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NCT06374563 Clinical Trial

Tackling Pressure Ulcer Via Bee Venom Phonophoresis

Pressure Ulcers Clinical Trial

— ulcer  

Official title:
Tackling Chronic Pressure Ulcer Via Bee Venom Phonophoresis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06374563
Other study ID # BUC-IACUC-221109-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date March 1, 2024

Study information
Verified date April 2024
Source Badr University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• Group 2: Phonophoresis of Bee Venom gel
group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per weeks

Locations
Country Name City State
Egypt Badr University in Cairo Cairo

Sponsors (1)
Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

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