A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Venous Leg Ulcers
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Venous Leg Ulcers
- Sponsor
- Cytomedix
- Locations
- 1
- Primary Endpoint
- Time to Heal
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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)
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Time to Heal
Time Frame: 12 weeks
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).
Secondary Outcomes
- Proportion of wounds healed(12 weeks)
- Change in Quality of Life with Chronic Wounds (W-QOL) Score(12 weeks)