GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Osiris Therapeutics

Status and phase: Completed; Phase 4

Conditions: Foot Ulcer, Diabetic

Treatments: Other: GrafixPRIME®; Device: Off-loading (walking boot); Procedure: Dressing Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675855

Protocol 350

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

GrafixPRIME®

Experimental group

Description:

GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices

Treatment:

Other: GrafixPRIME®

Device: Off-loading (walking boot)

Active Comparator

Active Comparator group

Description:

Wound cover, Dressing Application Patients will be fitted with off-loading devices

Treatment:

Procedure: Dressing Application

Device: Off-loading (walking boot)