Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000249651
Ethics application status
Not yet submitted
Date submitted
27/02/2014
Date registered
10/03/2014
Date last updated
10/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study: Do Wounds Heal Faster When Using Electric Stimulation Therapy
Scientific title
A single blinded randomised controlled trial to determine the clinical effect size and client concordance following eight weeks using a portable electrostimulation device among people with an active leg ulcer who do not tolerate moderate to high compression therapy
Secondary ID [1] 284169 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcers 291174 0
Condition category
Condition code
Skin 291512 291512 0 0
Other skin conditions
Physical Medicine / Rehabilitation 291674 291674 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be instructed to self-administer Electrostimulation Therapy using a small portable device four times daily for 20 minute sessions, over a period of 8 weeks. The device will be pre-set to a single, non-adjustable specific low frequency found between 1-2 Hertz, a current that specifically targets smooth muscle to promote stimulation of arterial, venous and lymphatic systems. Adherence will be monitored using a self-report participant treatment log.
Intervention code [1] 288794 0
Treatment: Devices
Comparator / control treatment
Both control and active intervention groups will continue the standard treatment they are currently using: no compression or low compression therapy (<18mmHg; light or extra light compression).
Participants allocated to the control group will use the Electrostimulation Therapy as recommended for the same duration and mode of administration as the intervention group. Participants in the control group will however be provided with placebo devices that although they appear to be operational, the circuit to deliver the Electrostimulation will be non-operational.
Control group
Placebo

Outcomes
Primary outcome [1] 291483 0
Wound healing rate for the ‘study wound’ (determined as a daily healing rate from total wound surface tracings quantified using VisiTrak tracings and VisiTrak annotating board)
Timepoint [1] 291483 0
Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.
Secondary outcome [1] 306879 0
Number of wounds healed in study timeframe / date wound healed
Timepoint [1] 306879 0
Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.
Secondary outcome [2] 306880 0
Limb volume measured using water displacement method or water plethysmography
Timepoint [2] 306880 0
Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.
Secondary outcome [3] 306881 0
Limb measurements recorded in centimetres of smallest ankle, widest calf, and big toe distal to web space
Timepoint [3] 306881 0
Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.
Secondary outcome [4] 306882 0
Adherence to four daily (20 minute) treatments of electrostimulation Therapy. Adherence will be self-reported in a log stored with Electrostimulation Therapy device.

Data will be reported as:
1. Total time (minutes) implementing Electrostimulation Therapy per week during the assessment period, and in total.
2. Proportion of time implementing the Electrostimulation Therapy as per the recommended treatment regimen per week during the assessment period, and in total.
Timepoint [4] 306882 0
Adherence will be self-reported daily in the treatment log and confirmed with researchers weekly after intervention commencement.
Secondary outcome [5] 306883 0
Wound pain assessed using an 11 point Numeric Rating Scale (NRS) (0=no pain to 10 the most pain imaginable)
Timepoint [5] 306883 0
Baseline, and at 2, 4, 6 and 8 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Client has an existing leg ulcer with either primary venous or lymphedema as its primary aetiology
2. Client is appropriate for, and the best practice treatment would involve the highest compression therapy available (+40mmHg)
3. Client is currently using (1) no compression therapy or (2) low compression therapy (less than 18mmHg)
4. Client has received wound care education specifically promoting the use of compression therapy
5. The client or carer/legal guardian is able to provide informed consent to participate in the study
6. Client has had a Doppler ultrasound in the last 12 weeks
7. Ankle Pressure Brachial Index is between greater than or equal to 0.8 and less than or equal to 1.2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Client is using moderate or high compression therapy (equal to or greater than 18mmHg) for any period of the day for one or more days of the week.
2. Client is unable to or does not have someone who can physically implement the Electrostimulation Therapy.
3. Client is unable to or does not have someone who can take low compression garments (for those currently wearing compression) on and off in between Electrostimulation Therapy treatments
4. Client has an existing diagnosis of Deep Vein Thrombosis (DVT)
5. Client has an implanted cardiac device such as a permanent pace-maker or internal defibrillator
6. Diagnosed with an active malignant disease
7. Client is pregnant
8. Client has signs of clinical infection in their ulcer
9. Client has a known reaction to adhesive chemicals such as those used on dressings
10. Client is assessed by their clinician as having fragile skin that is at risk of damage when removing the adhesive pads
11. Client has one of the following medical diagnoses: hypothyroidism, hyperthyroidism, congestive cardiac failure, or hypertension

