Venous Leg Ulcers
Conditions
Keywords
Non Healing Wound
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).
Interventions
DEVICEAurix
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.
Sponsors
Cytomedix
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Heal | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of wounds healed | 12 weeks | Comparison of proportion of wounds healed over 12 weeks |
| Change in Quality of Life with Chronic Wounds (W-QOL) Score | 12 weeks | Change in mean Quality of Life with Chronic Wounds (W-QOL) score between baseline and at 12 weeks |
Countries
United States
Outcome results
None listed