Lymphomyosot for Ankle Edema Following Fracture

Shaare Zedek Medical Center

Status and phase

Suspended

Phase 2

Conditions

Fracture

Ankle Injuries

Treatments

Drug: Lymphomyosot

Drug: Placebo remedy

Study type

Interventional

Funder types

Other

Identifiers

NCT00884988

LYM.ANKLE.09

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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