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Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

Primary Purpose

Pressure Ulcer

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phenytoin phonophoresis
Sham phenytoin phonophoresis
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring Phenytoin, phonophoresis, pressure ulcer

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaimaa Mohamed Ahmed Elsayeh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Phenytoin phonophoresis group

sham phenytoin phonophoresis group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in wound volume
by saline gel injection method Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount .

Secondary Outcome Measures

Full Information

First Posted
September 12, 2022
Last Updated
February 13, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05542589
Brief Title
Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing
Official Title
Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Anticipated)
Study Completion Date
February 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy of phenytoin phonophoresis on pressure ulcer healing
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Phenytoin, phonophoresis, pressure ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenytoin phonophoresis group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham phenytoin phonophoresis group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Phenytoin phonophoresis
Intervention Description
Phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.
Intervention Type
Other
Intervention Name(s)
Sham phenytoin phonophoresis
Intervention Description
Sham phenytoin phonophoresis for 5-10 minute sessions, three times per week and six weeks as a total period treatment.
Primary Outcome Measure Information:
Title
Change in wound volume
Description
by saline gel injection method Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount Amount of saline gel will be applied by steralized single use syringe in wound cavity then score this amount .
Time Frame
Baseline and six weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA Elsayeh, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed Elsayeh
City
Cairo
State/Province
New Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

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