Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000345280
Ethics application status
Approved
Date submitted
30/09/2017
Date registered
7/03/2018
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of low voltage monophasic pulsed current and low voltage biphasic pulsed current on pressure ulcer healing based on clinical treatment effects and basic research.
Scientific title
A comparison of the efficacy of monophasic pulsed current and biphasic pulsed current in the treatment of Stage II-IV pressure ulcers. A prospective, randomized, controlled, clinical study.
Secondary ID [1] 293038 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing 304935 0
Pressure ulcer 304936 0
Chronic wound 304937 0
Chronic wound healing 304938 0
Pressure ulcer healing 304939 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304265 304265 0 0
Other physical medicine / rehabilitation
Skin 304266 304266 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim of study
The purpose of this prospective, parallel-group, randomized, blinded, controlled, clinical trial is to compare the healing progress of Stage II-IV pressure ulcers (PU) in adult persons after 8 weeks of intervention involving standard wound care (SWC) plus sham electrical stimulation (ES), SWC in conjunction with low voltage monophasic pulsed current (LVMPC), and SWC in conjunction with low voltage biphasic pulsed current (LVBPC).

Demographic information on the patients will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the patients and the documentation of their concomitant diseases.

The patients’ physical and mental conditions, activity, mobility and incontinence will be assessed using the Norton scale. To assess the possibility of friction, shear, skin moisture, sensory perception of the patients, their physical activity and mobility as well as accompanying diseases affecting the progress of wound healing the Braden and Waterloo Scales will be applied. Patients’ nutritional status will be identified by means of the Nutritional Risk Score (NRS-2002).

Wound severity at enrolment will be assessed based on the National Pressure Ulcer Advisory Panel criteria: Stage II ulcers = partial-thickness loss of the dermis presenting as a shallow open ulcer with a red pink wound bed, without slough; Stage III ulcers = full-thickness tissue loss; subcutaneous fat may be visible but bone, tendon or muscle are not exposed; Stage IV ulcers = full-thickness tissue loss with exposed tendon, muscle or bone. Slough or eschar may be present on some parts of the wound bed. Can include undermining and tunnelling.

SWC programme administered to the experimental groups
All patients will be treated to prevent the development of new PUs. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse or physiotherapist will reposition the immobile patients every 2 hours at the least..

Blood tests will be carried out to screen for nutritional status markers and metabolic disorders such as anaemia, iron deficiency or chronic disease, thyroid dysfunction, impaired glycaemic control, dehydration, protein deficit, hypoalbuminemia.

Wounds will be regularly assessed by the attending physician over the period of the study to select topical treatments appropriately addressing moisture control, bacterial burden,
and debridement needs; microbiological culture and sensitivity tests will also be performed.

A team formed of a physician, a nurse, a physical therapist and a dietician will make comprehensive, interdisciplinary assessments of the patients to develop SWC programmes meeting their specific demands, for instance consisting of nutritional intervention, optimization of the wound dressing protocol, and incontinence management. The clinician caregivers will be blinded to participant’s group.

Patients will receive similar standard topical care, selected to address their individual needs.
All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy.

Electrical stimulation with LVMPC
In the LVMPC group, patients will be administered LVMPC in addition to SWC. The device for applying MPC will be the Intelect Advanced Combo (by Chattanooga, USA) generating a rectangular, monophasic pulses with duration of 100 microseconds and frequency of 100 pps. A current of 36 mA will be set, which allows applying 360 microcoulomb per second to tissues.

Each patient will have their own set of electrodes made of conductive carbon rubber.
The treatment electrode (60 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (60 cm2) closing the electrical circuit will be positioned at least 20 cm from the PU. Before and after each ES procedure, the electrodes will be sterilized in a disinfectant solution. Pressure ulcers will be stimulated with both cathode and anode. The polarization of the treatment electrode will be changed weekly, with treatment beginning with cathodal stimulation.

Electrical stimulation with LVBPC
In the LVBPC group, patients will be administered LVBPC in addition to SWC. The device for applying LVBPC will be the TrioStim 215 (by Mettler Electronics, USA) generating a rectangular, biphasic pulses with duration of 100 microseconds and frequency of 100 pps. A current of 36 mA will be set, which allows applying 360 microcoulomb per second to tissues.

Each patient will have their own set of electrodes made of conductive carbon rubber.
The treatment electrode (60 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (60 cm2) closing the electrical circuit will be positioned at least 20 cm from the PU. Before and after each ES procedure, the electrodes will be sterilized in a disinfectant solution. .

In both ES groups ES will be applied by physiotherapist for 50 minutes a day, 5 days a week (Monday-Friday) for a period of 8 weeks (40 ES sessions), during which wounds will be observed for healing progress.

