GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

Phase 4

Completed

• Conditions: Foot Ulcer, Diabetic
• Interventions: Procedure: Dressing Application; Other: GrafixPRIME®; Device: Off-loading (walking boot)

• 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

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-17

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

Arm && Interventions

Group	Intervention	Description
Active Comparator	Dressing Application	Wound cover, Dressing Application Patients will be fitted with off-loading devices
Active Comparator	Off-loading (walking boot)	Wound cover, Dressing Application Patients will be fitted with off-loading devices
GrafixPRIME®	GrafixPRIME®	GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
GrafixPRIME®	Off-loading (walking boot)	GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices

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