Pressure InjuriesNCT07493889
Electrical Stimulation for Clinical and Psychosocial Outcomes in Chronic Pressure Injuries
A study testing High-Voltage Monophasic Pulsed Current Electrical Stimulation and Standard Wound Care in people with Pressure Injuries and Spinal Cord Injuries (SCI), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injuries, Spinal Cord Injuries (SCI), Traumatic Brain Injury
- What is being tested?
- High-Voltage Monophasic Pulsed Current Electrical Stimulation and Standard Wound Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler physical therapy and rehabilitation hospital
Ankara
About this study
Official title: Healing Beyond the Wound: Clinical and Psychosocial Outcomes of Monophasic Electrical Stimulation in Pressure Injuries - A Randomized Controlled Pilot Study
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.
Read more
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.
- Being tested
- High-Voltage Monophasic Pulsed Current Electrical Stimulation, Standard Wound Care
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Voltage Monophasic Pulsed Current Electrical StimulationDevice
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 CareOther
Standard wound care includes routine wound cleaning, dressing changes, pressure off-loading strategies, and wound management according to institutional clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation + Standard Care | Experimental | Not described Receives: Device: High-Voltage Monophasic Pulsed Current Electrical Stimulation; Other: Standard Wound Care |
| Standard Wound Care | Active comparator | Not described Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Baseline and Week 6
Secondary outcomes (7)
Pain Intensity
Pain intensity associated with the pressure ulcer measured using the Visual Analog Scale (VAS).
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493889
- Sponsor's protocol ID
- HVMRPC-PI-RCT-2022
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Beyond the Wound: Clinical and Psychosocial Outcomes of Monophasic Electrical Stimulation in Pressure Injuries - A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07493889
- Acronym / sponsor ID
- HVMRPC-PI-RCT-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
Key exclusion criteria (5 listed)
- Presence of severe infection in the wound area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Voltage Monophasic Pulsed Current Electrical StimulationHigh-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. | Device | Electrical Stimulation + Standard Care |
| Standard Wound CareStandard wound care includes routine wound cleaning, dressing changes, pressure off-loading strategies, and wound management according to institutional clinical protocols. | Other | Electrical Stimulation + Standard Care, Standard Wound Care |
Primary outcome
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)
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.
7 secondary outcomes
Pain Intensity
Time frame: Baseline and Week 6
Change in Wound Diameter
Time frame: Baseline and Week 6
Depression Level (Hospital Anxiety and Depression Scale - Depression Subscale)
Time frame: Baseline and Week 6
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
Time frame: Baseline and Week 6
Wound Edema at Final Assessment
Time frame: 6 weeks
Wound Exudate Presence at Final Assessment
Time frame: 6 weeks
Wound Edge Integrity at Final Assessment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Voltage Monophasic Pulsed Current Electrical Stimulation and Standard Wound Care in people with Pressure Injuries and Spinal Cord Injuries (SCI), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure Ulcer Scale for Healing (PUSH) Score (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.