Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000992606
Ethics application status
Approved
Date submitted
5/08/2014
Date registered
15/09/2014
Date last updated
27/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The healing of pressure ulcers treated with electrical stimulation delivered by the cathode versus the alternating use of the cathode and anode.
Scientific title
The healing of pressure ulcers in geriatric patients treated with high voltage pulsed current delivered by the cathode versus the alternating use of the cathode and anode. A prospective, randomized, controlled, clinical study
Secondary ID [1] 285090 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing

 292629 0
Pressure ulcers 292631 0
Chronic wound healing
292633 0
Pressure ulcer healing 292739 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292947 292947 0 0
Physiotherapy
Physical Medicine / Rehabilitation 292948 292948 0 0
Other physical medicine / rehabilitation
Skin 293032 293032 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, controlled, clinical trial is to compare the healing progress of pressure ulcers (PU) in geriatric people after 6 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage pulsed current (HVPC) delivered by the cathode, and SWC combined with HVPC delivered by the cathode and the anode as the treatment electrodes.

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

The patients’ physical and mental conditions, activity, mobility and incontinence will be assessed using the Norton scale (a score < 14 indicated a high risk of PU development). To assess the possibility of friction and shear and wound moisture, as well as sensory perception of the patients, their physical activity and mobility the Braden Scale will be applied (a score < 16 pointed to a high risk of PU development). 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 and European 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 eposed tendom, muscle or bone. Slough or eschar may be present on some parts of the wound bed. Can include unermining and tunneling.


SWC programme administered to all groups.

All patients will be treated to prevent the development of new pressure ulcers. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse 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 anaemia or anaemia of 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 in all groups will receive similar standard topical care, selected to address their individual needs and to promote moist interactive healing.

All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy. Patients with elevated leukocyte levels will be treated with antibiotics selected following microbiological culture and sensitivity testing of the PU swab.



Electrical stimulation with the cathode

In the cathode HVPC group, patients will be administered HVPC in addition to SWC.

The device for applying HVPC will be the Intelect Advanced Combo (by Chattanooga, USA). The device generates a twin-peak monophasic pulse consisting of two 77- microseconds exponential pulses in rapid succession (the twin-peak pulse duration was 154 microseconds). Pulse frequency will be 100 pps. Current intensity will be set within 0.25-0.30 A, so patients will only experience sensory effects (without motor reactions). Voltage will be set to 100 V and the electrodes will deliver an electrical charge of 250 microcoulomb per second. This HVPC protocol has been selected because of the positive results of earlier clinical trials on patients with pressure ulcers (Pus) and venous leg ulcers (VLUs).

Each patient will have their own set of electrodes made of conductive carbon rubber. The treatment electrode (of a size matching the wound surface area) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (bigger than the treatment electrode) closing the electrical circuit will be positioned about 20 cm from the PU (proximally or distally, depending on where the PU developed).

Over the period of the intervention, the negative electrode (cathode) will be used to treat pressure ulcers. The authors of some other clinical studies on PUs have also used cathodal stimulations.

In the experiment, five 50-minute sessions will be held per week (one a day), following the approach adopted by other authors.

Pressure ulcers receiving SWC and cathode HVPC will be monitored for healing progress for 6 weeks or until wounds close, whichever occurs first.




Electrical stimulation with the cathode and the anode

Patients in the cathode/anode HVPC group will receive HVPC in the same way as patients in the cathode HVPC group, but first the cathode will be applied as the treatment electrode to stimulate the growth of granulation tissue. Cathodal stimulation will be used in week 1 (5 days) and then it will be replaced by anodal stimulation for the remainder of the experiment. The authors of other clinical studies on VLUs and PUs used the same sequence of cathodal and anodal stimulation.

Before and after each ES procedure, the electrodes will be sterilized in a disinfectant solution. Pressure ulcers will be thoroughly cleansed with a 0.9% sodium chloride solution and covered with the earlier described dressings immediately after the procedure.

Pressure ulcers receiving SWC and cathode/anode HVPC will be monitored for healing progress for 6 weeks or until wounds close, whichever occurs first.

