High Voltage Pulsed Current and Microcurrent Stimulation Therapy in Treatment of Wounds.

Wound Clinical Trial

Official title:

High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601245
• Other study ID #: P.T.REC/012/003742
• Status: Completed
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ulcer
• Wound
• Wounds and Injuries

Intervention

Other:
• High voltage pulsed current
The treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes)
• Microcurrent therapy
The treatment session duration is 40 minutes.

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed Elsayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and six weeks after the intervention.
Primary	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.	Baseline and six weeks after the intervention