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NCT Number: NCT07493889

Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries

Pressure injuries are chronic wounds that frequently occur in immobilized patients and are associated with delayed healing, reduced quality of life, and significant psychological burden. Electrical stimulation has been suggested as an adjunctive therapy to promote wound healing by enhancing angiogenesis, improving cell migration, and restoring local bioelectric fields.

This randomized controlled pilot study aims to evaluate the clinical and psychosocial effects of high-voltage monophasic rectangular pulsed current (HVMRPC) in patients with chronic pressure injuries. Twenty adult patients with stage II-IV pressure injuries that did not respond to at least four weeks of standard wound care are randomly assigned to receive either HVMRPC in addition to standard wound care or standard wound care alone.

The intervention consists of electrical stimulation applied to the periwound area five times per week for six weeks. Clinical outcomes include changes in wound size and wound severity measured with the Pressure Ulcer Scale for Healing (PUSH). Psychosocial outcomes include anxiety and depression levels measured with the Hospital Anxiety and Depression Scale (HADS) and health-related quality of life measured with EQ-5D-5L.

The study investigates whether electrical stimulation provides additional benefits beyond standard wound care in improving both wound healing parameters and psychological well-being in patients with chronic pressure injuries.

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Key information

Conditions

Pressure Injuries Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries (SCI) Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Gaziler physical therapy and rehabilitation hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Presence of a pressure ulcer
  • Individuals receiving treatment and follow-up in the rehabilitation clinic
  • Ability to understand and comply with study procedures
  • Provision of written informed consent

Exclusion criteria

  • Presence of severe infection in the wound area
  • Malignant wound or suspected malignancy in the ulcer area
  • Presence of cardiac pacemaker or implanted electrical device
  • Severe cognitive impairment preventing cooperation
  • Participation in another clinical trial during the study period

Treatment and study plan

High-Voltage Monophasic Pulsed Current Electrical Stimulation

Device

High-voltage monophasic pulsed current electrical stimulation is applied to the periwound area using surface electrodes. The stimulation is delivered with a frequency of 120 Hz and a pulse duration of 150 microseconds. Each session lasts approximately 50 minutes and is administered five times per week for six weeks in addition to standard wound care.

Standard Wound Care

Other

Standard wound care includes routine wound cleaning, dressing changes, pressure off-loading strategies, and wound management according to institutional clinical protocols.

Primary outcomes

  1. Change in Pressure Ulcer Scale for Healing (PUSH) Score

    Time frame: Baseline and Week 6

    The PUSH tool assesses pressure injury status across three subscales: wound surface area (0-10), exudate amount (0-3), and tissue type (0-4). Total score ranges from 0 to 17; higher scores indicate greater wound severity. Score on a scale (0-17; higher score = worse outcome)

  2. Change in Hospital Anxiety and Depression Scale (HADS) total score

    Time frame: Baseline and Week 6

    The HADS is a 14-item self-report questionnaire with two subscales: anxiety (7 items, 0-21) and depression (7 items, 0-21). Total score ranges from 0 to 42; higher scores indicate greater psychological distress.

Secondary outcomes

  1. Pain Intensity

    Time frame: Baseline and Week 6

    Pain intensity associated with the pressure ulcer measured using the Visual Analog Scale (VAS).

  2. Change in Wound Diameter

    Time frame: Baseline and Week 6

    Description: Maximum wound diameter measured in centimeters using a disposable wound ruler at baseline and 6 weeks.

    Units: Centimeters (cm)

  3. Depression Level (Hospital Anxiety and Depression Scale - Depression Subscale)

    Time frame: Baseline and Week 6

    Assessment of depressive symptoms using the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D). The HADS-D consists of 7 items scored on a 4-point Likert scale (0-3); subscale scores range from 0 to 21, with higher scores indicating more severe depressive symptoms

  4. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score

    Time frame: Baseline and Week 6

    The EQ-5D-5L VAS measures self-rated overall health on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health). Assessed at baseline and Week 6.

    Time Frame: Baseline and Week 6 Units: Score on a scale (0-100; higher score = better outcome)

  5. Wound Edema at Final Assessment

    Time frame: 6 weeks

    Presence or absence of wound edema assessed by blinded outcome assessor at 6 weeks, reported as percentage of participants with edema present.

    Units: Percentage of participants (%)

  6. Wound Exudate Presence at Final Assessment

    Time frame: 6 weeks

    Presence or absence of wound exudate assessed at 6 weeks, reported as percentage of participants with exudate present.

    Units: Percentage of participants (%)

  7. Wound Edge Integrity at Final Assessment

    Time frame: 6 weeks

    Presence or absence of wound edge integrity assessed at 6 weeks, reported as percentage of participants demonstrating intact wound edges.

    Units: Percentage of participants (%)

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Healing Beyond the Wound: Clinical and Psychosocial Outcomes of Monophasic Electrical Stimulation in Pressure Injuries - A Randomized Controlled Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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