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Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcers

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aurix
Sponsored by
Nuo Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Non Healing Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Medicare eligible
  2. ≥18 years of age
  3. Type I or II diabetes requiring medical treatment as determined by the physician
  4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
  5. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
  6. Debrided ulcer size between 0.5 cm2 and 50 cm2
  7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
  8. Demonstrated adequate offloading regimen
  9. Duration ≥ 1 month at first visit
  10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

  1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
  2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by Aurix
  3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
  4. Patients on chemotherapeutic agents or any malignancy in the wound area
  5. Subjects who are cognitively impaired
  6. Serum albumin of less than 2.5 g/dL
  7. Plasma Platelet count of less than 100 x 109/L
  8. Hemoglobin of less than 10.5 g/dL
  9. Subject has inadequate venous access for repeated blood draw required for Aurix administration.

Sites / Locations

  • Methodist Hospital Wound Care CenterRecruiting
  • Beverly Hospital Wound and Hyperbaric CenterRecruiting
  • Kaweah Delta Rehabiliation HospitalRecruiting
  • Bristol Hospital Wound Care CenterRecruiting
  • PiedmontRecruiting
  • St. Luke's Wound and Hyperbaric CenterRecruiting
  • The Center for Wound Healing at FHNRecruiting
  • Tufts Medical Center - Center for Wound HealingRecruiting
  • St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric MedicineRecruiting
  • Catskill Regional Medical Center - Wound Healing CenterRecruiting
  • Orange RegionalRecruiting
  • The Wound Center of NiagaraRecruiting
  • Onslow Memorial Hospital - Wound Care and Hyperbaric CenterRecruiting
  • The Center for Wound Healing Crozer Chester Medical CenterRecruiting
  • Memorial Hermann Memorial CityRecruiting
  • Memorial Hermann South WestRecruiting
  • Memorial Hermann South EastRecruiting
  • Memorial Hermann Katy RehabRecruiting
  • St. Mary's Wound and Hyperbaric CenterRecruiting
  • The Center for Wound Healing Cabell Huntington HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aurix + UCC

Usual and Customary Care

Arm Description

Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment plus usual and customary care, which can include any advanced therapeutics.

Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week there after while receiving usual and customary care, but actual frequency of visits will be determined by the treating physician. Usual and customary care, which can include any advanced therapeutics.

Outcomes

Primary Outcome Measures

Time to heal
The primary endpoint of the trial is determine the time to heal diabetic foot ulcers treated with Aurix and Standard of Care at 12 weeks. Comparison will be made with the control arm of subjects treated only with Standard of Care.

Secondary Outcome Measures

Incidence of amputations
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Proportion of completely healed ulcers
Proportion of patients with completely healed diabetic foot ulcers
W-QOL (Quality of life with chronic wounds) score
Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks

