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Lymphomyosot for Ankle Edema Following Fracture
The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFebruary 22, 2012
February 1, 2012
2.8 years
April 19, 2009
February 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
3 weeks
Secondary Outcomes (4)
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
Study Arms (2)
Lymphomyosot
ACTIVE COMPARATORhomeopathic remedy
Placebo remedy
PLACEBO COMPARATORidentical in color, constituency and taste to true remedy
Interventions
Eligibility Criteria
You may qualify if:
- years of age and older
- patients with a fracture of the ankle requiring ORIF
- signed informed consent form.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Menachem Oberbaum, MD
Shaare Zedek Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Integrative Complementary Medicine
Study Record Dates
First Submitted
April 19, 2009
First Posted
April 21, 2009
Study Start
February 1, 2010
Primary Completion
December 1, 2012
Last Updated
February 22, 2012
Record last verified: 2012-02