Ankle InjuriesPhase 2NCT00884988
Lymphomyosot for Ankle Edema Following Fracture
A Phase 2 study testing Lymphomyosot in people with Ankle Injuries and Fracture, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries, Fracture
- What is being tested?
- Lymphomyosot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- patients with a fracture of the ankle requiring ORIF
- signed informed consent form.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ankle Injuries, Fracture
- Being tested
- Lymphomyosot, Placebo remedy
- Keywords
- ankle fracture, edema, surgical repair, homeopathy, lymphomyosot
- Medical subject headings
- Ankle Injuries, Fractures, Bone, Ankle Fractures, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphomyosotDrug
20 drops X3/day, until discharge
Placebo remedyDrug
20 drops X3/day, until discharge
| Study group | Role | What they receive |
|---|---|---|
| Lymphomyosot | Active comparator | homeopathic remedy Receives: Drug: Lymphomyosot |
| Placebo remedy | Placebo comparator | identical in color, constituency and taste to true remedy Receives: Drug: Placebo remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
Measured: 3 weeks
Secondary outcomes (4)
To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.
Measured: 3 weeks
To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.
Measured: 3 weeks
To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.
Measured: 3 weeks
To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2012 (estimated)
Why it stopped: Study recruiter withdrew from study. Suspended until replacement found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menachem Oberbaum, Shaare Zedek Medical Center
- Investigators
- Menachem Oberbaum, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884988
- Sponsor's protocol ID
- LYM.ANKLE.09
- Status last verified
- Feb 2012
- First submitted
- 19 Apr 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lymphomyosot in the Treatment of Posttraumatic Edema Following Ankle Fracture, Pending Surgery: a Randomized, Double-blind, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT00884988
- Acronym / sponsor ID
- LYM.ANKLE.09
- Conditions
- Ankle Injuries, Fracture
- Keywords
- ankle fracture, edema, surgical repair, homeopathy, lymphomyosot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study recruiter withdrew from study. Suspended until replacement found.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphomyosot | Active comparator | Drug: Lymphomyosothomeopathic remedy |
| Placebo remedy | Placebo comparator | Drug: Placebo remedyidentical in color, constituency and taste to true remedy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- patients with a fracture of the ankle requiring ORIF
- signed informed consent form.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphomyosot20 drops X3/day, until discharge | Drug | Lymphomyosot |
| Placebo remedy20 drops X3/day, until discharge | Drug | Placebo remedy |
Primary outcome
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
Time frame: 3 weeks
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lymphomyosot in people with Ankle Injuries and Fracture, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.