Intervention code [1] 289956 0
Rehabilitation
Intervention code [2] 289999 0
Treatment: Devices
Comparator / control treatment
Control group
Patients in the control group will be treated to prevent the development of new pressure ulcers. Pressure-redistribution surfaces, devices and pillows will be applied as needed. A nurse 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 anaemia or anaemia of 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 and to promote moist interactive healing. All immobilized patients will receive low-molecular-weight heparin (enoxaparin) as a standard therapy. Patients with elevated leukocyte levels will be treated with antibiotics selected following microbiological culture and sensitivity testing of the PU swab.


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. Five 50-minute sessions of sham ES will be held per week (one a day).


Pressure ulcers receiving SWC in the control group will be monitored for healing progress for 6 weeks or until wounds close, whichever occurs first.
Control group
Active

Outcomes
Primary outcome [1] 292829 0
Absolute average change in 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. Measurement errors caused by different shapes of the wounds may range from 2.7% (for pressure ulcers of 60 to 70 cm2 in size) to 37.9% (for pressure ulcers < 1 cm2). The method with which measurement errors will be calculated can be found in our earlier study.
Timepoint [1] 292829 0
At baseline, and week6
Primary outcome [2] 292830 0
The percentage change/decrease in WSA after 6 weeks of intervention with SWC + sham ES, SWC + cathode HVPC, and SWC + cathode/anode HVPC (to compare changes in PU surface area between the groups).

The formula for calculating percentage WSA reduction from baseline (%WSA) will be the following:
%WSA = initial WSA (cm2) – WSA (cm2) at week 6 x 100% / Initial WSA (cm2)
Timepoint [2] 292830 0
At baseline, and week 6
Secondary outcome [1] 309766 0
The Gilman's parameter calculated to ensure the comparability of healing progress regardless of wound shape

The Gilman's parameter (GP) will be calculated as:

GP= S / p
S = (Si - Sf)
Si, Sf - initial and final wound surface areas
p = (pi + pf) / 2
pi, pf - initial and final wound perimeter
Timepoint [1] 309766 0
At baseline, and week 6
Secondary outcome [2] 309767 0
Wound healing rates presenting average weekly relative change in wound area (%/week) calculated to compare the groups.

The weekly relative change in ulcer area (%/week) will be calculated as:
%/week = Percentage change in WSA (%WSA) / Total number of weeks of treatment
Timepoint [2] 309767 0
At baseline, and week 6
Secondary outcome [3] 309768 0
Percentage change in WSA will be assessed after each week of treatment to find out in which week the change was the greatest.

The following formulas will be used to this end:

%WSAweek1= initial WSA (cm2) – WSA (cm2) at week1 x100% / Initial WSA (cm2)

%WSAweek2= WSA(cm2) at week1 – WSA(cm2) at week2 x100% / WSA(cm2) at week1

%WSAweek3= WSA(cm2) at week2 – WSA (cm2) at week3 x100% / WSA(cm2) at week2

%WSA/week4= WSA(cm2) at week3 – WSA (cm2) at week4
x100% / WSA(cm2) at week3

%WSA/week5= WSA(cm2) at week4 – WSA (cm2) at week5
x100% / WSA(cm2) at week4

%WSA/week6= WSA(cm2) at week5 – WSA (cm2) at week6
x100% / WSA(cm2) at week5
Timepoint [3] 309768 0
At baseline, week1, week2, week3, week4, week5, and week6
Secondary outcome [4] 309769 0
The percentage of PUs the WSA of which will be significantly smaller at the end of week 6 of intervention (by at least 50%), that will heal completely or will increase (WSA greater than the baseline).
Timepoint [4] 309769 0
At baseline, and week6

Eligibility
Key inclusion criteria
Patient eligibility for the experiment will be established by their physician according to the following criteria: older than 60 years of age, at high risk of PU development (a score on the Norton scale below 14 points), with a stage II, III or IV pressure ulcer of at least 0.5 cm2 in size and of minimal duration 4 weeks.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition that might prevent the application of electrical stimulation (ES) (a cardiac pacemaker, cancer, osteomyelitis, PU in need of surgical intervention).

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)
Patient eligibility for the experiment will be established by their physician. 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 cathode HVPC group (SWC plus cathode HVPC) or the cathode/anode HVPC group (SWC plus cathode/anode HVPC) using a concealed process.

