Veterinary Community

Clinical Studies & Research

Clinical Studies & Research at Friendship Hospital for Animals

FEBRUARY 9TH, 2018 – A FUNDED CLINICAL TRIAL TO EVALUATE A NOVEL PAIN MANAGEMENT THERAPY IN DOGS WITH OSTEOARTHRITIS

Trial Specifics:

This trial is designed to evaluate the tolerability, safety and effectiveness of a novel pain management therapy in dogs with osteoarthritis. The drug is administered as one-time intra-articular injections in 1 or 2 joints. The injection will be administered under sedation or general anesthesia. There is no placebo in this trial. An estimated 15 client-owned dogs with osteoarthritis will be enrolled at 2 different locations in the U.S. Owners will be required to complete pain assessment surveys, track their dog’s activity through the use of an activity monitor worn on the dogs collar, and record short at-home videos assessing the dog’s gait. The trial site will train the owners on all of these assessments. Trial visits include the dog’s initial consultation, treatment day (Day 0), and then recheck visits on Days 14, 28, 56, and 84. Medications targeted at the treatment of osteoarthritis associated pain are acceptable provided they have been administered for at least 2 weeks prior to enrolling in the study.

Trial Funding:

The trial is fully funded for the full trial duration (84 days). Funding includes the initial consultation, the study treatment and administration, radiographs prior to treatment (if not performed within 4 months of enrollment), recheck visits, required bloodwork, and management of side effects that are thought to be directly related to the trial.

Trial Eligibility:

Trained veterinarians at the trial sites will evaluate each dog for eligibility.

Dogs are eligible if they meet the following inclusion criteria:

  • Dog’s body weight 10-50 kg
  • Dog has clinical signs and radiographic evidence of osteoarthritis in one or multiple joints
  • Dog is experiencing osteoarthritis pain that is refractory to standard pain management or owner opts for pain management that is distinct from conventional treatments

Dogs are not eligible if they meet any of the following exclusion criteria:

  • Dog has a life expectancy of < 3 months
  • Dog has any underlying disease that will affect the study objectives or patient safety
  • Dog has concurrent or prior immune-mediated or other disease resulting polyarthropathy
  • Dog is impaired due to neurological disease or other orthopedic disease
  • Dog is pregnant or lactating
  • Dog is participating in another study
  • Dog may be unavailable for the entire trial duration or is felt to be unsuitable by the investigator for any other reason
  • Dog requires medications or supplements during the course of the study that interfere with the objectives of the study

Please contact Dr. Nicole Luensman or Dr. Mathieu Glassman to discuss enrolling your patient in this study.

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JANUARY 9TH, 2018 – A Funded Clinical Trial to Investigate the Cardiovascular Effects of Oral Steroid Use in Cats.

The Friendship Cardiology Specialists are seeking cats for a prospective observational research study investigating the cardiovascular effects of oral steroid use.
 
Trial Specifics:

Oral and parenteral steroids have been associated with increased plasma volume and development of congestive heart failure in cats without prior signs of heart disease, but criteria to identify cats at increased risk for steroid induced heart failure are not established. NT-pro BNP increases with myocardial stretch, but changes in NT-pro BNP with steroid therapy have not yet been investigated in cats. The primary objective of this study is to determine if oral steroid therapy in cats results in increased NT-pro BNP. The secondary objective of this study is to determine if any baseline patient characteristics help identify cats at risk for greater magnitude of BNP increase with steroid treatment

Trial Funding:

  • Cardiology consultation and recheck visit
  • Echocardiogram (initial and recheck)
  • PCV/TS/glucose/NT-pro BNP (initial and recheck)
  • Non-invasive blood pressure (initial and recheck)

Trial Eligibility:

  • Feline patient age ≥ 5 years
  • You plan to initiate at least a 5-7 day course of oral steroids at a consistent dose
  • You plan to continue the same diet for at least 5-7 days
  • CREA <1.7 within past 6 months**
  • Total T4 ≤ 4.0 within past 6 months (or controlled hyperthyroid on meds)**
  • Systolic blood pressure ≤ 160 (or controlled hypertensive on meds)
  • PCV ≥ 25

**Study will cover cost if not performed within past 6 months
Cats receiving diuretics, ACEi, or parenteral fluids may not be included
Cats treated with steroids in the past 2 weeks may not be included
Owners must commit to a recheck visit in 5-7 days.

Please contact Friendship Cardiology Specialists to discuss enrolling your patient in this study.

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OCTOBER 27TH, 2017 – Friendship Surgical Specialists (FSS) Research and Other Academic Projects.

