Effectiveness of Aurix Therapy in Pressure Ulcers

A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: Aurix

Detailed Description

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Arcadia, California, United States, 91007
      • Recruiting
      • Methodist Hospital Wound Care Center
    • Montebello, California, United States, 90640
      • Recruiting
      • Beverly Hospital Wound and Hyperbaric Center
    • Visalia, California, United States, 93277
      • Recruiting
      • Kaweah Delta Rehabiliation Hospital
  • Connecticut
    • Bristol, Connecticut, United States, 06410
      • Recruiting
      • Bristol Hospital Wound Care Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont
  • Idaho
    • Meridian, Idaho, United States, 86342
      • Recruiting
      • St. Luke's Wound and Hyperbaric Center
  • Illinois
    • Freeport, Illinois, United States, 61032
      • Recruiting
      • The Center for Wound Healing at FHN
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center - Center for Wound Healing
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • Recruiting
      • St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
  • New York
    • Harris, New York, United States, 12742
      • Recruiting
      • Catskill Regional Medical Center - Wound Healing Center
    • Middletown, New York, United States, 10940
      • Recruiting
      • Orange Regional
      • Contact: Jessica Hinson; Phone Number: 845-333-7706; Email: jessica.hinson@restorixhealth.com
    • Niagara Falls, New York, United States, 14301
      • Recruiting
      • The Wound Center of Niagara
  • North Carolina
    • Jacksonville, North Carolina, United States, 28546
      • Recruiting
      • Onslow Memorial Hospital - Wound Care and Hyperbaric Center
  • Pennsylvania
    • Chester, Pennsylvania, United States, 19013
      • Recruiting
      • The Center for Wound Healing Crozer Chester Medical Center
    • Langhorne, Pennsylvania, United States, 19047
      • Terminated
      • Aria Health Bucks Wound Center
    • Philadelphia, Pennsylvania, United States, 19124
      • Terminated
      • Aria Health Frankford Wound Care Center
  • Texas
    • Houston, Texas, United States, 77024
      • Recruiting
      • Memorial Hermann Memorial City
    • Houston, Texas, United States, 77074
      • Recruiting
      • Memorial Hermann South West
    • Houston, Texas, United States, 77089
      • Recruiting
      • Memorial Hermann South East
    • Katy, Texas, United States, 77450
      • Recruiting
      • Memorial Hermann Katy Rehab
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • Recruiting
      • St. Mary's Wound and Hyperbaric Center
    • Huntington, West Virginia, United States, 25703
      • Recruiting
      • The Center for Wound Healing Cabell Huntington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Medicare eligible
2. ≥18 years of age
3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
5. For subjects with potentially multiple eligible PUs, 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 3 cm2 and 200 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate pressure relief 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. Stage I pressure ulcers
3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
6. Patients on chemotherapeutic agents or any malignancy in the wound area
7. Subjects who are cognitively impaired
8. Serum albumin of less than 2.5 g/dL
9. Plasma Platelet count of less than 100 x 109/L
10. Hemoglobin of less than 10.5 g/dL
11. Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
12. Life expectancy of < 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aurix + UCC; 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 and usual and customary care, which can include advanced therapeutics.	Device: Aurix; Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
No Intervention: Usual and Customary Care; 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 usual and customary care, which can include advanced therapeutics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Heal	Compare complete wound healing at 16 weeks for all pressure ulcers treated with Aurix plus standard of care with patients randomized to usual and customary care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of healed ulcers	Proportion of patients with completely healed pressure ulcers	16 weeks
W-QOL (Quality of Life with Chronic Wounds) score	Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 weeks	16 weeks

Collaborators and Investigators

• Sponsor: Nuo Therapeutics

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Non Healing Wound
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CM004 Gold

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No