GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

NCT02675855 | Completed Phase 4

• 1 other identifier: Protocol 350
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

Foot Ulcer, Diabetic

Keywords

Grafix

Outcome Measures

Primary Outcomes (1)

• Complete closure of index wound

  Up to Day 56

Secondary Outcomes (5)

• 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

Study Arms (2)

GrafixPRIME®

EXPERIMENTAL

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

Other: GrafixPRIME®; Device: Off-loading (walking boot)

Active Comparator

ACTIVE COMPARATOR

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

Procedure: Dressing Application; Device: Off-loading (walking boot)

Interventions

GrafixPRIME® OTHER

Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

GrafixPRIME®

Dressing Application PROCEDURE

Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

Active Comparator

Off-loading (walking boot) DEVICE

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; GrafixPRIME®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (3)

Unknown Facility

Arizona City, Arizona, United States

Location

Unknown Facility

California City, California, United States

Location

Unknown Facility

New Mexico, New Mexico, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Sharron McCulloch

  Director, Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)