Phase
Condition
Tendon Injuries
Sprains
Treatment
N/AClinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ages 18 to 60 inclusive
If female, actively practicing a medically relevant method of contraception,abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
Have a diagnosis of one of the following in relation to the peroneal tendon:
Tendonitis with MRI confirmation
Synovial inflammation
Tear
Diagnosis resulting from acute injury to the tendon
Exclusion
Exclusion Criteria:
BMI equal to or greater than 35
Prior injury to the peroneal tendon
Collagen disorders
Inflammatory arteriopathies
Immune compromised
Diabetic
Less than 6 months between injury and proposed surgery date
Steroid injection within the past 6 weeks localized to the treatment area
Pregnant within the past six (6) months, breast feeding and/or desire to becomepregnant during the course of the study, as verified by urine pregnancy test withinone week prior to treatment
History of more than two (2) weeks treatment with immuno-suppressants, includingsystemic corticosteroids or cytotoxic chemotherapy within one month prior to initialscreening, or have received such medications during the screening period, or areanticipated to require such medications during the course of the study
Taking any investigational drug(s) or therapeutic device(s) within 30 days precedingscreening
History of radiation therapy of the affected foot
Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
Currently involved in medical litigation, including Worker's Compensation claims ofany type
Unable to understand the objectives of the trial
Presence of any condition(s) which, in the opinion of the investigator, wouldcompromise the subject's ability to complete this study
Having a known history of poor adherence with medical treatment
Express an unwillingness to receive human allograft tissue
Study Design
Study Description
Connect with a study center
Central Research Associates, Inc.
Birmingham, Alabama 35205
United StatesActive - Recruiting
University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
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