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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

The ulcer surface area

Timeframe: changes from baseline, 6 weeks, 12 weeks of therapy.

ulcer volume measurement

Timeframe: changes from baseline, 6 weeks, 12 weeks of therapy.

Trial details

NCT IDNCT05285930

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-20

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