Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix



Status:Active, not recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2012
End Date:November 2016

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A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy
(MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in
subjects with diabetes mellitus and without significantly compromised arterial circulation.

This study will be a multi-center, prospective, randomized single-blinded study evaluating
the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound
closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism
and changes in functional quality of life, each subject will complete the Cardiff Wound
Impact Schedule and the SF-36v2™ at three time points during the study i) at initial
screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization).
Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of
the treatment arms.

Inclusion Criteria:

- Type I or Type II diabetes

- A diabetic foot ulcer located on the foot or ankle at least one square centimeter

Exclusion Criteria:

- Suspected or confirmed signs/symptoms of wound infection

- Hypersensitivity to bovine collagen
We found this trial at
16
sites
920 Madison Ave
Memphis, Tennessee 38163
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Arecibo,
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Augusta, GA
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Carmel, Indiana 46032
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Carmel, IN
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Lake Charles, Louisiana 70601
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Lake Charles, LA
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Lake Success, NY
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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Lancaster, OH
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Los Angeles, California 90010
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Los Angeles, CA
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Miami, FL
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Mooresville, Indiana 46158
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Mooresville, IN
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North Kansas City, Missouri 64116
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North Kansas City, MO
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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St. Louis, Missouri 63128
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St. Louis, MO
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Tampa, Florida 33606
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Tampa, FL
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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