Lymphomyosot for Ankle Edema Following Fracture

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00884988
• Other study ID #: LYM.ANKLE.09
• Status: Suspended
• Phase: Phase 2
• First received: April 19, 2009
• Last updated: February 19, 2012
• Start date: February 2010

Study information

• Verified date: February 2012
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Fracture
• Fractures, Bone

Intervention

Drug:
• Lymphomyosot
20 drops X3/day, until discharge
• Placebo remedy
20 drops X3/day, until discharge

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.		3 weeks	Yes
Secondary	To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.		3 weeks	Yes
Secondary	To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.		3 weeks	Yes
Secondary	To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.		3 weeks	Yes
Secondary	To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).		3 weeks	Yes