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Trial record 3 of 468 for:    shaare zedek

Lymphomyosot for Ankle Edema Following Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884988
Recruitment Status : Suspended (Study recruiter withdrew from study. Suspended until replacement found.)
First Posted : April 21, 2009
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Ankle Injuries Fracture Drug: Lymphomyosot Drug: Placebo remedy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
Study Start Date : February 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Lymphomyosot
homeopathic remedy
Drug: Lymphomyosot
20 drops X3/day, until discharge

Placebo Comparator: Placebo remedy
identical in color, constituency and taste to true remedy
Drug: Placebo remedy
20 drops X3/day, until discharge

Primary Outcome Measures :
  1. To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication. [ Time Frame: 3 weeks ]
  2. To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication. [ Time Frame: 3 weeks ]
  3. To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group. [ Time Frame: 3 weeks ]
  4. To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis). [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884988

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Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
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Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center Identifier: NCT00884988    
Other Study ID Numbers: LYM.ANKLE.09
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Menachem Oberbaum, Shaare Zedek Medical Center:
ankle fracture
surgical repair
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Ankle Injuries
Wounds and Injuries
Leg Injuries