GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Completed · Phase 4

Conditions studied: Foot Ulcer, Diabetic

In brief

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.

Key facts

Study ID

NCT02675855

Run by

Osiris Therapeutics

People needed

75

Starts

2016-01-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Arizona City, Arizona, United States
• Study site — California City, California, United States
• Study site — New Mexico, New Mexico, United States

Full record on ClinicalTrials.gov

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