therapy compared to or in combination with compression therapy in wound healing of chronic lower leg ulcers (Wound ELECT Trial)
Secondary ID [1] 291053 0
none
Universal Trial Number (UTN)
Trial acronym
Wound ELECT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic venous, lymphoedema and mixed venous/lymphoedema ulcers 301846 0
Lower leg oedema 301847 0
Condition category
Condition code
Cardiovascular 301524 301524 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 301525 301525 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An electric stimulation therapy—Bodyflow (Trademark) Therapy—involves the application of electrodes to the limb which delivers a mild transdermal electrical stimulus targeting stimulation of smooth muscle (Tunica media) to promote the stimulation of arterial, venous and lymphatic systems.
Participants will be randomly allocated to one of three treatment groups in total n = 208 participants will be required.
1 Compression therapy (control) n=69
2 Electric Stimulation Therapy (with no compression therapy) n=69
3 Electric Stimulation Therapy and compression therapy n=69
The Bodyflow (Trademark) Electric Stimulation Device is a small portable device suitable for self-administration in the home setting. Recruits to the Bodyflow group will be given a demonstration on the use of Bodyflow by the clinician on recruitment including the placement of the electrodes, management of the battery powered unit. Written instruction are also given to the recruits to reinforce the instructions on the operation of the device. For recruits in the compression and electrical stimulation group, compression is not removed during treatment.
Guidelines for utilising the Bodyflow (Trademark) Therapy is four times daily for 20 minute sessions over 14 weeks, implemented by the participant or an informal carer in the home environment. Electrodes are attached to the lower limb around the wound (not directly over it) or above or below compression therapy if institu. The device is pre-set to a single, non-adjustable specific low frequency found between one and two Hertz, a current that specifically targets smooth muscle. Use of the device can create a pulsing or tingling sensation. There are no reported serious adverse events anticipated from the use of the Bodyflow (Trademark) Therapy.
Adherence to treatment in the Bodyflow group will be automatically logged by the machine. Continuing and ongoing data collection tools will be completed on each assessment visit and subsequent 2 week visit, 6 week visit, 10 week visit and 14 week visit.
Intervention code [1] 297041 0
Treatment: Devices
Comparator / control treatment
Standard care of compression therapy will be provided to study participants as per sections 1 and 2 of the Flow Chart for the Management of Venous Leg Ulcers (Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcer) or as outlined by the Best Practice for the Management of Lymphoedema: International Consensus. All care will be provided by registered healthcare professionals with specialist skills in wound care. Participants randomised to the compression therapy group will be encouraged to use the highest compression possible. Participants will be encouraged to use their compression therapy either 24/7 or from waking in the morning to going to bed at night. Financial support to encourage participants to purchase new compression stockings or to increase their level of compression bandaging will be provided. The study will require n=208 in total (69 per study group). To accommodate a 10% attrition of study participants the study will recruit a sample of n=76 per study group: N=228 overall.
Control group
Active

Outcomes
Primary outcome [1] 300933 0
Healed Study wound defined as 100% epithelization/wound closure .
Wound will be traced and measured using ImageJ is a public domain electronic Java image processing and analysis program.
Timepoint [1] 300933 0
From screening and recruitment recruits will be monitored at 2 weeks, 6 weeks, 10 weeks and 14 weeks.
Secondary outcome [1] 331231 0
Secondary outcome 1
Wound healing algorithms to assess- Percentage of area change (PAC) for the ‘study wound. (determined from wound planimetry methods and corroborated by digital image planimetry.
Timepoint [1] 331231 0
From screening and recruitment recruits will be monitored at 2 weeks, 6 weeks, 10 weeks and 14 weeks.
Secondary outcome [2] 331518 0
Secondary Outcome 2
Limb measurements recorded by measuring the leg in centimetres from smallest ankle measure to the widest calf measure and the big toe distal to web space.
Timepoint [2] 331518 0
From screening and recruitment recruits will be monitored at 2 weeks, 6 weeks, 10 weeks and 14 weeks.
Secondary outcome [3] 331519 0
Secondary Outcome 3
Adherence to four daily (20 minute) treatments with Electric Stimulation Therapy as automatically recorded by the device during use. Self-reported adherence will be further recorded by participants in a log stored with the Electric Stimulation Therapy device.
Timepoint [3] 331519 0
From screening and recruitment recruits will be monitored at 2 weeks, 6 weeks, 10 weeks and 14 weeks.
Secondary outcome [4] 331737 0
Secondary Outcome 4
Indicative cost indicators will be measured over the duration of the recruits participation in the study.
Timepoint [4] 331737 0
Over all costs will be assessed by number of clinic visits/home visits, duration of visits, wound dressing products used over the 14 weeks the recruit is enrolled in the trail.

