GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
Phase 4
Completed
- Conditions
- Foot Ulcer, Diabetic
- Registration Number
- NCT02675855
- Lead Sponsor
- Osiris Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Complete closure of index wound Up to Day 56
- Secondary Outcome Measures
Name Time Method Time to wound closure Up to Day 56 Proportion of patients that achieve a 50% reduction or greater in wound size Day 28 Number of product applications Up to Day 56 Number of Adverse Events Up to Day 56 Number of patients with worsening of wound by ≥50% increase in size Up to Day 56