GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:4/6/2017
Start Date:January 2016
End Date:June 2017
Contact:Molly Saunders
Email:msaunders@osiris.com
Phone:443-545-1821

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A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration
to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.


Inclusion Criteria:

- Type 1 or Type 2 Diabetes

- Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks)

- Index ulcer located below the malleoli on the plantar or dorsal surface of the foot

- Index ulcer extends into the dermis or subcutaneous tissue without evidence of
exposed muscle, tendon, bone or joint capsule

- Adequate circulation to the foot (documented by ABI or TBI)

Exclusion Criteria:

- Gangrene present on affected foot

- Index ulcer is over a Charcot deformity

- Patient is receiving dialysis

- Patient has 2 or more previous amputations

- Patient has HbA1c >12% or random blood sugar >450 mg/dl

- Chronic oral steroid use

- Use of IV corticosteroid, immunosuppressive, or cytotoxic agents

- IV antibiotics

- Another ulcer within 5cm of the Index ulcer

- Cellulitis, evidence of infection, or osteomyelitis
We found this trial at
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