Lymphomyosot for Ankle Edema Following Fracture
|ClinicalTrials.gov Identifier: NCT00884988|
Recruitment Status : Suspended (Study recruiter withdrew from study. Suspended until replacement found.)
First Posted : April 21, 2009
Last Update Posted : February 22, 2012
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 or disease||Intervention/treatment||Phase|
|Ankle Injuries Fracture||Drug: Lymphomyosot Drug: Placebo remedy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2010|
|Estimated Primary Completion Date :||December 2012|
Active Comparator: Lymphomyosot
20 drops X3/day, until discharge
Placebo Comparator: Placebo remedy
identical in color, constituency and taste to true remedy
Drug: Placebo remedy
20 drops X3/day, until discharge
- To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication. [ Time Frame: 3 weeks ]
- To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication. [ Time Frame: 3 weeks ]
- To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication. [ Time Frame: 3 weeks ]
- To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group. [ Time Frame: 3 weeks ]
- To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis). [ Time Frame: 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884988
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Menachem Oberbaum, MD||Shaare Zedek Medical Center|