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

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.

Study Overview

• Status: Completed
• Conditions: Ulcer; Wound
• Intervention / Treatment: Other: High voltage pulsed current; Other: Microcurrent therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 02
      • Shaimaa Mohamed Ahmed Elsayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High voltage pulsed current; 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.	Other: High voltage pulsed current; The treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes); Other Names: Conventional physical therapy program
Experimental: Microcurrent therapy; Twenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks.	Other: Microcurrent therapy; The treatment session duration is 40 minutes.; Other Names: Conventional physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Shaimaa MA Elsayeh, PhD, Lecturer at faculty of physical therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic wound; High-voltage pulsed current; Micro-current therapy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: P.T.REC/012/003742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No