Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Memorial Hermann South West
Houston, Texas 77074
Contact:
Katherine Stubbs
713-456-6100
katherine.stubbs@memorialhermann.org

Memorial Hermann South East
Houston, Texas 77089
Contact:
Eber Lopez
832-658-5100
eber.lopez@memorialhermann.org

Memorial Hermann Katy Rehab
Katy, Texas 77450
Contact:
Jamey Rush
281-579-5542
jamey.rush@memorialhermann.org

Memorial Hermann Memorial City
Houston, Texas 77024
Contact:
Rachel Shafer
713-242-4325
rachel.shafer@restorixhealth.com

More Details

Status
Unknown status
Sponsor
Nuo Therapeutics

Study Contact

Stacy Gardner
240-406-1816
sgardner@nuot.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.