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Trial registered on ANZCTR


Registration number
ACTRN12617001534370
Ethics application status
Approved
Date submitted
20/09/2017
Date registered
6/11/2017
Date last updated
6/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of pulsed currents applied by cathode and anode in the treatment
of category I pressure ulcers.
Scientific title
Comparison of healing progress of category I pressure ulcers undergoing cathodal
and anodal electrical stimulation with pulsed currents in adult persons. A pilot, randomized, controlled, clinical study.
Secondary ID [1] 292944 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure ulcer
 304834 0
Chronic wounds
 304835 0
Condition category
Condition code
Skin 304135 304135 0 0
Dermatological conditions
Physical Medicine / Rehabilitation 304136 304136 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 304137 304137 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this pilot, parallel-group, randomized, blinded, controlled clinical trial is to compare the healing progress of category I pressure ulcers (PUs) in adult people after minimum of 2 weeks of intervention involving standard wound care (SWC), SWC in conjunction with monophasic pulsed current (MPC) delivered by the cathode, and SWC combined with MPC delivered by the anode as the treatment electrodes.

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: Category I pressure ulcers = intact skin with non-blanchable redness of a localized area usually over a bony prominence. The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue.

SWC programme administered to both 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 in all groups 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 the cathode
In the cathodal ES group, patients will be administered MPC 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 (0.72 mA / cm2) 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 (50 cm2) will be placed on an aseptic gauze pad saturated with physiological saline overlaying the wound site. The dispersive electrode (50 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. Over the period of the intervention, the negative electrode (cathode) will be used to treat PUs. This MPC protocol has been selected because of the positive results of earlier clinical trials on patients with PUs and venous leg ulcers.

Electrical stimulation with the anode
Patients in the anodal ES group will receive MPC in the same way as patients in the cathodal ES group, but the treatment electrode will be the anode.

MPC with the cathode (in the cathode ES group) and with the anode (in the anode ES group) will be applied for 45 minutes a day, for a period of minimum 2 weeks (minimum 10 MPC sessions), during which wounds will be observed for healing progress.
Intervention code [1] 299181 0
Treatment: Devices
Intervention code [2] 299182 0
Rehabilitation
Comparator / control treatment
Control group
The control group will be administered the same SWC programme as both 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.

All sham and active ES sessions will have the same duration and frequency (45-minute sessions; five times a week, for minimum two weeks).
Control group
Placebo

Outcomes
Primary outcome [1] 303454 0
Changes in skin 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 [1] 303454 0
At baseline, week 1 and week 2.
Secondary outcome [1] 338971 0
Thermal skin changes in the wound area will be evaluated with non-invasive method using a thermal imaging camera. Combination of the thermographic and ultrasonographic assessment showed that deep tissue injures simultaneously harboured high temperature and heterogeneous hypoechoic areas, whereas non-deep tissue injury cases were not simultaneously associated with these two findings.
Timepoint [1] 338971 0
At baseline, week 1 and week 2
Secondary outcome [2] 338972 0
Changes in skin blood flow (SBF) on the wound area after 1 and 2 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] 338972 0
At baseline, week 1 and week 2.

Eligibility
Key inclusion criteria
Patient eligibility for the study will be established by their physician as per the following criteria: a) older than 18 years of age; b) patient hospitalized in a hospital ward; c) a Category I pressure ulcer; 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, 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 cathode MPC group (SWC plus cathode MPC) or the anode MPC group (SWC plus anode MPC) using a concealed process.

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)
The group allocation sequence will be concealed. Simple randomisation with numbered envelopes will be used.

An independent person will receive three batches of 20 pieces of paper, each marked with a letter indicating to which group the patient should go, i.e. A for the SWC+cathodal MPC group, B for the SWC+anodal MPC group and C for the SWC+sham ES group. The person, unaware of what the symbols mean, will insert the pieces of paper into 60 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.
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 experiment 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 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 and changes in blood flow in the area of wounds and in the skin around the wounds.

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
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2017
Actual
Date of last participant enrolment
Anticipated
3/09/2018
Actual
Date of last data collection
Anticipated
17/09/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 9225 0
Poland
State/province [1] 9225 0

Funding & Sponsors
Funding source category [1] 297571 0
University
Name [1] 297571 0
Academy of Physical Education
Country [1] 297571 0
Poland
Primary sponsor type
University
Name
Academy of Physical Education
Address
Mikolowska 72A
40-065 Katowice
Country
Poland
Secondary sponsor category [1] 296583 0
None
Name [1] 296583 0
Address [1] 296583 0
Country [1] 296583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298665 0
The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 298665 0
Ethics committee country [1] 298665 0
Poland
Date submitted for ethics approval [1] 298665 0
20/03/2017
Approval date [1] 298665 0
18/05/2017
Ethics approval number [1] 298665 0
4/2017 of 18 May 2017

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

Contacts
Principal investigator
Name 77822 0
Dr Anna Polak
Address 77822 0
Department of Physical Therapy
Academy of Physical Education
Mikolowska 72A
40-065 Katowice
Country 77822 0
Poland
Phone 77822 0
+48322075129
Fax 77822 0
+48322075318
Email 77822 0
a.polak@awf.katowice.pl
Contact person for public queries
Name 77823 0
Anna Polak
Address 77823 0
Department of Physical Therapy
Academy of Physical Education
Mikolowska 72A
40-065 Katowice
Country 77823 0
Poland
Phone 77823 0
+48322075129
Fax 77823 0
+48322075318
Email 77823 0
a.polak@awf.katowice.pl
Contact person for scientific queries
Name 77824 0
Anna Polak
Address 77824 0
Department of Physical Therapy
Academy of Physical Education
Mikolowska 72A
40-065 Katowice
Country 77824 0
Poland
Phone 77824 0
+48322075129
Fax 77824 0
+48322075318
Email 77824 0
a.polak@awf.katowice.pl

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

Documents added manually
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Documents added automatically
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