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Navicular Edema Drug Trial Letter
2 . 1 . 2008


November 20, 2007

 

Dear Colleague,

 

Virginia Equine Imaging is participating in a clinical trial study for FDA approval of a drug for the treatment of navicular edema in the horse. This is a blind study sponsored by the manufacturer. There are nine veterinary centers in the nation participating. We are the only one in the Mid-Atlantic.

 

The basis of the study is to test the effectiveness of the drug in the treatment of navicular syndrome in the horse, characterized specifically by bony edema in the navicular bone itself with minimal soft tissue changes in the foot. The study will also compare the effectiveness of the drug and corrective shoeing combined versus corrective shoeing alone.

 

How does your client’s horse qualify?

Must be four years old or older.

Weight 551-1874 lbs.

Lameness grade of between 2/5 and 3/5, with the lamest leg on the inside of the circle. That lameness must be abolished with a palmar digital nerve block (PDN).

Radiographs of the foot without obvious coffin bone, coffin or pastern joint abnormalities, or erosion of the flexor cortex of the navicular bone.

 

Exclusion criteria:

Has received test article (tiludronate) in the past.

Clinically significant bloodwork abnormalities.

Pregnant or lactating mares.

Systemic disease.

Severe lameness criteria (severe flexions on any limb, multi-limb lameness behind, etc.) 

 

How Can Your Client’s Horse Enter the Study?

If you have a horse that fits the above inclusion criteria up to and including the point of blocking (+/- radiographs performed), and it has been receiving any of the following medications, it can go through the necessary drug withdrawal period prior to being referred to Virginia Equine Imaging. Allowing for the drug withdrawal period to occur saves the client time and redundancy prior to coming into VEI, as the lameness exam will have to be repeated (after the withdrawal period) at VEI. Drug withdrawal includes stopping the administration of NSAIDS or antibiotics in the 7 days preceding the lameness workup; Glucosamine, Chondroitin Sulphate, HA preparations or any feed supplements containing these substances, short acting corticosteroids or Isoxsuprine in the 14 days preceding the lameness workup; and long acting corticosteroids (Depo-Medrol) in the 30 days preceding the lameness workup.  Additionally, if vaccinations are not current they should be given prior to the drug withdrawal period (7 day withdraw).  Please have your client bring a copy of vaccination status including dates and manufacturer as well as a copy of a current coggins to VEI.

 

Once referred to Virginia Equine Imaging, should the horse still meet the qualifying criteria noted above, i.e. it moves and blocks the same way, it can enter the next phase of inclusion criteria which would involve radiographs if not already performed, and finally MRI evaluation. If the MRI diagnosis is navicular edema without significant soft tissue involvement, then the horse can officially enter the study, receiving either the placebo or test article (blinded), corrective shoeing by Scott Brouse, an exercise protocol, and periodic rechecks at VEI over the following 8 weeks (to be performed at two, four and eight weeks). At eight weeks it is revealed whether the horse received the drug or the placebo. If the horse received the placebo, it can then receive the drug and go into an open study. All of the horses in the open study will be evaluated on a bi-monthly basis. The owner must be willing to return for all of the scheduled visits.

 

Summary:

If the horse qualifies through all phases of the study it will mean a significant savings for your client (approximately $4000.00 of diagnostic imaging ) and a $250.00 referral fee for the referring vet if the blocks and radiographs are all able to be duplicated at VEI. This clinical trial will hopefully speed FDA approval of this very useful drug to the profession.

 

If you have any questions please feel free to call or email Dr. Laurie Tyrrell at the clinic, (540) 687-4663 or ltyrrell@vaequine.com 

 

In other news, Virginia Equine Imaging completed a successful makeover in its 11th year as
one of the most successful focused lameness and diagnostic equine centers in the United States. We completed several new expansion projects, a covered rolled stone dust lunge area, a soft sand surfaced lunge area and a tarmac jog strip. We have expanded our exam rooms and installed stocks for safer trans-rectal pelvic ultrasound and ultrasound-guided injections. We continue to accurately answer more drug and medication questions than any other private practice in the U.S

 

Our busy nuclear medicine department also underwent a significant High Definition upgrade this fall with a complete set of new tubes, new crystal imaging surface, and a new version of Mirage, the nuclear medicine software. These upgrades ensure that VEI offers the most advanced resolution, speed, and accuracy that is clinically available in nuclear imaging today.

 

We have continued to upgrade our imaging infrastructure with a terabyte image server that collects all of the images in the practice (in and out of clinic) and uploads them nightly to a secure server in California. We continue to invest in the most advanced Eklin digital radiology technology available and have been pleased with the results. Our Via software now interfaces with our image server providing images and history in real time at all workstations within our center. We are happy to provide in-clinic and out-clinic digital imaging for our referring DVM’s.

 

Exciting treatments coming in the near future include platelet rich plasma (PRP) injections for tendons and ligaments and bone marrow derived stem cell injections. IRAP injections continue to be used commonly in the practice for both soft tissue and joint issues and we are happy to process these for referring DVM’s.

 

We continue to invest in our people and education with all of our veterinarians on track for diplomate status in the International Society for Equine Locomotor Pathology (ISELP.org). This program directly relates to our daily activities of lameness and diagnostic imaging and certainly is the best program in the world for improving musculo-skeletal ultrasound skills.

 

Our mission of providing the equine athlete with unsurpassed excellence in sports medicine and diagnostic imaging continues unabated into our second decade. Please feel free to stop by and see any of our facilities or to discuss ways we can further support you and your practice.

 

 

Sincerely, 

 

A. Kent Allen, DVM

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