High Voltage Pulsed Current Versus Microcurrent Stimulation Therapy in the Treatment of Chronic Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in wound surface area
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Closed envelop method
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Shaimaa Mohamed Ahmed Elsayeh
Lecturer of physical therapy
Cairo University