In both ES groups all ES procedures will be accurately described by the physiotherapist performing them. The description will include: frequency of treatments per week, duration of treatment and current intensity. The accuracy of ES procedures performed at individual facilities at least once a week will be controlled by the study manager.

Participation (presence) of the patient on each ES will be recorded in a special journal kept by the main therapist in each of the centers that participate in the study. The diary will record whether the ES procedure was performed on a given day and whether it lasted 60 minutes. Performing ES treatments will be controlled by the manager of a given center. After the end of each week of therapy, the main therapist in the center will send an electronic report of the performed procedure to the study manager.
Intervention code [1] 299259 0
Rehabilitation
Intervention code [2] 299260 0
Treatment: Devices
Intervention code [3] 299261 0
Treatment: Other
Comparator / control treatment
The control group will be administered the same SWC programme as the experimental groups.

All patients will be treated to prevent the development of new PUs. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse or physiotherapist will reposition the immobile patients every 2 hours at the least.

Blood tests will be carried out to screen for nutritional status markers and metabolic disorders such as anaemia, iron deficiency or chronic disease, thyroid dysfunction, impaired glycaemic control, dehydration, protein deficit, hypoalbuminemia.

Wounds will be regularly assessed by the attending physician over the period of the study to select topical treatments appropriately addressing moisture control, bacterial burden,
and debridement needs; microbiological culture and sensitivity tests will also be performed.

A team formed of a physician, a nurse, a physical therapist and a dietician will make comprehensive, interdisciplinary assessments of the patients to develop SWC programmes meeting their specific demands, for instance consisting of nutritional intervention, optimization of the wound dressing protocol, and incontinence management.

The clinician caregivers will be blinded to participant’s group.

All Patients will receive similar standard topical care, selected to address their individual needs.

All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy.

Sham ES
In addition to standard wound care described above, the control group will also receive
sham ES. The electrodes will be arranged in the same way as in the ES groups and all current parameters will also be displayed on the monitor but the current itself will not be applied. Sham ES procedures will be applied by physiotherapist with the same ES devices as in the ES groups.

Sham ES sessions will have the same duration and frequency (50-minute sessions; five times a week, for 8 weeks) as active ES procedures.

In the control group all sham ES procedures will be accurately described by the physiotherapist performing them. The description will include: frequency of treatments per week, duration of treatment and current intensity. Performing sham ES treatments will be additionally controlled by the manager of a given center (who will not know if ES is active or sham). The accuracy of ES procedures performed at individual facilities at least once a week will be controlled by the study manager.
Control group
Placebo

Outcomes
Primary outcome [1] 303546 0
Absolute average change in wound surface area (WSA) (cm2) after treatment in relation to its baseline in all groups (showing how effective treatment will be in particular groups).
WSA will be determined using the same method that was already employed in several previous clinical trials. First wound contours will be copied onto transparent film sheets. The contours will be then measured with the planimeter to establish the surface area of each wound. The obtained data will be processed by a digitizer (Mutoh Kurta XGT, Altek, USA) connected to a personal computer (C-GEO v. 4.0 Nadowski, PL) which will be also used to store the results.
Timepoint [1] 303546 0
At baseline, week 2, week 4, week 6, and week 8
Primary outcome [2] 303547 0
Changes in skin and subcutaneous tissue showing healing progress visible on ultrasound (15 - 20 MHz) imaging. Ultrasonographic findings were reviewed for the presence of four types of ultrasound features that signify deep tissue injury: unclear layered structure, hypoechoic lesion, discontinuous fascia and heterogeneous hypoechoic area.
Timepoint [2] 303547 0
At baseline, week 2, week 4, week 6, and week 8
Secondary outcome [1] 339297 0
Thermal skin changes in the wound area will be evaluated with non-invasive method using a thermal imaging camera. .
Timepoint [1] 339297 0
At baseline, week 2, week 4, week 6 and week 8
Secondary outcome [2] 339298 0
Changes in skin blood flow (SBF) in the wound area after 2, 4, 6 and 8 weeks of treatment in relation to its baseline in all groups (to compare changes in SBF between the groups). SBF will be measured using a laser Doppler imager (PERIFLUX 5000; Perimed; Sweden)
Timepoint [2] 339298 0
At baseline, week 2, week 4, week 6, and week 8
Secondary outcome [3] 339299 0
Changes in the concentration of pro-inflammatory cytokines in wound fluid (IL-1Beta, IL-6, TNFalpha).
Timepoint [3] 339299 0
At baseline, week 2, week 4, week 6, and week 8
Secondary outcome [4] 339300 0
Changes in the concentration of anti-inflammatory cytokines in wound fluid (IL-10).
Timepoint [4] 339300 0
At baseline, week 2, week 4, week 6, and week 8
Secondary outcome [5] 339301 0
Changes in the concentration of metalloproteinases in wound fluid (MMP-2, MMP-3, MMP-9).
Timepoint [5] 339301 0
At baseline, week 2, week 4, week 6, and week 8
Secondary outcome [6] 339302 0
Changes in the concentration of growth factors in wound fluid (FGF; IGF-1; VEGF, EGF, KGF, TGF beta1).
Timepoint [6] 339302 0
At baseline, week 2, week 4, and week 8

