Lymphomyosot for Ankle Edema Following Fracture
Primary Purpose
Ankle Injuries, Fracture
Status
Suspended
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Lymphomyosot
Placebo remedy
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injuries focused on measuring ankle fracture, edema, surgical repair, homeopathy, lymphomyosot
Eligibility 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
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lymphomyosot
Placebo remedy
Arm Description
homeopathic remedy
identical in color, constituency and taste to true remedy
Outcomes
Primary Outcome Measures
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
Secondary Outcome Measures
To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.
To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.
To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.
To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).
Full Information
NCT ID
NCT00884988
First Posted
April 19, 2009
Last Updated
February 19, 2012
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00884988
Brief Title
Lymphomyosot for Ankle Edema Following Fracture
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Suspended
Why Stopped
Study recruiter withdrew from study. Suspended until replacement found.
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Fracture
Keywords
ankle fracture, edema, surgical repair, homeopathy, lymphomyosot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphomyosot
Arm Type
Active Comparator
Arm Description
homeopathic remedy
Arm Title
Placebo remedy
Arm Type
Placebo Comparator
Arm Description
identical in color, constituency and taste to true remedy
Intervention Type
Drug
Intervention Name(s)
Lymphomyosot
Intervention Description
20 drops X3/day, until discharge
Intervention Type
Drug
Intervention Name(s)
Placebo remedy
Intervention Description
20 drops X3/day, until discharge
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.
Time Frame
3 weeks
Title
To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.
Time Frame
3 weeks
Title
To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.
Time Frame
3 weeks
Title
To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menachem Oberbaum, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
12. IPD Sharing Statement
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Lymphomyosot for Ankle Edema Following Fracture
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