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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation + Standard Care | Experimental |
| |
| Standard Wound Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity associated with the pressure ulcer measured using the Visual Analog Scale (VAS). | Baseline and Week 6 |
| Change in Wound Diameter | Description: Maximum wound diameter measured in centimeters using a disposable wound ruler at baseline and 6 weeks. Units: Centimeters (cm) |
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Inclusion Criteria:
Adults aged 18 years or older
Exclusion Criteria:
Presence of severe infection in the wound area
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Gaziler physical therapy and rehabilitation hospital | Ankara | Turkey (Türkiye) |
Individual participant data will not be shared, as this is a small-scale pilot randomized controlled trial with a limited sample size (n=20). Data are available from the corresponding author upon reasonable request
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|
| 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. |
|
| Baseline and Week 6 |
| Depression Level (Hospital Anxiety and Depression Scale - Depression Subscale) | 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 | Baseline and Week 6 |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score | 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) | Baseline and Week 6 |
| Wound Edema at Final Assessment | 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 weeks |
| Wound Exudate Presence at Final Assessment | Presence or absence of wound exudate assessed at 6 weeks, reported as percentage of participants with exudate present. Units: Percentage of participants (%) | 6 weeks |
| Wound Edge Integrity at Final Assessment | Presence or absence of wound edge integrity assessed at 6 weeks, reported as percentage of participants demonstrating intact wound edges. Units: Percentage of participants (%) | 6 weeks |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D013119 | Spinal Cord Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
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