Effectiveness of Aurix Therapy in Pressure Ulcers

Nuo Therapeutics

Status: Unknown

Conditions: Pressure Ulcer

Treatments: Device: Aurix

Study type: Interventional

Funder types: Industry

Identifiers

NCT02352467

CM004 Gold

Details and patient eligibility

About

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.

Full description

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Medicare eligible
2. ≥18 years of age
3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
5. For subjects with potentially multiple eligible PUs, 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)
6. Debrided ulcer size between 3 cm2 and 200 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate pressure relief 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. Stage I pressure ulcers
3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
6. Patients on chemotherapeutic agents or any malignancy in the wound area
7. Subjects who are cognitively impaired
8. Serum albumin of less than 2.5 g/dL
9. Plasma Platelet count of less than 100 x 109/L
10. Hemoglobin of less than 10.5 g/dL
11. Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
12. Life expectancy of < 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Aurix + UCC

Experimental group

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.

Treatment:

Device: Aurix

Usual and Customary Care

No Intervention group

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.