Effectiveness of Aurix Therapy in Venous Leg Ulcers

Venous Leg Ulcers Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352454
• Other study ID #: CM003 Gold
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 23, 2018
• Start date: February 2015
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Nuo Therapeutics
• Contact: Stacy Gardner
• Phone: 240-406-1816
• Email: sgardner[@]nuot.com
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Hospital Wound Care Center	Arcadia	California
United States	Piedmont	Atlanta	Georgia
United States	Tufts Medical Center - Center for Wound Healing	Boston	Massachusetts
United States	Harrison Wound Care & Hyperbaric Medicine	Bremerton	Washington
United States	Bristol Hospital Wound Care Center	Bristol	Connecticut
United States	The Center for Wound Healing Crozer Chester Medical Center	Chester	Pennsylvania
United States	Berger Wound Healing Center	Circleville	Ohio
United States	The Center for Wound Healing at FHN	Freeport	Illinois
United States	Catskill Regional Medical Center - Wound Healing Center	Harris	New York
United States	Memorial Hermann Memorial City	Houston	Texas
United States	Memorial Hermann South East	Houston	Texas
United States	Memorial Hermann South West	Houston	Texas
United States	St. Mary's Wound and Hyperbaric Center	Huntington	West Virginia
United States	The Center for Wound Healing Cabell Huntington Hospital	Huntington	West Virginia
United States	Onslow Memorial Hospital - Wound Care and Hyperbaric Center	Jacksonville	North Carolina
United States	Onslow Memorial Hospital Wound Care and Hyperbaric Center	Jacksonville	North Carolina
United States	Memorial Hermann Katy Rehab	Katy	Texas
United States	St. Luke's Wound and Hyperbaric Center	Meridian	Idaho
United States	Orange Regional	Middletown	New York
United States	Beverly Hospital Wound and Hyperbaric Center	Montebello	California
United States	The Wound Center of Niagara	Niagara Falls	New York
United States	St Joseph Mercy Oakland Hospital Center for Wound Care and Hyperbaric Medicine	Pontiac	Michigan
United States	Kaweah Delta Rehabiliation Hospital	Visalia	California

Sponsors (1)

Lead Sponsor	Collaborator
Nuo Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of wounds healed	Comparison of proportion of wounds healed over 12 weeks	12 weeks
Secondary	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	12 weeks