NCT02209662.

Trial name or title	Safety and efficacy study of APIC‐PRP in non‐healing diabetic foot ulcers
Methods	Multicentre, randomised, double‐blind (subject, caregiver, investigator, outcomes assessor) controlled study
Participants	Country: USA Number randomised (patients): 274 Wound aetiology: Diabetic food ulcer Age: 18 year and older. Sex: Male and female. Inclusion criteria: Age > 18 years old at the time the informed consent is signed. Diabetes type I or II). Subjects will have only one diabetic foot ulcer on the target limb (referred to as the index ulcer). Debrided ulcer size between 1 cm2 and 4 cm2. Ulcer duration ≥ 1 month at first visit and free of clinical signs of infection. Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI of ≥ 0.7 after 10 minutes of rest Exclusion criteria: Hemoglobin of less than 12 g/dL. Ulcer has increased in size by > 50% or ulcer healed by 25% or more during the run‐in screening period. History of bleeding disorder. Any malignancy other than non‐melanoma skin cancer requiring treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or corticosteroids less than 30 days before enrolment. Subject has gangrene present on any part of the affected limb. Ulcer is over a Charcot deformity of the mid‐foot or over the tarsal bones‐talus, distal calcaneus, navicular, and cuboid. Severe malnutrition or with Acquired Immunodeficiency Syndrome (AIDS), liver disease, aplastic anaemia, scleroderma, malignancy, cellulitis, suspected osteomyelitis or other evidence of systemic infection, or is Human Immunodeficiency Virus (HIV)‐positive. Subject is on dialysis
Interventions	Experimental: Cytonics Autologous Platelet Integrated Concentration (APIC‐PRP) plus standard of care Comparator: Placebo (saline) plus standard of care
Outcomes	Primary outcome: Complete wound closure within 12 weeks Secondary outcomes: Improvement in wound healing trajectory of diabetic food ulcer over the 12‐week treatment period between the APIC‐PRP + standard of care groups and standard of care alone groups
Starting date	October 2014
Contact information	Gaetano J Scuderi. Cytonics Corporation
Notes	Funding: Cytonics Corporation