Back to resultsEffectiveness of Aurix Therapy in Venous Leg Ulcers
Primary Purpose
Venous Leg Ulcers
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aurix
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Non Healing Wound
Eligibility Criteria
Inclusion Criteria:
- Medicare eligible
- ≥18 years of age
- Proven venous disease
- 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
- 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)
- Debrided ulcer size between 2 cm2 and 200 cm2
- Subject has received UCC care for ≥ 2 weeks at treating wound clinic
- Demonstrated adequate compression regimen
- Duration ≥ 1 month at first visit
- Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician
Exclusion Criteria:
- Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
- Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
- Patients on chemotherapeutic agents or any malignancy in the wound area
- Subjects who are cognitively impaired
- Serum albumin of less than 2.5 g/dL
- Plasma Platelet count of less than 100 x 109/L
- Hemoglobin of less than 10.5 g/dL
- Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
Sites / Locations
- St. Luke's Intermountain Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Aurix + UCC
Usual and Customary Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to Heal
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
Proportion of wounds healed
Comparison of proportion of wounds healed over 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940587
Brief Title
Effectiveness of Aurix Therapy in Venous Leg Ulcers
Official Title
A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Withdrawn
Why Stopped
New record created in clinical trials due to company re-branding, and inability to list new name as the sponsor.
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytomedix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
Non Healing Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aurix + UCC
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual and Customary Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aurix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Heal
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of wounds healed
Description
Comparison of proportion of wounds healed over 12 weeks
Time Frame
12 weeks
Title
Change in Quality of Life with Chronic Wounds (W-QOL) Score
Description
Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medicare eligible
≥18 years of age
Proven venous disease
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
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)
Debrided ulcer size between 2 cm2 and 200 cm2
Subject has received UCC care for ≥ 2 weeks at treating wound clinic
Demonstrated adequate compression regimen
Duration ≥ 1 month at first visit
Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician
Exclusion Criteria:
Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
Patients on chemotherapeutic agents or any malignancy in the wound area
Subjects who are cognitively impaired
Serum albumin of less than 2.5 g/dL
Plasma Platelet count of less than 100 x 109/L
Hemoglobin of less than 10.5 g/dL
Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Clausen, PhD
Organizational Affiliation
Nuo Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
St. Luke's Intermountain Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Aurix Therapy in Venous Leg Ulcers
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