Status:
COMPLETED
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds
Lead Sponsor:
Osiris Therapeutics
Conditions:
Complex Diabetic Foot Wounds
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Between 18 years and 85 years of age inclusive, as of the date of screening
- Confirmed diagnosis of Type I or Type II Diabetes
- Index wound graded in the Texas Classification System as Grade II-III, Stage A or C (without active infection)
- Wound is located on the foot below the malleoli
- Wound accommodates up to three (3) 5 cm x 5 cm pieces of GrafixCORE® that completely cover the wound
- Patient's wound extends through the dermis and into subcutaneous tissue with evidence of exposed muscle, tendon, bone, and/or joint capsule
- 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
- Index Wound is of non-diabetic pathophysiology
- Gangrene is present on any part of the affected foot
- Index Wound is over a Charcot deformity
- The longest dimension of the Index Wound exceeds 15 cm at the Baseline Visit
- Patient has a glycated hemoglobin A1 (HbA1c) level of \>14%
- Requiring intravenous (IV) antibiotics to treat the index wound infection at enrollment
- Patient has a wound 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 random blood sugar is \>450 mg/dl at screening
- 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
- Pregnant women
- Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
- Patient has allergy to primary or secondary dressing materials used in this trial
- 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
- In the opinion of the Investigator, the patient is unsuitable for participation in the study
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02260609
Start Date
October 1 2014
Last Update
February 2 2016
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Carl T. Hayden Medical Research Foundation
Phoenix, Arizona, United States, 85012
2
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
3
Miami VA
Miami, Florida, United States, 33125
4
South Shore Hospital
Weymouth, Massachusetts, United States, 02190