Effectiveness of Aurix Therapy in Venous Leg Ulcers

NCT02940587 | Withdrawn Phase 4

• 1 other identifier: CM003 Gold
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

  Primary endpoint is time to wound healing after 12 weeks com pared with case matched controls receiving standard of care. 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

• Cytomedix: lead

Study Sites (1)

St. Luke's Intermountain Research

Boise, Idaho, 83702, United States

Location

Study Officials

• Peter Clausen, PhD

  Nuo Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2015-01

Locations

US (1)