Back to resultsGrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
Primary Purpose
Foot Ulcer, Diabetic
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GrafixPRIME®
Dressing Application
Off-loading (walking boot)
Sponsored by
About this trial
This is an interventional treatment trial for Foot Ulcer, Diabetic focused on measuring Grafix
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GrafixPRIME®
Active Comparator
Arm Description
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
Wound cover, Dressing Application Patients will be fitted with off-loading devices
Outcomes
Primary Outcome Measures
Complete closure of index wound
Secondary Outcome Measures
Time to wound closure
Proportion of patients that achieve a 50% reduction or greater in wound size
Number of product applications
Number of Adverse Events
Number of patients with worsening of wound by ≥50% increase in size
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02675855
Brief Title
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
Official Title
A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osiris Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic
Keywords
Grafix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GrafixPRIME®
Arm Type
Experimental
Arm Description
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Wound cover, Dressing Application Patients will be fitted with off-loading devices
Intervention Type
Other
Intervention Name(s)
GrafixPRIME®
Intervention Description
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Intervention Type
Procedure
Intervention Name(s)
Dressing Application
Intervention Description
Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Intervention Type
Device
Intervention Name(s)
Off-loading (walking boot)
Intervention Description
Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
Primary Outcome Measure Information:
Title
Complete closure of index wound
Time Frame
Up to Day 56
Secondary Outcome Measure Information:
Title
Time to wound closure
Time Frame
Up to Day 56
Title
Proportion of patients that achieve a 50% reduction or greater in wound size
Time Frame
Day 28
Title
Number of product applications
Time Frame
Up to Day 56
Title
Number of Adverse Events
Time Frame
Up to Day 56
Title
Number of patients with worsening of wound by ≥50% increase in size
Time Frame
Up to Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharron McCulloch
Organizational Affiliation
Director, Clinical Affairs
Official's Role
Study Director
Facility Information:
City
Arizona
State/Province
Arizona
Country
United States
City
California City
State/Province
California
Country
United States
City
New Mexico
State/Province
New Mexico
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
We'll reach out to this number within 24 hrs