Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers

A multi-center, prospective, randomized study to evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic Diabetic Foot Ulcers.

Inclusion criteria

• Female or Male, plus ≥18 years of age at the time the study Informed Consent is signed.
• Proven and medically diagnosed chronic DFU. Subject's ulcer extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule.
• Type I or II diabetes mellitus as determined by the physician / provider and undergoing therapy for glycemic control.
• At randomization, the DFU must be assessable using the Wagner Scale Grades 1-5, specifically Grades 1 or 2 (full-thickness ulcer).
• The DFU is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces).
• For subjects with potentially multiple eligible DFUs, the ulcer which best fits the study criteria will be selected as the 'target ulcer' for study. There must be at least 4 cm between the target ulcer and other ulcers.
• At randomization, the target DFU surface area is between 1 cm2 (minimum) and 50 cm2 (maximum) post debridement by the study wound care provider.
• The target DFU has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4-weeks.
• Target DFU has been deemed present for ≥ 1-month (4-weeks), and had a maximum of 52-weeks of SOC prior to the first study screening visit.
• Demonstrated adequate offloading regime. Patients require 4 weeks of documented offloading prior to enrollment in the trial.
• Post-debridement, subject's wound is free of necrotic debris and appears to be made up of healthy vascularized tissue.
• The target ulcer is free of clinical signs of infection, identified by inflammation (redness, warmth, swelling, tenderness, or pain) or purulent exudates (Lipsky et al, 2012).
• Subject has adequate circulation to the study foot as evidenced by an ankle-brachial index (ABI) of ≥ 0.65-1.30 after 10 minutes of rest.
• Subject must be able to read, speak, understand, and sign the Informed Consent Form.
• Female subjects must have a negative urine pregnancy test prior to the first treatment.
• Willing and able to adhere to the study protocol, plus treatment and follow-up schedule and pre/post-treatment care instructions.
• Willing to have photographs taken of the target wound and agree to the use of photographs for presentation, educational or marketing purposes.
• Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.

Exclusion criteria

• Ulcer is not medically diagnosed as DFU pathophysiology.
• At randomization, the DFU is a zero on the Wagner Scale.
• Presence of another wound within the boundaries of the target DFU; especially if it is being concurrently treated and may interfere with the wound applicable for this study.
• Presence of a clinically confirmed, infected wound, thereby requiring antibiotics. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky et al, 2012).
• Hemoglobin of less than 10.5 g/dL.
• Serum Albumin of less than 2.5 g/dL.
• Plasma Platelet count of less than 100 x 109/L.
• Inadequate amount of blood drawn to produce sufficient PRFM. One complete PRFM preparation requires 10ml of blood drawn.
• Target ulcer area decreases by ≥ 20% prior to and / or during 2-week screening/run-in period.
• Subject's target ulcer has tunnels or sinus tracts that cannot be completely debrided.
• Subject's target ulcer exposes tendon or bone.
• Subject has inadequate venous access for repeated blood draw required for centrifugation and completion of the treatment procedures.
• Subject has severe malnutrition as evidenced by albumin < 2.5 g/dL. A previous serum albumin test that is <6 weeks old is sufficient for this criteria.
• Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
• Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation. Received topical steroids, systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit; received radiation therapy or chemotherapy within previous 6 months.
• The target ulcer demonstrates underlying osteomyelitis, defined as infection in the bone, identified by fever, chills, or pain in the infected bone (for the purpose of the study, any exposed bone will be classified as osteomyelitis).
• Participant is expected to undergo a medical procedure for and/or around the target ulcer location during the study duration, includes any advanced wound care therapies or malignancy-related interventions in nearby wounds.
• Subject has radiographic evidence consistent with diagnosis of active Charcot foot. Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which reconstruction or offloading has not taken place.
• No history of Type I or II diabetes mellitus.
• Known to be sensitive to device components listed within the IFU.
• The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
• History of malignant tumors in the target area.
• Pregnant and/or breastfeeding or planning to become pregnant during the study.
• Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g. gangrene, infections, frequent hospitalization, etc.).
• As per the Investigator's discretion, any physical or mental impairment which might make it unsafe for the subject to participate in this study. This includes subjects who are cognitively impaired and therefore cannot give consent, and do not have a healthcare proxy.
• Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
• History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• History of radiation to the target area, currently undergoing treatment for skin cancer in the target area, or undergoing systemic chemotherapy for the treatment of cancer.