WoundNCT05601245
High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
A study testing High voltage pulsed current and Microcurrent therapy in people with Wound and Ulcer, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- What is being tested?
- High voltage pulsed current and Microcurrent therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2022to 20 Jul 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are of both sexes.
- Subject's age will be from 45 to 60 years.
- All patients will enter the study having their informed consent.
- All patients will be assessed by a physician before starting the study procedure.
- All patients suffer from a chronic wound not healed more than or within six weeks.
Who cannot join
- Patients with acute wounds.
- Patients with burn wound injuries.
- Malignancy in the wound.
- Necrotic tissue in the wound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds
The purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects.
Read the detailed description
Sixty patients with chronic wounds (pressure ulcers) and their ages will be ranged from 45 to 60 years old. They will be recruited from the outpatient clinic at Kasr Al-Aini Hospitals and they will be randomly assigned into two groups of equal numbers, each one will contain thirty patients. High-voltage pulsed current group and microcurrent stimulation therapy groups. The change in wound surface area and wound volume will be measured before the intervention and after six weeks of intervention.
- Being tested
- High voltage pulsed current, Microcurrent therapy
- Keywords
- High-voltage pulsed current, Micro-current therapy, Chronic wound
- Medical subject headings
- Wounds and Injuries, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High voltage pulsed currentOther
Also called Conventional physical therapy program
The treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes)
Microcurrent therapyOther
Also called Conventional physical therapy program
The treatment session duration is 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High voltage pulsed current | Experimental | Twenty patients with chronic wounds will be managed by the high-voltage pulsed current for 45 as the total treatment duration and the polarity will be reversed after 22 minutes, three sessions per week for six weeks. Receives: Other: High voltage pulsed current |
| Microcurrent therapy | Experimental | Twenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks. Receives: Other: Microcurrent therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound surface area
A sterilized transparency film will be placed over the ulcer. The ulcer perimeter was traced by using the film tipped transparency marker. Each ulcer was traced three times to establish measurement reliability. After tracing, the side of the transparency film facing the ulcer will be cleaned with a piece of cotton and alcohol. Carbon paper was placed over the 1-mm-squared metric graph paper. The traced transparency film was placed over the carbon paper with white paper in between and the tracing will be transcribed onto the metric graph paper. WSA was calculated by counting the number of square millimeters on the metric graph within the wound tracing. The mean value of the three trials was calculated and taken to be the wound surface area.
Measured: Baseline and six weeks after the intervention.
Change in wound volume
Assessment of wound volume was done by saline injection tool. A syringe of twenty cubic centimeters filled with normal sterilized saline was used. The patient was positioned in a comfortable position that allows the wound to be filled with the saline solution maximally. The saline was injected into each wound until its filling. The amount of saline injected was detected in cubic centimeters. These measurements were conducted for each patient before and after of treatment.
Measured: Baseline and six weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start10 Aug 2022
- Primary completion28 Apr 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Sixty patients (male and female) with chronic wounds (pressure ulcers) does not heal within six weeks were involved in the study. The diagnosis will be made clinically by the physician. The patients will be randomly assigned into two equal groups in number, two study groups (one for high-voltage pulsed galvanic current and the other for microcurrent therapy). Both groups will receive the same traditional physical therapy routine and conservative treatment for the wound for six weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA Elsayeh, PhD, Study director, Lecturer at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601245
- Sponsor's protocol ID
- P.T.REC/012/003742
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds
- ClinicalTrials.gov ID
- NCT05601245
- Acronym / sponsor ID
- P.T.REC/012/003742
- Keywords
- High-voltage pulsed current, Micro-current therapy, Chronic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 1 Nov 2022 (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.
The purpose of this study is to evaluate the effectiveness of high-voltage pulsed current (HVPC) and microcurrent stimulation therapy (MST) in treating chronic wounds and to compare their effects.
Detailed description
Sixty patients with chronic wounds (pressure ulcers) and their ages will be ranged from 45 to 60 years old. They will be recruited from the outpatient clinic at Kasr Al-Aini Hospitals and they will be randomly assigned into two groups of equal numbers, each one will contain thirty patients. High-voltage pulsed current group and microcurrent stimulation therapy groups. The change in wound surface area and wound volume will be measured before the intervention and after six weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty patients (male and female) with chronic wounds (pressure ulcers) does not heal within six weeks were involved in the study. The diagnosis will be made clinically by the physician. The patients will be randomly assigned into two equal groups in number, two study groups (one for high-voltage pulsed galvanic current and the other for microcurrent therapy). Both groups will receive the same traditional physical therapy routine and conservative treatment for the wound for six weeks.
| Arm | Type | Receives |
|---|---|---|
| High voltage pulsed current | Experimental | Other: High voltage pulsed currentTwenty patients with chronic wounds will be managed by the high-voltage pulsed current for 45 as the total treatment duration and the polarity will be reversed after 22 minutes, three sessions per week for six weeks. |
| Microcurrent therapy | Experimental | Other: Microcurrent therapyTwenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients are of both sexes.
- Subject's age will be from 45 to 60 years.
- All patients will enter the study having their informed consent.
- All patients will be assessed by a physician before starting the study procedure.
- All patients suffer from a chronic wound not healed more than or within six weeks.
Key exclusion criteria (4 listed)
- Patients with acute wounds.
- Patients with burn wound injuries.
- Malignancy in the wound.
- Necrotic tissue in the wound.
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 pulsed currentAlso: Conventional physical therapy programThe treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes) | Other | High voltage pulsed current |
| Microcurrent therapyAlso: Conventional physical therapy programThe treatment session duration is 40 minutes. | Other | Microcurrent therapy |
Primary outcome
Change in wound surface area
Time frame: Baseline and six weeks after the intervention.
A sterilized transparency film will be placed over the ulcer. The ulcer perimeter was traced by using the film tipped transparency marker. Each ulcer was traced three times to establish measurement reliability. After tracing, the side of the transparency film facing the ulcer will be cleaned with a piece of cotton and alcohol. Carbon paper was placed over the 1-mm-squared metric graph paper. The traced transparency film was placed over the carbon paper with white paper in between and the tracing will be transcribed onto the metric graph paper. WSA was calculated by counting the number of square millimeters on the metric graph within the wound tracing. The mean value of the three trials was calculated and taken to be the wound surface area.
Change in wound volume
Time frame: Baseline and six weeks after the intervention
Assessment of wound volume was done by saline injection tool. A syringe of twenty cubic centimeters filled with normal sterilized saline was used. The patient was positioned in a comfortable position that allows the wound to be filled with the saline solution maximally. The saline was injected into each wound until its filling. The amount of saline injected was detected in cubic centimeters. These measurements were conducted for each patient before and after of treatment.
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Shaimaa MA Elsayeh, PhD study director
Lecturer at Faculty of Physical Therapy, Cairo University
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 pulsed current and Microcurrent therapy in people with Wound and Ulcer, run by Cairo University at 1 site in Egypt.
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 4 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 20 Mar 2024. 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 Egypt. 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 wound surface area (time frame: Baseline and six weeks after the intervention.). 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 20 Mar 2024.