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
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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