Venous Leg Ulcer
Conditions
Keywords
venous leg ulcers, non healing wounds
Brief summary
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of 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. AutoloGel 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, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care
Interventions
DEVICEAutoloGel
Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds
Sponsors
Cytomedix
Study design
Allocation
NA
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/Medicaid 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. 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. Demonstrated adequate compression regimen 8. Duration ≥ 1 month at first visit 9. 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 AutoloGel 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 AutoloGel 3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) 4. Any malignancy other than non-melanoma skin cancer 5. Subjects who are cognitively impaired and do not have a healthcare proxy 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 AutoloGel Administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound closure | 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 |
| Frequency of ulcer recurrence | 1 year | Frequency of ulcer recurrence over a 1 year period post treatment; recurrence is defined as any new ulcer appearing on the leg after the index ulcer has healed. |
| 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 |
| Number of patients with adverse events as a measure of tolerability | 12 weeks | Frequency and severity of treatment emergent adverse events |
Countries
United States
Outcome results
None listed