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Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352480
Recruitment Status : Unknown
Verified January 2018 by Nuo Therapeutics.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nuo Therapeutics

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: Aurix Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of amputations [ Time Frame: 12 weeks ]
    Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.

  2. Proportion of completely healed ulcers [ Time Frame: 12 weeks ]
    Proportion of patients with completely healed diabetic foot ulcers

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352480


Contacts
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Contact: Stacy Gardner 240-406-1816 sgardner@nuot.com

Locations
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Sponsors and Collaborators
Nuo Therapeutics
Investigators
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Study Director: Peter Clausen, PhD Nuo Therapeutics
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Responsible Party: Nuo Therapeutics
ClinicalTrials.gov Identifier: NCT02352480    
Other Study ID Numbers: CM002 Gold
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nuo Therapeutics:
Non Healing Wound
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases