Effectiveness of Aurix Therapy in Venous Leg Ulcers

A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

Study Overview

• Status: Unknown
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Device: Aurix

Detailed Description

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, randomized trial in which venous leg ulcers will be treated using Aurix and standard of care and compared 1:1 to patients receiving undefined Usual and Customary Care (UCC).

• Study Type: Interventional
• Enrollment (Anticipated): 640
• 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
      • Not yet recruiting
      • The Center for Wound Healing at FHN
      • Contact: Chad Haskell; Phone Number: 815-599-7410
  • 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
      • Contact: Jessica Johnston; Phone Number: 845-794-4620; Email: jessica.johnston@restorixhealth.com
    • 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
    • Jacksonville, North Carolina, United States, 28546
      • Recruiting
      • Onslow Memorial Hospital Wound Care and Hyperbaric Center
      • Contact: Brandi Moore, RN; Phone Number: 910-577-4977; Email: brandi.moore@restorixhealth.com
  • Ohio
    • Circleville, Ohio, United States, 43113
      • Recruiting
      • Berger Wound Healing Center
      • Contact: Laura Berger, RN; Phone Number: 740-420-8321
  • Pennsylvania
    • Chester, Pennsylvania, United States, 19013
      • Recruiting
      • The Center for Wound Healing Crozer Chester Medical 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
  • Washington
    • Bremerton, Washington, United States, 98310
      • Recruiting
      • Harrison Wound Care & Hyperbaric Medicine
      • Contact: Deborah McRae; Phone Number: 360-744-2196
  • 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. Proven venous disease
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected as 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 2 cm2 and 200 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate compression 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 index wound by Aurix
3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, 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.

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	Aurix plus standard of care versus usual and customary care only. 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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of wounds healed	Comparison of proportion of wounds healed over 12 weeks	12 weeks
Change in Quality of Life with Chronic Wounds (W-QOL) Score	Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks	12 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; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: CM003 Gold

Plan for Individual participant data (IPD)

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