Back to resultsHigh Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
Primary Purpose
Wound, Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High voltage pulsed current
Microcurrent therapy
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring High-voltage pulsed current, Micro-current therapy, Chronic wound
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients with acute wounds. Patients with burn wound injuries. Malignancy in the wound. Necrotic tissue in the wound.
Sites / Locations
- Shaimaa Mohamed Ahmed ElsayehRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High voltage pulsed current
Microcurrent therapy
Arm Description
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.
Twenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05601245
Brief Title
High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
Official Title
High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Ulcer
Keywords
High-voltage pulsed current, Micro-current therapy, Chronic wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Closed envelop method
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High voltage pulsed current
Arm Type
Experimental
Arm Description
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.
Arm Title
Microcurrent therapy
Arm Type
Experimental
Arm Description
Twenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks.
Intervention Type
Other
Intervention Name(s)
High voltage pulsed current
Other Intervention Name(s)
Conventional physical therapy program
Intervention Description
The treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes)
Intervention Type
Other
Intervention Name(s)
Microcurrent therapy
Other Intervention Name(s)
Conventional physical therapy program
Intervention Description
The treatment session duration is 40 minutes.
Primary Outcome Measure Information:
Title
Change in wound surface area
Description
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.
Time Frame
Baseline and six weeks after the intervention.
Title
Change in wound volume
Description
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.
Time Frame
Baseline and six weeks after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients with acute wounds.
Patients with burn wound injuries.
Malignancy in the wound.
Necrotic tissue in the wound.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa MA El Sayeh, PhD
Phone
+201007766160
Email
sh.sayeh87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Organizational Affiliation
Lecturer at Faculty of Physical Therapy, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed Elsayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Phone
01007766160
Email
shaimaa.elsayeh@cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Esraa T Mohamed, BSC
First Name & Middle Initial & Last Name & Degree
Nancy H Aboelnour, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.
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