Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers (NCT05285930) | Clinical Trial Compass
CompletedNot Applicable
Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers
Egypt45 participantsStarted 2021-08-01
Plain-language 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?
Who can participate
Age range
40 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible patients ranged in age from 40 to 60 years.
* They had not undertaken another physical therapy modality for ulcer healing
* non-smokers
* under their own prescribed medications, and controlled diet therapy as described by their physicians.
* All patients in the diabetic foot ulcer group (group B) were non-insulin dependent and had controlled blood glucose levels.
Exclusion Criteria:
* Patients with life-threatening disorders such as renal failure, myocardial infarction.
* any systemic diseases that may interfere with the study's objectives were excluded.
* patients with skin disease.
* any disease that can lead to ulcer rather than diabetes for the diabetic foot ulcer group only, as varicose veins, trauma, peripheral vascular diseases, and/or active malignancy.
* Ulcer with surface area of less than 2 cm2 or more than 8 cm2 would be excluded from the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used bee venom delivered through ultrasound — a technique called phonophoresis — to treat chronic leg ulcers. Could this approach be relevant to my specific type of leg ulcer, and is it something worth exploring given my current treatment plan?
2The trial measured ulcer surface area and volume as its main outcomes — can you help me understand whether my ulcer's size and depth would make those kinds of measurements a meaningful way to track my own progress, regardless of what treatment we choose?
3Since this trial is already completed, have the results been published anywhere, and if so, what did they show about whether bee venom phonophoresis actually helped wounds heal faster or close more completely?
4This study was listed as 'Phase NA,' which often means it was more of a preliminary or exploratory study — does that mean there's still limited evidence on safety and effectiveness, and should I be cautious about seeking out this treatment outside of a research setting?
5Before considering something like bee venom therapy, are there standard treatments for chronic leg ulcers that I haven't tried yet that might have stronger evidence behind them and could be a better starting point for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The ulcer surface area
Timeframe: changes from baseline, 6 weeks, 12 weeks of therapy.
2
ulcer volume measurement
Timeframe: changes from baseline, 6 weeks, 12 weeks of therapy.