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

NCT ID: NCT05601245

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-07-20

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.

Conditions

Wound; Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High voltage pulsed current

Intervention Type: OTHER

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

Microcurrent therapy

Twenty patients with chronic wounds will be managed by microcurrent therapy for 40 minutes, three sessions per week for six weeks.

Group Type: EXPERIMENTAL

Microcurrent therapy

Intervention Type: OTHER

The treatment session duration is 40 minutes.

Interventions

High voltage pulsed current

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

Intervention Type: OTHER

Microcurrent therapy

The treatment session duration is 40 minutes.

Intervention Type: OTHER

Other Intervention Names

Conventional physical therapy program; Conventional physical therapy program

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa MA Elsayeh, PhD

Role: STUDY_DIRECTOR

Lecturer at Faculty of Physical Therapy, Cairo University

Locations

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003742

Identifier Type: -

Identifier Source: org_study_id