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

Completed · Phase 4

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT01596920

Run by

Osiris Therapeutics

People needed

97

Starts

2012-04-01

Expected to finish

2014-03-01

Last updated by the study team

2014-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• Patient has untreated alcohol or substance abuse at the time of screening
• Pregnant women
• Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
• Patient has allergy to primary or secondary dressing materials used in this trial
• Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies

Where it is running

• Institute for Advanced Wound Care at Baptist Medical — Montgomery, Alabama, United States
• Clinical Trials of Arizona, Inc. — Glendale, Arizona, United States
• ILD Laser and Research Center — Encinitas, California, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• River City Clinical Research — Jacksonville, Florida, United States
• Aiyan Diabetes Center — Evans, Georgia, United States
• Ocean County Foot and Ankle Surgical Associates — Toms River, New Jersey, United States
• UNC at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Blair Orthopedics Associates, Inc — Altoona, Pennsylvania, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Clincal Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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