Effect of Bee Venom Phonophoresis on Healing of Chronic Lower Limb Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The ulcer surface area
研究概览
简要总结
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?
详细描述
• A verbal explanation about the importance of this research procedure, main aims and conceptual approaches were explained to every participant. • Every participant was given his written informed consent for bee venom phonophoresis treatment • The procedures of this study were divided into two main parts: part one (measurement procedures) and part two (treatment procedures).
Bee venom allergy test: The participants had been tested for BV allergy; diluted BV, 0.05 ml, in normal saline (1 mg/ml) was injected intra-dermally into the forearm. If the tested lesion resulted in a wheal with a diameter of less than 10 mm and erythema with a diameter of less than 26.5 mm after 10 to 15 minutes, subjects were participated in this study.
- Measurement procedure:
A- Ulcer surface area Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker. A separate transparency was used for each Ulcer. The tracing is then placed over metric graph paper and the number of 1mm the tracing was counted (only full 1 millimeter squares inside the perimeter is counted and the area was converted to square centimeters).
Ulcer area was measured before the beginning of the study and at the end of the first and second months of therapy and this process was repeated a minimum of three times for each measurement with the value obtained two or more times was reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The ulcer surface area
时间窗: changes from baseline, 6 weeks, 12 weeks of therapy.
The ulcer surface area would be estimated by placing a piece of sterilized transparency film over the ulcer and using a fine-tipped transparency marker to trace the ulcer perimeter on the film. Each ulcer was treated with its own transparency. The trace was then placed on metric graph paper, and the count of 1mm squares within the perimeter was counted (only entire 1mm squares were counted, and the area was converted to square centimeters)
ulcer volume measurement
时间窗: changes from baseline, 6 weeks, 12 weeks of therapy.
The patient would be in a comfortable position, with the ulcer facing upward. To have the longest length and width, the ulcer would be traced on translucent paper and placed over the metric graph paper. A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth. The volume of the ulcer would be calculated to have the width x length x depth ratio
次要结局
未报告次要终点
研究者
Eman Mohamed othman
professor
Cairo University