Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

January 23, 2018 updated by: Nuo Therapeutics

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • 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
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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 plus usual and customary care, which can include any advanced therapeutics.
Device: Aurix
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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to heal
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuo Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM002 Gold

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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