Patient distribution among groups will be independent of when and who will deliver the treatment. An independent person will receive three batches of 25 pieces of paper, each marked with a letter indicating to which group the patient should go, i.e. A for the SWC+cathodal HVPC group, B for the SWC+cathodal/anodal HVPC group and C for the SWC+sham ES group. The person, unaware of what the symbols mean, will insert the pieces of paper into 75 envelopes randomly drawn by the computer. The sealed envelopes will be transferred to the main investigator in charge of patients’ allocation to groups.

Before the treatment, the envelopes will be opened one-by-one in the presence of a physiotherapist and the patient concerned will be directed to the appropriate study group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using numbered envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
To determine group sizes for the experiment, a pilot study was carried out. Because the results obtained with the random pilot sample had unimodal distribution and skewness and flatness were smaller than 2.5, the arithmetic average and standard deviation were chosen for the experiment as good measures of central value and dispersion.

Based on type I error, probability a = 0.05 and test power 1-beta = 0.90 were accepted for the experiment. An assumption was made that to assess wound healing progress in each group, the minimum statistically significant difference would be set at 25% of the baseline. According to the assumptions, a group in the experiment should have at least 20 patients (60 patients in three groups), but the actual size of the sample will be increased to 75 randomly selected patients to allow for possible dropouts. Statistical calculations were performed using the „Statistica” 10 package

After the experiment, patients’ characteristics will be tested for normality of distribution using the Shapiro-Wilk W test.
In the case of normal distributions, the parametric ANOVA test will be used, and in the case of non-normal distributions, the non-parametric tests (Kruskal-Wallis analysis of variance for inter-group comparisons and Friedman’s ANOVA for intragroup comparisons) will be used to establish statistical significance.

Patients’ characteristics will also be tested for skewness, kurtosis and modality of distributions. In the cases when skewness and kurtosis are smaller than 4 and the distributions are unimodal, arithmetic averages and standard deviations will be used as the measures of central value and dispersion.

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 (licenced to the Medical University of Silesia).

All patients in the experiment will be assessed for the homogeneity of distribution of their characteristics.
The mean wound surface area (WSA) before and after treatment will be compared within particular groups. The mean percentage change in wound area, the value of the Gilman’s parameter and mean weekly change in WSA will be calculated (at week 6) in all groups and then an inter-group comparison will be performed. At the end of intervention (week 6), the healing rates of PUs that have significantly improved (decreasing by at least 50%), closed or worsened (i.e. having WSA greater than baseline) will be calculated and compared between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2014
Actual
22/09/2014
Date of last participant enrolment
Anticipated
27/02/2015
Actual
27/04/2015
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
71
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 6273 0
Poland
State/province [1] 6273 0
Silesia

Funding & Sponsors
Funding source category [1] 289714 0
University
Name [1] 289714 0
Academy of Physical Education
Country [1] 289714 0
Poland
Primary sponsor type
University
Name
Academy of Physical Education,
Address
Academy of Physical Education,
Department of Physical Therapy,
Mikolowska 72A street
40-065 Katowice
Country
Poland
Secondary sponsor category [1] 288408 0
None
Name [1] 288408 0
Address [1] 288408 0
Country [1] 288408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291452 0
The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 291452 0
Ethics committee country [1] 291452 0
Poland
Date submitted for ethics approval [1] 291452 0
02/04/2014
Approval date [1] 291452 0
15/05/2014
Ethics approval number [1] 291452 0
4/2014

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

Contacts
Principal investigator
Name 50370 0
Dr Anna Polak
Address 50370 0
Department of Physical Therapy,
Academy of Physical Education,
Mikolowska 72A street,
40-065 Katowice
Country 50370 0
Poland
Phone 50370 0
+48322075129
Fax 50370 0
Email 50370 0
[email protected]; [email protected]
Contact person for public queries
Name 50371 0
Anna Polak
Address 50371 0
Department of Physical Therapy,
Academy of Physical Education,
Mikolowska 72A street,
40-065 Katowice
Country 50371 0
Poland
Phone 50371 0
+48322075129
Fax 50371 0
Email 50371 0
[email protected]; [email protected]
Contact person for scientific queries
Name 50372 0
Anna Polak
Address 50372 0
Department of Physical Therapy,
Academy of Physical Education,
Mikolowska 72A street,
40-065 Katowice
Country 50372 0
Poland
Phone 50372 0
+48322075129
Fax 50372 0
Email 50372 0
[email protected]; [email protected]

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