ChiCTR‐TRC‐00000325.

Trial name or title	A prospective, randomised, controlled trial of autologous platelet‐rich plasma gel to treat refractory dermal ulcer
Methods	Randomised controlled study
Participants	Country: China. Number randomised (patients): 100 Wound aetiology: Mixed Age: 18 years and older Sex: male and female Inclusion criteria:18 years or older. Standard therapy of dermal ulcer for 2 to 6 weeks, was ineffective. ABI < 0.6 or good blood supply to the ulcer. Fasting blood glucose < 8 mmol/L. Postprandial blood glucose < 11 mmol/L. Infection or osteomyelitis well controlled. Bood pressure < 160/90 mmHg. No use of immunosuppressor or its dosage maintained in recent three weeks. No severe heart, lung, liver or renal dysfunctions, blood or psychological disease. The patient accepts to participate and sign the information consent form Exclusion criteria: Diabetic acute complications. Severe infection or uncontrolled osteomyelitis. Pregnant and lactating women. Allergic history to several drugs. Myocardial infarction, arrhythmia or cerebral infarction in recent 3 to 6 months, cardiac dysfunction, COPD, or hepatocirrhosis. Ulcer caused by malignant tumour. The patient received radiotherapy, chemotherapy, immunosuppressant or overdose of glucocorticoid therapy in recent 3 weeks. Anaemia (Hb < 90 g/L), thrombocytopenia, platelet count < 100×10^9/L, leukaemia; psychological disease. Poor compliance. The patient took part in other new drug clinical trials in recent 3 months
Interventions	Experimental: PRP gel Comparator: Standard treatment consists of daily topical washing, cleaning, debridement and dressing changing of the wounds
Outcomes	Primary outcome: Variation of ulcer area and volume Secondary outcomes: Blood and urine routine examination, blood glucose levels, lipid profiles, bacterial culture on ulcer, and HbA1c
Starting date	January 2007
Contact information	Wang Chun; Department of Endocrinology and Metabolism, West China Hospital, Guoxue Lane 37#, Chengdu, Sichuan; snoopywc@163.com
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