Lymphomyosot for Ankle Edema Following Fracture

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.

Conditions
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Ankle Injuries, Fracture

Intervention / Treatment
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* Drug: Lymphomyosot
* Drug: Placebo remedy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older patients with a fracture of the ankle requiring ORIF signed informed consent form. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lymphomyosot<br>homeopathic remedy | Drug: Lymphomyosot<br>* 20 drops X3/day, until discharge<br>|
| Placebo Comparator: Placebo remedy<br>identical in color, constituency and taste to true remedy | Drug: Placebo remedy<br>* 20 drops X3/day, until discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication. |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle fracture, edema, surgical repair, homeopathy, lymphomyosot