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

Sponsor

Osiris Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT02260609

Collaborator

(none)

Enrollment

Locations

Arm

7.8

Patients Per Site

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

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 :

Oct 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

100% granulation of wound as determined by the investigator [Up to 16 weeks after the Initial Treatment Visit]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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