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation lists will be generated for each setting and will be stratified by participants use of compression bandaging using a random number function in Microsoft excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
As Electrostimulation Therapy generates sensation to the leg, to mask the placebo devices study participants will be advised that some people do, and some people do not, feel sensation when using the Electrostimulation device.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was not drawn from a power analysis rather it is an indicative sample to enable determination of an effect size.
Data collected will be entered directly into SPSS database. A 10 per cent validation of all data will be undertaken. Generation of effect sizes will be based on two-way repeated measures analysis of variance tests for wound healing rate. Analysis will be in accordance with intention to treat with additional consideration of a “complete case” analysis. A “modified intention-to-treat” analysis will also be conducted to indicate of the effects associated with the treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2014
Actual
Date of last participant enrolment
Anticipated
25/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2093 0
The Alfred - Prahran
Recruitment hospital [2] 2094 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 7778 0
3181 - Prahran
Recruitment postcode(s) [2] 7779 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 288733 0
Commercial sector/Industry
Name [1] 288733 0
BodyFlow International Pty Ltd
Country [1] 288733 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BodyFlow International Pty Ltd
Address
Unit 1, 297 Ingles Street, Port Melbourne, Vic, 3207
Country
Australia
Secondary sponsor category [1] 287494 0
None
Name [1] 287494 0
Address [1] 287494 0
Country [1] 287494 0
Other collaborator category [1] 277828 0
University
Name [1] 277828 0
La Trobe University
Address [1] 277828 0
La Trobe Clinical School, Level 4, The Alfred Centre, 99 Commercial Road, Prahran, VIC, 3004
Country [1] 277828 0
Australia
Other collaborator category [2] 277829 0
Hospital
Name [2] 277829 0
Alfred Health
Address [2] 277829 0
Level 4, The Alfred Centre, 99 Commercial road, Prahran, VIC, 3004
Country [2] 277829 0
Australia
Other collaborator category [3] 277830 0
Hospital
Name [3] 277830 0
Austin Health
Address [3] 277830 0
Heidelberg Repatriation Hospital, PO BOX 5444, Heidelberg West, VIC, 3081
Country [3] 277830 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290568 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 290568 0
Human Research Ethics Committee (HREC), Governance & Low & Negligible Risk Research (LNRR)
P.O Box 5555 Heidelberg 3084
Ethics committee country [1] 290568 0
Australia
Date submitted for ethics approval [1] 290568 0
20/02/2014
Approval date [1] 290568 0
Ethics approval number [1] 290568 0
Ethics committee name [2] 290642 0
Alfred Health Human Research Ethics Commitee
Ethics committee address [2] 290642 0
The Alfred
55 Commercial Road
Prahran, Vic, 3004
Ethics committee country [2] 290642 0
Australia
Date submitted for ethics approval [2] 290642 0
24/02/2014
Approval date [2] 290642 0
Ethics approval number [2] 290642 0

Summary
Brief summary
Leg ulcers have a big impact on the lives of those affected. Compression therapy is recommended to help heal an ulcer but many people find it difficult to wear high or moderate compression therapy products. Electric stimulation therapy has been used by physiotherapists to improve circulation in the legs—the goal of compression therapy. This study has been developed as a small clinical trial that will see if electric stimulation therapy can help heal ulcers and will help determine if further large clinical trials are worthwhile.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46282 0
A/Prof William McGuiness
Address 46282 0
Level 4, The Alfred Centre, 99 Commercial road, Prahran, VIC, 3004
Country 46282 0
Australia
Phone 46282 0
+61 3 9479 6743
Fax 46282 0
Email 46282 0
[email protected]
Contact person for public queries
Name 46283 0
Ms Charne Miller
Address 46283 0
Level 4, The Alfred Centre, 99 Commercial road, Prahran, VIC, 3004
Country 46283 0
Australia
Phone 46283 0
+61 421047911
Fax 46283 0
Email 46283 0
[email protected]
Contact person for scientific queries
Name 46284 0
Ms Charne Miller
Address 46284 0
Level 4, The Alfred Centre, 99 Commercial road, Prahran, VIC, 3004
Country 46284 0
Australia
Phone 46284 0
+61 421047911
Fax 46284 0
Email 46284 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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