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Lymphomyosot for Ankle Edema Following Fracture

This study has suspended participant recruitment.
(Study recruiter withdrew from study. Suspended until replacement found.)
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00884988
First received: April 19, 2009
Last updated: February 19, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Ankle Injuries
Fracture
 Drug: Lymphomyosot
Drug: Placebo remedy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

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

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

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884988

Locations
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00884988     History of Changes
Other Study ID Numbers: LYM.ANKLE.09
Study First Received: April 19, 2009
Last Updated: February 19, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
ankle fracture
edema
surgical repair
homeopathy
lymphomyosot

Additional relevant MeSH terms:
Edema
Fractures, Bone
Ankle Injuries
 Signs and Symptoms
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on June 17, 2013