The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
研究概览
简要总结
Ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout Europe and the U.S., primarily for tissue edema and swelling.
This is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment. The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require ORIF repair will be assessed for inclusion in this study.
The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •patients with a fracture of the ankle requiring ORIF
- •signed informed consent form.
排除标准
- •refusal or inability to give informed consent
- •bilateral fractures of the foot or ankle, open fractures, poly-trauma, contralateral limb amputation
- •currently on anticoagulation therapy
- •clinical indication for immediate surgery.
- •ability to undergo surgery on the day of the fracture , or where soft-tissue edema was not the cause which prevented immediate surgery
- •any additional injury that prevents partial weight-bearing.
- •a concomitant fracture of another long bone in the ipsilateral leg
- •if the patient suffers from a systemic disease such as diabetes, malignant tumor, severe peripheral vasculopathy, and/or metabolic disease
- •concurrent participation in another study
- •inability to comply with the study protocol
研究组 & 干预措施
Lymphomyosot
homeopathic remedy
干预措施: Lymphomyosot (Drug)
Placebo remedy
identical in color, constituency and taste to true remedy
干预措施: Placebo remedy (Drug)
结局指标
主要结局
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
时间窗: 3 weeks
次要结局
- To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.(3 weeks)
- To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.(3 weeks)
- To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.(3 weeks)
- To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).(3 weeks)
研究者
Menachem Oberbaum
Director, Center for Integrative Complementary Medicine
Shaare Zedek Medical Center