GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

July 12, 2017 updated by: Osiris Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Arizona, Arizona, United States
    • California
      • California City, California, United States
    • New Mexico
      • New Mexico, New Mexico, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GrafixPRIME®
GrafixPRIME® is cryopreserved human placental membrane Patients will be fitted with off-loading devices
Other: GrafixPRIME®
Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
Device: Off-loading (walking boot)
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
Active Comparator: Active Comparator
Wound cover, Dressing Application Patients will be fitted with off-loading devices
Device: Off-loading (walking boot)
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
Procedure: Dressing Application
Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete closure of index wound
Time Frame: Up to Day 56
Up to Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to wound closure
Time Frame: Up to Day 56
Up to Day 56
Proportion of patients that achieve a 50% reduction or greater in wound size
Time Frame: Day 28
Day 28
Number of product applications
Time Frame: Up to Day 56
Up to Day 56
Number of Adverse Events
Time Frame: Up to Day 56
Up to Day 56
Number of patients with worsening of wound by ≥50% increase in size
Time Frame: Up to Day 56
Up to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osiris Therapeutics

Investigators

  • Study Director: Sharron McCulloch, Director, Clinical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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