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Completed

NCT Number: NCT05601245

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

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Key information

Conditions

Wound Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer Wounds and Injuries

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High voltage pulsed current

Other

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

Other names: Conventional physical therapy program

microcurrent therapy

Other

The treatment session duration is 40 minutes.

Other names: Conventional physical therapy program

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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