Fracture Clinical Trial
Official title:
The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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