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Effectiveness of Aurix Therapy in Pressure 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: NCT02352467
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 pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Aurix Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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 Stage II-IV Pressure Ulcers
Study Start Date : February 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 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.



Primary Outcome Measures :
  1. Time to Heal [ Time Frame: 16 weeks ]
    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).


Secondary Outcome Measures :
  1. Proportion of healed ulcers [ Time Frame: 16 weeks ]
    Proportion of patients with completely healed pressure ulcers

  2. W-QOL (Quality of Life with Chronic Wounds) score [ Time Frame: 16 weeks ]
    Change in mean W-QOL (Quality of Life with Chronic Wounds) score between baseline and 16 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. 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.

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): NCT02352467


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

Locations
Show Show 22 study locations
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: NCT02352467    
Other Study ID Numbers: CM004 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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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases