Status:
SUSPENDED
Lymphomyosot for Ankle Edema Following Fracture
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Ankle Injuries
Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 18 years of age and older
- patients with a fracture of the ankle requiring ORIF
- signed informed consent form.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00884988
Start Date
February 1 2010
Last Update
February 22 2012
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031