Effectiveness of Aurix Therapy in Venous Leg Ulcers

NCT02352454 | Unknown DMC

• 1 other identifier: CM003 Gold
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 23

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)

Conditions

Venous Leg Ulcers

Keywords

Non Healing Wound

Outcome Measures

Primary Outcomes (1)

• Time to Heal

  Aurix plus standard of care versus usual and customary care only. 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).

  12 weeks

Secondary Outcomes (2)

• Proportion of wounds healed

  12 weeks

• Change in Quality of Life with Chronic Wounds (W-QOL) Score

  12 weeks

Study Arms (2)

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 and usual and customary care, which can include advanced therapeutics.

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 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.

Interventions

Aurix DEVICE

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.

Aurix + UCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuo Therapeutics: lead

Study Sites (23)

Methodist Hospital Wound Care Center

Arcadia, California, 91007, United States

RECRUITING

Beverly Hospital Wound and Hyperbaric Center

Montebello, California, 90640, United States

RECRUITING

Kaweah Delta Rehabiliation Hospital

Visalia, California, 93277, United States

RECRUITING

Bristol Hospital Wound Care Center

Bristol, Connecticut, 06410, United States

RECRUITING

Piedmont

Atlanta, Georgia, 30309, United States

RECRUITING

St. Luke's Wound and Hyperbaric Center

Meridian, Idaho, 86342, United States

RECRUITING

The Center for Wound Healing at FHN

Freeport, Illinois, 61032, United States

NOT YET RECRUITING

Tufts Medical Center - Center for Wound Healing

Boston, Massachusetts, 02111, United States

RECRUITING

St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine

Pontiac, Michigan, 48341, United States

RECRUITING

Catskill Regional Medical Center - Wound Healing Center

Harris, New York, 12742, United States

RECRUITING

Orange Regional

Middletown, New York, 10940, United States

RECRUITING

The Wound Center of Niagara

Niagara Falls, New York, 14301, United States

RECRUITING

Onslow Memorial Hospital - Wound Care and Hyperbaric Center

Jacksonville, North Carolina, 28546, United States

RECRUITING

Onslow Memorial Hospital Wound Care and Hyperbaric Center

Jacksonville, North Carolina, 28546, United States

RECRUITING

Berger Wound Healing Center

Circleville, Ohio, 43113, United States

RECRUITING

The Center for Wound Healing Crozer Chester Medical Center

Chester, Pennsylvania, 19013, United States

RECRUITING

Memorial Hermann Memorial City

Houston, Texas, 77024, United States

RECRUITING

Memorial Hermann South West

Houston, Texas, 77074, United States

RECRUITING

Memorial Hermann South East

Houston, Texas, 77089, United States

RECRUITING

Memorial Hermann Katy Rehab

Katy, Texas, 77450, United States

RECRUITING

Harrison Wound Care & Hyperbaric Medicine

Bremerton, Washington, 98310, United States

RECRUITING

St. Mary's Wound and Hyperbaric Center

Huntington, West Virginia, 25702, United States

RECRUITING

The Center for Wound Healing Cabell Huntington Hospital

Huntington, West Virginia, 25703, United States

RECRUITING

Study Officials

• Peter Clausen, PhD

  Nuo Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Stacy Gardner

CONTACT

240-406-1816; sgardner@nuot.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)