A Prospective, Randomized, Controlled Trial of Autologous Platelet-Rich Plasma Gel to treat refractory dermal ulcer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000325

Enrollment

Unknown

Registered

2009-01-31

Start date

2007-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory dermal ulcer

Interventions

Experimental group:Based on standard treatment, Platelet-rich plasma

Control group:Standard treatment consists of daily topical washing, cleaning, debridement and dressing changing of the wounds.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. After standard therapy of dermal ulcer for 2-6 weeks, it is ineffective; 2. ABI>=0.6 or good blood supply to the ulcer. If ABI<0.6, blood supply is improved after interventional or surgery therapy; 3. Fasting blood glucose<=8mmol/L, Postprandial blood glucose<=11mmol/L; 4. Infection or osteomyelitis are well controlled; 5. Blood pressure<=160/90mmHg; 6. Immunosuppressor is not used or its dosage is maintained in recent three weeks; 7. No severe heart, lung, liver and renal dysfunctions or blood disease; 8. No psychological disease. The patient can understand the aims and potential adverse events of this clinical trial completely and sign the information consent form.

Exclusion criteria

Exclusion criteria: 1. With diabetic acute complications such as diabetic ketoacidosis and non-ketone hypertonic coma; 2. Severe infection or uncontrolled osteomyelitis; 3. Pregnant and lactation women; 4. With allergic history to several drugs or recent allergy; 5. With severe myocardial infarction, arrhythmia or cerebral infaction in recent 3~6 months, cardiac dysfunction(grade III-IV), episode of COPD, unstable hepatocirrhosis and et al; 6. Ulcer caused by malignant tumor; 7. The patient received radiotherapy, chemotherapy, immunosuppressant ot overdose of glucocorticoid therapy in recent 3 weeks; 8. With blood disease, such as anemia (Hb<90 g/L), thrombocytopenia (platelet count<100*10^9/L), leukemia; 9. With psychological disease or poor self-cognition; 10. Poor compliance; 11. The patient took part in other new drug clinical trials in recent 3 months.

Design outcomes

Primary

Measure	Time frame
variation of ulcer area and volume;	—

Secondary

Measure	Time frame
Blood and urine routine examination, blood glucose;	—

Countries

China

Contacts

Public ContactRan Xingwu

ranxingwu@yahoo.com.cn+86 028 81812305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026