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

Not Applicable

Completed

• Conditions: Ulcer; Wound

• Registration Number: NCT05601245
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-01
• Primary Completion: 2023-04-28
• Study Completion: 2023-07-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in wound surface area	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.
Change in wound volume	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.

Trial Locations

Locations (1)

Shaimaa Mohamed Ahmed Elsayeh; 🇪🇬 Cairo, New Cairo, Egypt