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GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds

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ClinicalTrials.gov Identifier: NCT02260609
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Osiris Therapeutics

Brief Summary:
A multicenter, open-label, single-arm study to evaluate the safety and efficacy of GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or bone.

Condition or disease Intervention/treatment Phase
Complex Diabetic Foot Wounds Other: Grafix® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety and Efficacy of GrafixCORE® for the Treatment of Complex Diabetic Foot Wounds With Exposed Tendon and/or Bone
Study Start Date : October 2014
Actual Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open-Label
Grafix®: Cryopreserved Placental Membrane
Other: Grafix®

The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.

Patients will be treated for up to 16 weeks.

Patients will be evaluated at screening and then weekly throughout the study or until wound closure.

Other Names:
  • Tissue
  • Allograft Tissue




Primary Outcome Measures :
  1. 100% granulation of wound as determined by the investigator [ Time Frame: Up to 16 weeks after the Initial Treatment Visit ]

Secondary Outcome Measures :
  1. Time to 100% granulation [ Time Frame: Up to 16 weeks after the Initial Treatment Visit ]
  2. Number of applications of Grafix® [ Time Frame: Up to 16 weeks after the Initial Treatment Visit ]
  3. Measurement of percent wound area reduction as determined by the investigator [ Time Frame: Up to 16 weeks after the Initial Treatment Visit ]
  4. Closure of wound defined by 100% re-epithelialization [ Time Frame: Up to 16 weeks after the Initial Treatment Visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 years and 85 years of age inclusive, as of the date of screening
  2. Confirmed diagnosis of Type I or Type II Diabetes
  3. Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
  4. Wound is located on the foot below the malleoli
  5. Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
  6. Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
  7. Patient has adequate circulation to the foot as documented by either:

    • Ankle Brachial Index (ABI) ≥ 0.5 and ≤ 1.2, or
    • In patients with non-compressible ankle vessels, a Toe BP ≥ 40 mmHg or TcPO2 > 30 mmHg, or
    • Skin perfusion pressure > 30 mmHg

Exclusion Criteria:

  1. Index Wound is of non-diabetic pathophysiology
  2. Gangrene is present on any part of the affected foot
  3. Index Wound is over a Charcot deformity
  4. The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
  5. Patient has a glycated hemoglobin A1 (HbA1c) level of >14%
  6. Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
  7. Patient has a wound within 15cm of the Index Ulcer identified for study consideration
  8. Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
  9. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  10. Current evidence of osteomyelitis, cellulitis, or other evidence of infection including fever or pus drainage from the wound site
  11. Patient has active malignancy other than non-melanoma skin cancer
  12. Patient's random blood sugar is >450 mg/dl at screening
  13. Patient has untreated alcohol or substance abuse at the time of screening, or is deemed to be non-adherent to the protocol by the Investigator
  14. Pregnant women
  15. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
  16. Patient has allergy to primary or secondary dressing materials used in this trial
  17. Patient has had within the last 14 days, or is currently undergoing, or is planning for wound treatments with enzymes, growth factors, living skin, dermal substitutes or other advanced biological therapies
  18. In the opinion of the Investigator, the patient is unsuitable for participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260609


Locations
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United States, Arizona
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, Florida
Miami VA
Miami, Florida, United States, 33125
United States, Massachusetts
South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Sponsors and Collaborators
Osiris Therapeutics

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Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT02260609     History of Changes
Other Study ID Numbers: Osiris Protocol 310
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Keywords provided by Osiris Therapeutics:
Complex Wound
Diabetic Foot Ulcer
DFU
GrafixCORE
Exposed tendon
Exposed bone
Allograft tissue
Additional relevant MeSH terms:
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Diabetic Foot
Wounds and Injuries
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies