Lymphomyosot for Ankle Edema Following Fracture - Full Text View

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00884988

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Ankle Injuries and Disorders Deep Vein Thrombosis Edema Fractures Surgery

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:	40
Study Start Date:	June 2009
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lymphomyosot: Active Comparator homeopathic remedy	Drug: Lymphomyosot 20 drops X3/day, until discharge
Placebo remedy: Placebo Comparator 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

Contacts

Contact: Menachem Oberbaum, MD

972-2-6666395

oberbaum@szmc.org.il

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:	Shaare Zedek Medical Center, Jerusalem, Israel. ( Menachem Oberbaum, MD )
Study ID Numbers:	LYM.ANKLE.09
Study First Received:	April 19, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00884988 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:

ankle fracture
edema
surgical repair
homeopathy
lymphomyosot

Study placed in the following topic categories:

Ankle Injuries
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Edema
Leg Injuries

Additional relevant MeSH terms:

Ankle Injuries
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on August 24, 2009