Diabetic Foot UlcersNCT02352480
Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
A study testing Aurix in people with Diabetic Foot Ulcers, run by Nuo Therapeutics at 20 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Aurix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 20 sitesUnited States
- Study dates
- Jan 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medicare eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- 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)
- 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)
- Debrided ulcer size between 0.5 cm2 and 50 cm2
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- Subject has received UCC care for ≥ 2 weeks at treating wound clinic
- Demonstrated adequate offloading regimen
- Duration ≥ 1 month at first visit
- Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
Who cannot join
- 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 the index wound by Aurix
- Ulcer not of DFU pathophysiology (e.g., venous, 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
Show all 9Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Methodist Hospital Wound Care Center
Arcadia, California, 91007
Anne Villarama, 626-898-8927
- Recruiting
Piedmont
Atlanta, Georgia, 30309
Ronald Devine, MD, 404-351-8873
Teri Biven, 404-351-8873
- Recruiting
Tufts Medical Center - Center for Wound Healing
Boston, Massachusetts, 02111
Kathryne Beasley, 617-636-5287, kbeasley@tuftsmedicalcenter.org
Geneve Allison, MD
- Recruiting
Bristol Hospital Wound Care Center
Bristol, Connecticut, 06410
Kristopher Jones, 860-585-3397, kristopher.jones@restorixhealth.com
- Recruiting
The Center for Wound Healing Crozer Chester Medical Center
Chester, Pennsylvania, 19013
Christopher Barrett, DPM, 610-619-8400, christopher.barrett@restorixhealth.com
- Recruiting
The Center for Wound Healing at FHN
Freeport, Illinois, 61032
Casey Euell, RN, 815-599-7410, Ceuell1@fhn.org
- Recruiting
Catskill Regional Medical Center - Wound Healing Center
Harris, New York, 12742
Jennifer Johnston, 845-794-4620, jennifer.johnston@restorixhealth.com
- Recruiting
Memorial Hermann Memorial City
Houston, Texas, 77024
Rachel Shafer, 713-242-4325, rachel.shafer@restorixhealth.com
- Recruiting
Memorial Hermann South West
Houston, Texas, 77074
Katherine Stubbs, 713-456-6100, katherine.stubbs@memorialhermann.org
- Recruiting
Memorial Hermann South East
Houston, Texas, 77089
Eber Lopez, 832-658-5100, eber.lopez@memorialhermann.org
- Recruiting
St. Mary's Wound and Hyperbaric Center
Huntington, West Virginia, 25702
Sabrina Briggs, RN, 304-399-7450
- Recruiting
The Center for Wound Healing Cabell Huntington Hospital
Huntington, West Virginia, 25703
Brandi Dillon, RN, 304-399-3510
- Recruiting
Onslow Memorial Hospital - Wound Care and Hyperbaric Center
Jacksonville, North Carolina, 28546
Brandi Moore, 910-577-4977, brandi.moore@restorixhealth.com
- Recruiting
Memorial Hermann Katy Rehab
Katy, Texas, 77450
Jamey Rush, 281-579-5542, jamey.rush@memorialhermann.org
- Recruiting
St. Luke's Wound and Hyperbaric Center
Meridian, Idaho, 86342
Lydia Nixt, 208-489-4326, nixtl@slhs.org
Warren Gude
- Recruiting
Orange Regional
Middletown, New York, 10940
Jessica Hinson, 845-333-7706, jessica.hinson@restorix.health.com
Inocencia Carrano
- Recruiting
Beverly Hospital Wound and Hyperbaric Center
Montebello, California, 90640
Omar Sabha, 323-726-1222
- Recruiting
The Wound Center of Niagara
Niagara Falls, New York, 14301
Cassandra Laflair, RN, 716-278-4424
- Recruiting
St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine
Pontiac, Michigan, 48341
Victoria Cardwell, RN, 248-858-2606
- Recruiting
Kaweah Delta Rehabiliation Hospital
Visalia, California, 93277
Klara Bergholdt, 559-624-3944, kbergtho@kdhcd.org
Beth Hirsch, NP
About this study
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
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
Read the 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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Aurix
- Keywords
- Non Healing Wound
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AurixDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aurix + UCC | Experimental | 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. Receives: Device: Aurix |
| Usual and Customary Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Time to heal
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.
Measured: 12 weeks
Secondary outcomes (3)
Incidence of amputations
Frequency of lower extremity amputations; major/minor amputations will be tabulated but not tested.
Measured: 12 weeks
Proportion of completely healed ulcers
Proportion of patients with completely healed diabetic foot ulcers
Measured: 12 weeks
W-QOL (Quality of life with chronic wounds) score
Change in mean W-QOL (Quality of life with Chronic Wounds) score between baseline and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Clausen, PhD, Study director, Nuo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352480
- Sponsor's protocol ID
- CM002 Gold
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02352480
- Acronym / sponsor ID
- CM002 Gold
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Non Healing Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Nuo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aurix + UCC | Experimental | Device: AurixSubjects 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. |
| Usual and Customary Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Medicare eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- 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)
- 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)
Key exclusion criteria (9 listed)
- 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 the index wound by Aurix
- Ulcer not of DFU pathophysiology (e.g., venous, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AurixAurix 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. | Device | Aurix + UCC |
Primary outcome
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.
3 secondary outcomes
Incidence of amputations
Time frame: 12 weeks
Proportion of completely healed ulcers
Time frame: 12 weeks
W-QOL (Quality of life with chronic wounds) score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Clausen, PhD study director
Nuo Therapeutics
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aurix in people with Diabetic Foot Ulcers, run by Nuo Therapeutics at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacy Gardner (240-406-1816, sgardner@nuot.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to heal (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.