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

NCT05601245 | Completed

• 1 other identifier: P.T.REC/012/003742
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Ulcer

Keywords

High-voltage pulsed current; Micro-current therapy; Chronic wound

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Other: Microcurrent therapy

Interventions

High voltage pulsed current OTHER

The treatment session duration is 45 minutes (Reverse the polarity after the first 22 minutes)

Also known as: Conventional physical therapy program

High voltage pulsed current

Microcurrent therapy OTHER

The treatment session duration is 40 minutes.

Also known as: Conventional physical therapy program

Microcurrent therapy

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with acute wounds.
• Patients with burn wound injuries.
• Malignancy in the wound.
• Necrotic tissue in the wound.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaimaa MA Elsayeh, PhD

  Lecturer at Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Closed envelop method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: November 1, 2022
• Study Start: August 10, 2022
• Primary Completion: April 28, 2023
• Study Completion: July 20, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)