Effect of cathodal and anodal electrical stimulation on pressure ulcer healing

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001709437
• Date of registration: 13/12/2016
• Prospective Registration: No
• Primary sponsor: Academy of Physical Education
• Public title: Effect of cathodal and anodal electrical stimulation on pressure ulcer healing
• Scientific title: Evaluation of the effect of cathodal and anodal electrical stimulation on pressure ulcer healing in people with central nervous system injuries. A prospective, randomized, double-blind, controlled, clinical study
• Date of first enrolment: 04/01/2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001709437.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Dr Anna Polak

• Name: Dr Anna Polak

Key inclusion & exclusion criteria

Inclusion criteria: Patient eligibility for the experiment will be established by their physician according to the following criteria: patients with either paraplegia or quadriplegia caused by congenital, medical, or traumatic central nervous system injury, over the age of 18 years, hospitalized in rehabilitation centre, with a Category II, III or IV PU of at least 0.5 cm2 in size and of minimal duration 4 weeks.
Exclusion criteria: The patients who do not qualify for ES (cancer, electronic implants, malignant, tunnelling and necrotic wounds, osteomyelitis, PU requiring surgical intervention) will be excluded from participating, as well as those with diagnoses that might interfere with wound healing, such as diabetes (HbA1C > 7%), venous insufficiency, critical infection.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Skin - Other skin conditions

Neurological - Other neurological disorders

Physical Medicine / Rehabilitation - Physiotherapy

pressure ulcer;Wound healing;Chronic wound healing ;Central nervous system injury;
pressure ulcer
Wound healing
Chronic wound healing
Central nervous system injury

Intervention(s)

The purpose of this prospective, parallel-group, randomized, double-blind, controlled, clinical trial is to evaluate the activity of cytokines, growth factors and healing rates of pressure ulcers (PU) in people with central nervous system injures after 4 weeks of intervention involving standard wound care (SWC), SWC in conjunction with high voltage monophasic pulsed current (HVMPC) delivered by the cathode, and SWC combined with HVMPC 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 (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 Pressure Ulcer Advisory Panel criteria: Category II ulcers = partial-thickness loss of the dermis presenting as a shallow open ulcer with a red pink wound bed, without slough; Category III ulcers = full-thickness tissue loss; subcutaneous fat may be visible but bone, tendon or muscle are not exposed; Category 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

Primary Outcome(s)

Changes in the concentration of pro-inflammatory cytokines in peripheral blood (IL-1Beta, IL-6, TNF-alpha)[At baseline, week 2 and week 4]

Changes in the concentration of anti-inflammatory cytokines in peripheral blood (IL-10). [At baseline, week 2 and week 4]

Changes in the concentration of polypeptide growth factors in peripheral blood (FGF; IGF-1; VEGF, EGF, KGF, TGF beta1). [At baseline, week 2 and week 4]

Secondary Outcome(s)

Percentage change/decrease in WSA after 4 weeks of intervention with SWC + sham ES, SWC + cathode HVMPC, and SWC + anode HVPC (to compare changes in PU surface area between the groups).

Percentage WSA reduction from baseline at week 4 (PAR4) will be calculated with the following formula: PAR4 = initial WSA (cm2) – WSA (cm2) at week 4 x 100% / Initial WSA (cm2) [At baseline, and week 4]

Changes in gene expression for anti-inflammatory cytokines in the specimen of granulation tissue taken from wound edge.(IL-10)[At baseline, week 2 and week 4]

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).

[At baseline, and week 4]

Changes in gene expression for growth factors and their receptors in the specimen of granulation tissue taken from wound edge (FGF; IGF-1; VEGF, EGF, KGF, TGF beta1).

[At baseline, week 2 and week 4]

Changes in gene expression for pro-inflammatory cytokines in the specimen of granulation tissue taken from wound edge.(IL-1Beta, IL-6, TNF-alpha)[At baseline, week 2,, and week 4]

Secondary ID(s)

Nill known

Source(s) of Monetary Support

Academy of Physical Education

Ethics review

Status: Approved
Approval date:
Contact:

The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland

Results

• Results available: Yes
• Date Posted: 23/07/2019
• Date Completed: 27/02/2017