Tackling Pressure Ulcer Via Bee Venom Phonophoresis (ulcer)

April 16, 2024 updated by: Reham Alaa, Badr University

Tackling Chronic Pressure Ulcer Via Bee Venom Phonophoresis

This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the Bee Venom gel was prepared in a gel formula. Patients with chronic pressure ulcers were enrolled randomly into two different groups. Group 1 received a topical application of Bee Venom gel, 3 times per weeks. While group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per week. The treatment lasted for 8 consecutive weeks. The Image J Software is used to measure the wound surface area before and after treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11837
        • Badr University in Cairo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients with stage II and III chronic neuropathic ulcers.

Exclusion Criteria:

  • Patients with chronic cardiac,
  • Patients with renal, and
  • Patients with hepatic diseases and
  • Diabetic patients. Additionally,
  • Patients with immunosuppressive diseases,
  • Patients with HIV, and
  • Anemia Patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Group 1 received topical application of Bee Venom gel, 3 times per week
Other: group 1 received topical Bee venom gel
Group 1 received a topical application of Bee Venom gel, 3 times per weeks. The wound dressing changed day after day and was cleaned every time with normal saline.
Experimental: group 2
Group 1 received phonophoresis of Bee Venom gel using low intensity ultrasound, 3 times per week
Other: Group 2: Phonophoresis of Bee Venom gel
group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound surface area wound surface area
Time Frame: Before starting treatment and after 8 weeks of treatment
ImageJ Software was used to measure the wound size
Before starting treatment and after 8 weeks of treatment
wound volume
Time Frame: Before starting treatment and after 8 weeks of treatment
wound volume was measured through the volumetric measurement method using a syringe filled with saline
Before starting treatment and after 8 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Investigators

  • Study Director: Ashraf Hassan, professor, Badr University in Cairo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-IACUC-221109-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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