Projects in Process (ongoing case collection or in-process for publication):

  • Incidence of Infections Associated with Wound-Soaker Catheters

Wound-soaker catheters are used to help reduce discomfort after surgery. These catheters are placed into a wound prior to wound closure and a constant amount of a local anesthetic infused into the wound helps to provide a pain-free recovery. While the excellent pain relieve with the use of these catheters has been described, and while we do not believe that there is an increased risk of infection associated with their use, this study is being conducted in an effort to confirm this hypothesis. Friendship Surgical Specialists once more works in cooperation with Texas A&M University on this project.

Currently enrolling cases. 

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  • Percutaneous versus Closed Proximal Tibial Tuberosity Fracture Treatment

A multi-institutional prospective study comparing the traditional surgical method to treat tibial tuberosity avulsion fractures using a pin-and-tension band and a study, published through Friendship Hospital for Animals in 2017, using a minimally invasive, percutaneous method to treat such fractures. Percutaneous means placement of implants directly through the skin, without making a long skin incision. Such technique follows the principles of minimally invasive orthopedics and biologic fracture repair, which have shown significant advantages in regards to healing times, infections, return to function and hospitalization times.

Currently enrolling cases.

  • Prospective Percutaneous Proximal Tibial Tuberosity Fracture Treatment

Prospective collection of case with tibial tuberosity avulsion fractures. This is the continuation of a study, published through Friendship Hospital for Animals in 2017, using a minimally invasive, percutaneous method to treat such fractures. Percutaneous means placement of implants directly through the skin, without making a long skin incision. Such technique follows the principles of minimally invasive orthopedics and biologic fracture repair, which have shown significant advantages in regards to healing times, infections, return to function and hospitalization times.

Currently enrolling cases.

  • Percutaneous Metabone Fracture Repair: a Prospective Study

Animals can break their feet just like humans can. This study focuses on the use of a percutaneous technique (placement of implants directly through the skin, without making a long skin incision) to treat the metacarpal and metatarsal bones in dogs and cats.

Currently enrolling cases.

  • Minimally Invasive Gastropexy

Gastric dilatation volvulus (GDV) is a condition when a dog’s stomach fills with air and twists around its own axis, resulting in cessation of blood flow and – if not treated – becoming a life-threatening condition. To avoid this problem, a preventative gastropexy can be performed early on in life: the stomach is sutured to the body wall, which avoids the development of GDV. Friendship Hospital for Animals has used a minimally invasive method to conduct this surgery for multiple years and is currently evaluating its long-term outcome. Based on currently available data, this minimally invasive method has consistently avoided GDV later in life and thus is recommended to be applied, for example at the time of spay/neuter etc., early in life.

Case enrollment completed. However, the technique is continuously applied at our hospital.

  • Survey of Veterinary Orthopedic Society Members on the Preferred Method to Treat Cranial Cruciate Ligament Rupture in Dogs Weighing More than 15kg.

Cranial cruciate ligament rupture (CCLR) with subsequent joint instability is the most common pathological condition affecting the canine stifle joint. While surgical stabilization is recommended, the surgical method with best long-term outcome is disputed. This survey among members of the Veterinary Orthopedic Society (an international organization consisting mainly of surgeons dedicated to orthopedic surgery) was undertaken in cooperation with Michigan State University and Tufts University.

Case enrollment completed. Publication in process.

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AUGUST 9TH, 2017 – Subclinical Bacteriuria in Dogs with CKD

Friendship Internal Medicine is now recruiting patients for a fully funded clinical study of Subclinical Bacteriuria in Dogs with CKD.

How do you approach a positive urine culture in a dog without any clinical signs?
Veterinary infectious disease experts have recommended that these dogs do not require therapy. However, diseases like chronic kidney disease (CKD) may increase the risk of ascending urinary tract infection. Currently, data isn’t available to help guide treatment recommendations. Our goal is to change that.  We are looking to enroll dogs with CKD and a positive urine culture, who lack clinical signs of lower or upper urinary tract infection.

This study is fully funded. All dogs will receive the following at no cost to the owners:

  • Exam by internal medicine specialist
  • Recheck urine culture to confirm bacteriuria
  • Complete blood count
  • Biochemical panel
  • Urinalysis
  • Urine protein:creatinine ratio
  • Urinary tract ultrasound
  • Analysis of serum and urinary renal injury biomarkers
Dogs will not receive antibiotic therapy throughout the duration of the study unless clinical signs of infection develop. Dogs with clinical signs of urinary tract infection at the time of enrollment will be treated with appropriate antimicrobials and not be eligible for enrollment.  All dogs will receive complimentary recheck examinations and free labwork at 1, 3, and 6 months after enrollment. 
 
Please contact Friendship Internal Medicine to discuss enrolling your patient in this study.
 
 

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