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

NCT02260609 | Completed Phase 4

• 1 other identifier: Osiris Protocol 310
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

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.

Conditions

Complex Diabetic Foot Wounds

Keywords

Complex Wound; Diabetic Foot Ulcer; DFU; GrafixCORE; Exposed tendon; Exposed bone; Allograft tissue

Outcome Measures

Primary Outcomes (1)

• 100% granulation of wound as determined by the investigator

  Up to 16 weeks after the Initial Treatment Visit

Secondary Outcomes (4)

• Time to 100% granulation

  Up to 16 weeks after the Initial Treatment Visit

• Number of applications of Grafix®

  Up to 16 weeks after the Initial Treatment Visit

• Measurement of percent wound area reduction as determined by the investigator

  Up to 16 weeks after the Initial Treatment Visit

• Closure of wound defined by 100% re-epithelialization

  Up to 16 weeks after the Initial Treatment Visit

Study Arms (1)

Open-Label

OTHER

Grafix®: Cryopreserved Placental Membrane

Other: Grafix®

Interventions

Grafix® OTHER

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.

Also known as: Tissue, Allograft Tissue

Open-Label

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (4)

Carl T. Hayden Medical Research Foundation

Phoenix, Arizona, 85012, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Miami VA

Miami, Florida, 33125, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

US (4)