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 |
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.
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
3
sites
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