Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-02-15

Brief Summary

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Efficacy of phenytoin phonophoresis on pressure ulcer healing

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Detailed Description

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The purpose of the study is to evaluate the therapeutic effect of phenytoin phonophoresis on the healing of pressure ulcers.

Subjects: Forty patients suffering from pressure ulcers will be randomly divided into two equal groups each one has 20 patients, they will be selected from Al Kaser Al Aini. In this study, the patients will be randomly assigned into two equal groups (20 patients for each group) and will receive the treatment program three sessions per week for 6 weeks as a total period of treatment.

Phenytoin phonophoresis group (Study group): This group includes 20 patients with pressure ulcers who will receive topical phenytoin with ultrasound in addition to their conventional treatment.

Phenytoin phonophoresis group (Control group): This group will include 20 patients with pressure ulcers who will receive phenytoin with a placebo ultrasound.

Equipment and tools:

Measurement equipment: Saline injection method. Therapeutic equipment: Ultrasonic device, topical phenytoin, and hydrogel sheet.

Conditions

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Phenytoin phonophoresis group

The topical phenytoin will be applied on the head of ultrasound and is usually given for 5-10 minute sessions, three times per week and six weeks as a total treatment duration.

Group Type EXPERIMENTAL

Phenytoin phonophoresis

Intervention Type OTHER

Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

sham phenytoin phonophoresis group

The topical phenytoin will be applied on the head of ultrasound (sham ultrasound) and is usually given for 5-10 minute sessions, three times per week and six weeks as total treatment duration.

Group Type SHAM_COMPARATOR

Sham phenytoin phonophoresis

Intervention Type OTHER

Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Interventions

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Phenytoin phonophoresis

Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Intervention Type OTHER

Sham phenytoin phonophoresis

Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Ages range from 40 to 60 years, both genders, patients with pressure ulcers, and patients who will sign their informed consent.

Exclusion Criteria

Patients with a history of hypersensitivity to phenytoin, pneumonia, immune deficiency, infection, advanced diabetic patients, radiotherapy in the ulcer area, osteomyelitis in the ulcer area, venous ulcers, burn wounds, leprosy trophic ulcers, traumatic wounds, pregnant subjects, terminally ill subjects, and the use of antineoplastic agents or systemic glucocorticosteroids.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No