Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers

Inclusion Criteria:

• Male or Female 18 to 85 years of age
• Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic foot ulcer) which is at least 4 weeks old
• Index foot ulcer located on the plantar, medial or lateral aspect of the foot (including all toe surfaces)
• Wound area (length x width) measurement must be between 0.5 cm^2 and 10 cm^2, inclusive
• If more than one non-healing ulcers is present, the largest wound will be selected
• Index ulcer must be clinically non-infected
• Full-thickness ulcer without exposure of bone, muscle, ligament or tendon
• Written informed consent must be obtained from either the patient or the patients legally acceptable representative prior to enrollment

Exclusion Criteria:

• Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACD-A))
• Smokers and individuals with systemic disease or history of anticoagulant, immuno-suppressive or antibiotic therapy in the last 3 months
• Platelet count < 105 x 10^3/ uL (according to CBC)
• Hemoglobin level < 10 g/dL (according to CBC)
• Wound is clinically infected
• Presence of platelet dysfunction syndrome or critical thrombocytopenia
• Bleeding disorders, collagen vascular disease or severe cardiovascular disorder
• Any malignancy other than non-melanoma skin cancer
• Patient is currently receiving or has received radiation or chemotherapy within 3 months prior to treatment
• If female, patient is pregnant, nursing or plans to become pregnant during the duration of the study
• Subject has inadequate venous access for blood draw required for PRP preparation
• Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
• Subject is on dialysis or has uncontrolled sugar levels