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Trial record 3 of 459 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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE April 19, 2009
First Posted Date  ICMJE April 21, 2009
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication. [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
  • To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication. [ Time Frame: 3 weeks ]
  • To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication. [ Time Frame: 3 weeks ]
  • To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group. [ Time Frame: 3 weeks ]
  • To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis). [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphomyosot for Ankle Edema Following Fracture
Official Title  ICMJE The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ankle Injuries
  • Fracture
Intervention  ICMJE
  • Drug: Lymphomyosot
    20 drops X3/day, until discharge
  • Drug: Placebo remedy
    20 drops X3/day, until discharge
Study Arms  ICMJE
  • Active Comparator: Lymphomyosot
    homeopathic remedy
    Intervention: Drug: Lymphomyosot
  • Placebo Comparator: Placebo remedy
    identical in color, constituency and taste to true remedy
    Intervention: Drug: Placebo remedy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
60
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2009)
40
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00884988
Other Study ID Numbers  ICMJE LYM.ANKLE.09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menachem Oberbaum, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP