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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT01596920
First received: March 14, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcers
Other: Tissue
Other: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicenter, Adaptive Design, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Grafix® for the Treatment of Chronic Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:
  • Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, anytime up to the Day 84 Visit [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to initial wound closure [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ] [ Designated as safety issue: No ]
  • number of patients with >50% reduction in wound size by Day 28 [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ] [ Designated as safety issue: No ]
  • number of applications of Grafix® versus control [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ] [ Designated as safety issue: No ]
  • number of re-occurrences of index wound post-healing [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ] [ Designated as safety issue: No ]
  • percent of wounds achieving complete closure [ Time Frame: Up to 84 days after the Single-Blind Treatment Visits ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Grafix® Other: Tissue
Allograft Tissue Cellular Repair Matrix
Placebo Comparator: Control (non-adherent dressing) Other: Control
Non-adherent Dressing

Detailed Description:

The treatment indication is for chronic, diabetic foot ulcers (DFUs) between 1cm2 and 15cm2 located below the malleoli on the plantar or dorsal surface of the foot. Patients must have confirmed Type I or Type II Diabetes.

Patients will receive treatment every week for 12 weeks duration in the Single-Blind Treatment phase of the trial.

Patients who receive Grafix® or control will be evaluated for primary efficacy up to 84 days, and for safety and wound re-occurrence for 84 days after wound closure. Patients in the control group whose wounds are not closed at the end of treatment may be offered Grafix® in an Open-Label Treatment phase. The Open-Label Treatment phase can last up to an additional 84 days.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 years and 80 years of age inclusive, as of the date of screening
  2. Confirmed diagnosis of Type I or Type II Diabetes
  3. An Index Ulcer defined as chronic (presence of wound for > 4 weeks) but not present for more than 52 weeks at the Screening Visit
  4. Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
  5. The Index Ulcer is between 1cm2 and 15 cm2 at the Screening Visit
  6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
  7. Wound is free of necrotic debris
  8. 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).

Exclusion Criteria:

  1. Index Ulcer is of non-diabetic pathophysiology
  2. Gangrene is present on any part of the affected foot
  3. Index Ulcer is over an active Charcot deformity
  4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
  5. Patient is currently receiving dialysis
  6. Patient has a glycated hemoglobin A1c (HbA1c) level of > 12%
  7. Chronic oral steroid use > 7.5 mg daily
  8. Requiring intravenous (IV) antibiotics to treat the index wound infection
  9. Patient has an ulcer within 15cm of the Index Ulcer identified for study consideration
  10. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
  11. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  12. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
  13. Patient has active malignancy other than non-melanoma skin cancer
  14. Patient's Index Ulcer has decreased by ≥ 30% during 1-week screening period as determined by criteria provided by the Wound Core Lab
  15. Patient's random blood sugar is > 450 mg/dl at screening
  16. Patient has untreated alcohol or substance abuse at the time of screening
  17. Pregnant women
  18. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
  19. Patient has allergy to primary or secondary dressing materials used in this trial
  20. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596920

Locations
United States, Alabama
Institute for Advanced Wound Care at Baptist Medical
Montgomery, Alabama, United States, 36111
United States, Arizona
Clinical Trials of Arizona, Inc.
Glendale, Arizona, United States, 85306
United States, California
ILD Laser and Research Center
Encinitas, California, United States, 92024
United States, Florida
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
River City Clinical Research
Jacksonville, Florida, United States, 32207
United States, Georgia
Aiyan Diabetes Center
Evans, Georgia, United States, 30809
United States, New Jersey
Ocean County Foot and Ankle Surgical Associates
Toms River, New Jersey, United States, 08753
United States, North Carolina
UNC at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Blair Orthopedics Associates, Inc
Altoona, Pennsylvania, United States, 16602
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Clincal Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Osiris Therapeutics
Investigators
Study Director: Sharron E McCulloch Osiris Therapeutics, Inc
  More Information

No publications provided

Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT01596920     History of Changes
Other Study ID Numbers: Osiris 302
Study First Received: March 14, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Osiris Therapeutics:
Chronic DFUs
Diabetic Foot Ulcers

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 17, 2014