Efficacy of Phenytoin Phonophoresis on Pressure Ulcer Healing

NCT05542589 | Completed

• 1 other identifier: P.T.REC/012/003632
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of phenytoin phonophoresis on pressure ulcer healing

Conditions

Pressure Ulcer

Keywords

Phenytoin; phonophoresis; pressure ulcer

Outcome Measures

Primary Outcomes (1)

• 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 .

  Baseline and six weeks after the intervention

Study Arms (2)

Phenytoin phonophoresis group

EXPERIMENTAL

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.

Other: Phenytoin phonophoresis

sham phenytoin phonophoresis group

SHAM COMPARATOR

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.

Other: Sham phenytoin phonophoresis

Interventions

Phenytoin phonophoresis OTHER

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

Phenytoin phonophoresis group

Sham phenytoin phonophoresis OTHER

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

sham phenytoin phonophoresis group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shaimaa MA Elsayeh, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: March 1, 2022
• Primary Completion: February 14, 2023
• Study Completion: February 15, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)