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Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries

NCT07493889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

DEVICE

High-Voltage Monophasic Pulsed Current Electrical Stimulation

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.

OTHER

Standard Wound Care

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

Sponsors & Collaborators

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-09-01
Completion
2023-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493889 on ClinicalTrials.gov