Eligibility
Key inclusion criteria
*A person is eligible if they are over 18 years and have a leg ulcer with a confirmed diagnosis of venous, lymphodema or venous/lymphodema ulcer.
*A person is appropriate for best practice treatment (compression therapy).
*The person or carer /guardian is able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Person is unable to or does not have an informal carer/support person able to physically implement the Electric Stimulation Therapy
*Person has an an existing diagnosis of Deep Vein Thrombosis (DVT)
*Person has an implanted cardiac device such as a permanent pace-maker or internal defibrillator.
*Pregnant women
*Person with a diagnosis of an active malignant disease
*Person with a known reaction to adhesives
*Person who is assessed by the attending clinician to be at risk of skin tears upon removal of the adhesive pads as part of the electric stimulation device due to fragile skin.

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)
Allocation will be provided by a centralised, remote randomisation system (online) once written consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation lists will be generated using a random number function in Microsoft excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The trial includes three groups:
Compression therapy and no electric stimulation therapy
Electric stimulation therapy and no compression therapy
Compression therapy and electric stimulation therapy
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/09/2017
Actual
25/05/2017
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
6/12/2019
Actual
Sample size
Target
228
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 7427 0
The Alfred - Prahran
Recruitment hospital [2] 7428 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [3] 7429 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 7430 0
Sunshine Hospital - St Albans
Recruitment hospital [5] 7431 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 11074 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 11075 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 15232 0
3004 - Prahran
Recruitment postcode(s) [2] 15233 0
3052 - Parkville
Recruitment postcode(s) [3] 15234 0
3084 - Heidelberg
Recruitment postcode(s) [4] 15235 0
3021 - St Albans
Recruitment postcode(s) [5] 15236 0
4032 - Chermside
Recruitment postcode(s) [6] 22879 0
7000 - Hobart
Recruitment postcode(s) [7] 22880 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 295492 0
Commercial sector/Industry
Name [1] 295492 0
Bodyflow International Pty, Ltd.
Country [1] 295492 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Address Bundoora, Corner Plenty Road & Kingsbury Drive, Victoria, Australia. 3083
Country Australia
Country
Australia
Secondary sponsor category [1] 294316 0
None
Name [1] 294316 0
none
Address [1] 294316 0
Country [1] 294316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296820 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 296820 0
55 Commercial Road, Prahran, VIC 3181
Australia
Ethics committee country [1] 296820 0
Australia
Date submitted for ethics approval [1] 296820 0
14/11/2016
Approval date [1] 296820 0
05/12/2016
Ethics approval number [1] 296820 0
501/16

Summary
Brief summary
The trial will consider the clinical effectiveness of electrical stimulation therapy compared to or in combination with compression therapy. People with a lower leg ulcers will be recruited into the study. Participates will be randomised to either (1) continue their current compression therapy (control). (2) to use electronic stimulation therapy (intervention) or (3) use both compression therapy and electric stimulation. Participants in the study group involving electrical stimulation therapy will use a portable stimulation device that can be self administered in the home setting 4 times a day daily for 20 minutes per session. The number of wounds that heal and the percentage of wound size change will be monitored for 14 weeks in total. Fortnightly for the first follow up visit and then monthly. The clinical effectiveness of the treatments will be considered as will cost effectiveness.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
Additional sites recruiting for the RCT trial in the community are RDNS (SA), Illawarra Shoalhaven Local Health District (NSW) and Private Hospital Clinic (QLD)

Contacts
Principal investigator
Name 72130 0
A/Prof William McGinuess
Address 72130 0
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Prahran VIC 3181
Country 72130 0
Australia
Phone 72130 0
+ 61 3 94796748
Fax 72130 0
+ 61 3 9533 2104
Email 72130 0
[email protected]
Contact person for public queries
Name 72131 0
Charne Miller
Address 72131 0
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Prahran VIC 3181
Country 72131 0
Australia
Phone 72131 0
+ 61 3 9476 5090
Fax 72131 0
+ 61 3 9533 2104
Email 72131 0
[email protected]
Contact person for scientific queries
Name 72132 0
Charne Miller
Address 72132 0
La Trobe university
Level 4, The Alfred Centre
99 Commercial Road
Prahran VIC 3181
Country 72132 0
Australia
Phone 72132 0
+ 61 3 9476 5090
Fax 72132 0
+ 61 3 9533 2104
Email 72132 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
Participant consent forms, clearly state that no individual data is made available or is identifiable.


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.