Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers

NCT05285930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-18

No results posted yet for this study

Summary

PURPOSE: to determine the impact of bee venom phonophoresis in accelerating ulcers healing.

BACKGROUND: Bee venom (BV) phonophoresis has been suggested as a noninvasive treatment for a number of inflammatory conditions and in healing of ulcers.

Ulceration due to vascular causes is often multifactorial and can be caused by both arterial and venous disease. Hypertension and atherosclerosis of the peripheral vessels lead to arterial disease associated with ischemic ulcers. Chronic venous insufficiency and the resulting venous hypertension cause venous ulcers.

There are lack in knowledge and information in published studies about the efficacy of bee venom phonophoresis as physical therapy modality in accelerating ulcers healing.

So, this study will be designed to provide a guideline about the efficacy of of bee venom phonophoresis in accelerating ulcers healing.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that Bee venom phonophoresis has no or limited effect in accelerating ulcers healing.

RESEARCH QUESTION: Does Bee venom phonophoresis an effect in accelerating ulcers healing?

Conditions

  • Ulcer, Leg

Interventions

COMBINATION_PRODUCT

Bee venom phonophoresis

phonophoresis with Bee Venom gel in form of a noncontact low-frequency pulsed ultrasound delivered through Bee Venom gel as a topical treatment at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care. The performance of the ultrasound applicator was tested regularly before and after each patient exposure; each test included all relevant acoustic field parameters (pressure amplitude, frequency) and uniformity of the field distribution. This type of test of the acoustic output of the applicators was important to eliminate the possibility of any malfunctioning of the devices.

DEVICE

low intensity ultrasound

a noncontact low-frequency pulsed ultrasound delivered through plain gel only at a distance of between 5 and 15 mm from the ulcer wound bed, and time was 10 minutes for each session in addition to conservative treatment of medical ulcer care.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • eman othman, professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-01-20
Completion
2022-02-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285930 on ClinicalTrials.gov