Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status

Completed

Conditions

Traumatic Brain Injury

Spinal Cord Injuries (SCI)

Pressure Injuries

Treatments

Other: Standard Wound Care

Device: High-Voltage Monophasic Pulsed Current Electrical Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07493889

HVMRPC-PI-RCT-2022

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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