Eligibility
Key inclusion criteria
Patient eligibility for the study will be established by their physician as per the following criteria: a) patients older than 18 years of age; b) hospitalized in care and therapeutic centers; c) with Category II, III or IV pressure ulcer of at least 0.5 cm2 in size and of duration of at least 4 weeks; d) at least average risk of pressure ulcer development (Waterloo score equal to or greater than 10 points).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients who are not qualify for ES (cancer, electronic implants and osteomyelitis in the pressure ulcer area) will be excluded from participating, as well as those with diagnoses that might interfere with wound healing, particularly diabetes (HbA1C greater than 7%), diabetic neuropathy, critical infection and alcoholism.

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)
The selected patients (or their legal guardians) who will give their consent to participate in the study will be randomly assigned to the control group (SWC plus sham ES), the LVMPC group (SWC plus LVMPC) or the LVBPC group (SWC plus LVBPC) using a concealed proces. Allocation will be concealed by sealed opaque envelopes.

Patient allocation to groups will be independent of when and who will deliver the treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group assignment will be performed using the block randomization method. In each of the three centers incuded in the study, a person uninvolved in the trial will generate 4 blocks of 6 letters (combinations of A, B, and C) using computer software. To conceal the allocation sequence, consecutively numbered, opaque, and sealed envelopes will be used. The principal investigator (study manager) will open tchem to assign patients to the appropriate group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All patients in the study will be assessed for the homogeneity of distribution of their characteristics (age, BMI, concomitant diseases, malnutrition, presence of ultrasound features that signify deep tissue injury, temperature in the wound area, wound and periwound skin blood flow, concentration of cytokines, growth factors and metalloproteinases, etc.).

Depending on the distribution of variables, statistical analysis of the results will be performed using either parametric or nonparametric tests. Between the groups will be compared: presence of signs of tissue damage visible by ultrasonography, changes in temperature in the area of wounds, changes in blood flow in the area of wounds and in the skin around the wounds, changes in concentration of cytokines, growth factors and metalloproteinases.

The level of statistical significance in all tests will be p < 0.05.

The statistical analysis will be performed using the Statistica software by StatSoft (licensed to the Academy of Physical Education in Katowice).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2018
Actual
26/03/2018
Date of last participant enrolment
Anticipated
4/02/2019
Actual
Date of last data collection
Anticipated
1/04/2019
Actual
Sample size
Target
72
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 9251 0
Poland
State/province [1] 9251 0
Silesia

Funding & Sponsors
Funding source category [1] 297650 0
University
Name [1] 297650 0
Academy of Physical Education
Country [1] 297650 0
Poland
Primary sponsor type
University
Name
Academy of Physical Education
Address
Mikolowska 72A, 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 296671 0
None
Name [1] 296671 0
Address [1] 296671 0
Country [1] 296671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298734 0
The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 298734 0
Ethics committee country [1] 298734 0
Poland
Date submitted for ethics approval [1] 298734 0
Approval date [1] 298734 0
18/05/2017
Ethics approval number [1] 298734 0

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

Contacts
Principal investigator
Name 78058 0
Dr Anna Polak
Address 78058 0
Department of Physical Therapy, Academy of Physical Education,
Mikolowska 72A street, 40-065 Katowice
Country 78058 0
Poland
Phone 78058 0
+48322075129
Fax 78058 0
+48322075318
Email 78058 0
[email protected]
Contact person for public queries
Name 78059 0
Anna Polak
Address 78059 0
Department of Physical Therapy, Academy of Physical Education,
Mikolowska 72A street, 40-065 Katowice
Country 78059 0
Poland
Phone 78059 0
+48322075129
Fax 78059 0
+48322075318
Email 78059 0
[email protected]
Contact person for scientific queries
Name 78060 0
Anna Polak
Address 78060 0
Department of Physical Therapy, Academy of Physical Education,
Mikolowska 72A street, 40-065 Katowice
Country 78060 0
Poland
Phone 78060 0
+48322075129
Fax 78060 0
+48322075318
Email 78060 0
[email protected]

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