Full Information

First Posted
January 28, 2015
Last Updated
January 23, 2018
Sponsor
Nuo Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02352480
Brief Title
Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
Official Title
A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in All Wagner Grades of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuo Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers
Detailed Description
Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of Aurix have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the of complete wound healing in a prospective, open-label, randomized trial in which diabetic foot ulcers will be treated using Aurix to determine the time to heal at 12 weeks. Comparison will be made on a 1:1 basis of Aurix + UCC versus control subjects receiving undefined UCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Non Healing Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aurix + UCC
Arm Type
Experimental
Arm Description
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment plus usual and customary care, which can include any advanced therapeutics.
Arm Title
Usual and Customary Care
Arm Type
No Intervention
Arm Description
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week there after while receiving usual and customary care, but actual frequency of visits will be determined by the treating physician. Usual and customary care, which can include any advanced therapeutics.
Intervention Type
Device
Intervention Name(s)
Aurix
Intervention Description
Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
Primary Outcome Measure Information:
Title
Time to heal
Description
The primary endpoint of the trial is determine the time to heal diabetic foot ulcers treated with Aurix and Standard of Care at 12 weeks. Comparison will be made with the control arm of subjects treated only with Standard of Care.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of amputations
Description
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Time Frame
12 weeks
Title
Proportion of completely healed ulcers
Description
Proportion of patients with completely healed diabetic foot ulcers
Time Frame
12 weeks
Title
W-QOL (Quality of life with chronic wounds) score
Description
Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medicare eligible ≥18 years of age Type I or II diabetes requiring medical treatment as determined by the physician The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces) For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) Debrided ulcer size between 0.5 cm2 and 50 cm2 Subject has received UCC care for ≥ 2 weeks at treating wound clinic Demonstrated adequate offloading regimen Duration ≥ 1 month at first visit Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician. Exclusion Criteria: Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by Aurix Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) Patients on chemotherapeutic agents or any malignancy in the wound area Subjects who are cognitively impaired Serum albumin of less than 2.5 g/dL Plasma Platelet count of less than 100 x 109/L Hemoglobin of less than 10.5 g/dL Subject has inadequate venous access for repeated blood draw required for Aurix administration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacy Gardner
Phone
240-406-1816
Email
sgardner@nuot.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Clausen, PhD
Organizational Affiliation
Nuo Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Methodist Hospital Wound Care Center
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Villarama
Phone
626-898-8927
Facility Name
Beverly Hospital Wound and Hyperbaric Center
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Sabha
Phone
323-726-1222
Facility Name
Kaweah Delta Rehabiliation Hospital
City
Visalia
State/Province
California
ZIP/Postal Code
93277
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klara Bergholdt
Phone
559-624-3944
Email
kbergtho@kdhcd.org
First Name & Middle Initial & Last Name & Degree
Beth Hirsch, NP
Facility Name
Bristol Hospital Wound Care Center
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristopher Jones
Phone
860-585-3397
Email
kristopher.jones@restorixhealth.com
Facility Name
Piedmont
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Devine, MD
Phone
404-351-8873
First Name & Middle Initial & Last Name & Degree
Teri Biven
Phone
404-351-8873
Facility Name
St. Luke's Wound and Hyperbaric Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
86342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia Nixt
Phone
208-489-4326
Email
nixtl@slhs.org
First Name & Middle Initial & Last Name & Degree
Warren Gude
Facility Name
The Center for Wound Healing at FHN
City
Freeport
State/Province
Illinois
ZIP/Postal Code
61032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Euell, RN
Phone
815-599-7410
Email
Ceuell1@fhn.org
Facility Name
Tufts Medical Center - Center for Wound Healing
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryne Beasley
Phone
617-636-5287
Email
kbeasley@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Geneve Allison, MD
Facility Name
St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Cardwell, RN
Phone
248-858-2606
Facility Name
Catskill Regional Medical Center - Wound Healing Center
City
Harris
State/Province
New York
ZIP/Postal Code
12742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Johnston
Phone
845-794-4620
Email
jennifer.johnston@restorixhealth.com
Facility Name
Orange Regional
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Hinson
Phone
845-333-7706
Email
jessica.hinson@restorix.health.com
First Name & Middle Initial & Last Name & Degree
Inocencia Carrano
Facility Name
The Wound Center of Niagara
City
Niagara Falls
State/Province
New York
ZIP/Postal Code
14301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Laflair, RN
Phone
716-278-4424
Facility Name
Onslow Memorial Hospital - Wound Care and Hyperbaric Center
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Moore
Phone
910-577-4977
Email
brandi.moore@restorixhealth.com
Facility Name
The Center for Wound Healing Crozer Chester Medical Center
City
Chester
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barrett, DPM
Phone
610-619-8400
Email
christopher.barrett@restorixhealth.com
Facility Name
Memorial Hermann Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Shafer
Phone
713-242-4325
Email
rachel.shafer@restorixhealth.com
Facility Name
Memorial Hermann South West
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Stubbs
Phone
713-456-6100
Email
katherine.stubbs@memorialhermann.org
Facility Name
Memorial Hermann South East
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eber Lopez
Phone
832-658-5100
Email
eber.lopez@memorialhermann.org
Facility Name
Memorial Hermann Katy Rehab
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamey Rush
Phone
281-579-5542
Email
jamey.rush@memorialhermann.org
Facility Name
St. Mary's Wound and Hyperbaric Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Briggs, RN
Phone
304-399-7450
Facility Name
The Center for Wound Healing Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Dillon, RN
Phone
304-399-3510

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

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