Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers

NCT01596920 | Completed Phase 4

• 1 other identifier: Osiris 302
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 15

Brief Summary

The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator. Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue Based Product (HCT/P) under Title 21 CFR Part 1271.

Conditions

Diabetic Foot Ulcers

Keywords

Chronic DFUs; Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, anytime up to the Day 84 Visit

  Up to 84 days

Secondary Outcomes (5)

• Time to initial wound closure

  Up to 84 days after the Single-Blind Treatment Visits

• number of patients with >50% reduction in wound size by Day 28

  Up to 84 days after the Single-Blind Treatment Visits

• number of applications of Grafix® versus control

  Up to 84 days after the Single-Blind Treatment Visits

• number of re-occurrences of index wound post-healing

  Up to 84 days after the Single-Blind Treatment Visits

• percent of wounds achieving complete closure

  Up to 84 days after the Single-Blind Treatment Visits

Study Arms (2)

Grafix®

ACTIVE COMPARATOR

Other: Tissue

Control (non-adherent dressing)

PLACEBO COMPARATOR

Other: Control

Interventions

Tissue OTHER

Allograft Tissue Cellular Repair Matrix

Grafix®

Control OTHER

Non-adherent Dressing

Control (non-adherent dressing)

Eligibility Criteria

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

You may qualify if:

• Between 18 years and 80 years of age inclusive, as of the date of screening
• Confirmed diagnosis of Type I or Type II Diabetes
• An Index Ulcer defined as chronic (presence of wound for \> 4 weeks) but not present for more than 52 weeks at the Screening Visit
• Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
• The Index Ulcer is between 1cm2 and 15 cm2 at the Screening Visit
• The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
• Wound is free of necrotic debris
• Patient has adequate circulation to the foot as documented by either:
• Ankle Brachial Index (ABI) \> 0.70 and \< 1.30, or
• In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50
• In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording \[PVR\] testing).

You may not qualify if:

• Index Ulcer is of non-diabetic pathophysiology
• Gangrene is present on any part of the affected foot
• Index Ulcer is over an active Charcot deformity
• The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
• Patient is currently receiving dialysis
• Patient has a glycated hemoglobin A1c (HbA1c) level of \> 12%
• Chronic oral steroid use \> 7.5 mg daily
• Requiring intravenous (IV) antibiotics to treat the index wound infection
• Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
• Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
• Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• Patient has active malignancy other than non-melanoma skin cancer
• Patient's Index Ulcer has decreased by ≥ 30% during 1-week screening period as determined by criteria provided by the Wound Core Lab
• Patient's random blood sugar is \> 450 mg/dl at screening

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (15)

Institute for Advanced Wound Care at Baptist Medical

Montgomery, Alabama, 36111, United States

Location

Clinical Trials of Arizona, Inc.

Glendale, Arizona, 85306, United States

Location

ILD Laser and Research Center

Encinitas, California, 92024, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Aiyan Diabetes Center

Evans, Georgia, 30809, United States

Location

Ocean County Foot and Ankle Surgical Associates

Toms River, New Jersey, 08753, United States

Location

UNC at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Blair Orthopedics Associates, Inc

Altoona, Pennsylvania, 16602, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Clincal Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Histocompatibility Testing

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

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Sharron E McCulloch

  Osiris Therapeutics, Inc

  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: March 14, 2012
• First Posted: May 11, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (15)