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Effectiveness of Aurix Therapy in Venous Leg Ulcers

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ClinicalTrials.gov Identifier: NCT02940587
Recruitment Status : Withdrawn (New record created in clinical trials due to company re-branding, and inability to list new name as the sponsor.)
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Cytomedix

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 venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

Condition or disease Intervention/treatment Phase
Venous Leg Ulcers Device: Aurix Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 Venous Leg Ulcers
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 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: 12 weeks ]
    Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of 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 wounds healed [ Time Frame: 12 weeks ]
    Comparison of proportion of wounds healed over 12 weeks

  2. Change in Quality of Life with Chronic Wounds (W-QOL) Score [ Time Frame: 12 weeks ]
    Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks



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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. 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.

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): NCT02940587


Locations
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United States, Idaho
St. Luke's Intermountain Research
Boise, Idaho, United States, 83702
Sponsors and Collaborators
Cytomedix
Investigators
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Study Director: Peter Clausen, PhD Nuo Therapeutics

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Responsible Party: Cytomedix
ClinicalTrials.gov Identifier: NCT02940587     History of Changes
Other Study ID Numbers: CM003 Gold
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: January 2015

Keywords provided by Cytomedix:
Non Healing Wound

Additional relevant MeSH terms:
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Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases