Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries

NCT07493889 | Completed

• 1 other identifier: HVMRPC-PI-RCT-2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Injuries; Spinal Cord Injuries (SCI); Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Change in Pressure Ulcer Scale for Healing (PUSH) Score

  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)

  Baseline and Week 6

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

  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.

  Baseline and Week 6

Secondary Outcomes (7)

• Pain Intensity

  Baseline and Week 6

• Change in Wound Diameter

  Baseline and Week 6

• Depression Level (Hospital Anxiety and Depression Scale - Depression Subscale)

  Baseline and Week 6

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

  Baseline and Week 6

• Wound Edema at Final Assessment

  6 weeks

Study Arms (2)

Electrical Stimulation + Standard Care

EXPERIMENTAL

Device: High-Voltage Monophasic Pulsed Current Electrical Stimulation; Other: Standard Wound Care

Standard Wound Care

ACTIVE COMPARATOR

Other: Standard Wound Care

Interventions

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.

Electrical Stimulation + Standard 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.

Electrical Stimulation + Standard Care; Standard Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Gaziler physical therapy and rehabilitation hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Brain Diseases; Craniocerebral Trauma

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)