Lymphomyosot for Ankle Edema Following Fracture | NCT00884988

Studies
Lymphomyosot for Ankle Edema Following Fracture

NCT00884988

Sponsor

Shaare Zedek Medical Center

Status

Suspended

Last Update Posted

Feb 22, 2012Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Ankle Injuries
Fracture

Interventions

Lymphomyosot
Placebo remedy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study recruiter withdrew from study. Suspended until replacement found.

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Apr 19, 2009

First Submission Date that Met QC Criteria

Apr 20, 2009

First Posted Date

Apr 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical CenterPrincipal Investigator

Lead Sponsor

Shaare Zedek Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lymphomyosot	Active Comparator	homeopathic remedy	Drug: Lymphomyosot
Placebo remedy	Placebo Comparator	identical in color, constituency and taste to true remedy	Drug: Placebo remedy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lymphomyosot	Drug	20 drops X3/day, until discharge	Lymphomyosot
Placebo remedy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Menachem Oberbaum, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center		Jerusalem		91031	Israel

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries
D050723	Fractures, Bone
D064386	Ankle Fractures
D004487	Edema

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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