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A randomized, open label, parallel-controlled trial of the efficacy and safety of autologous nano-fat combined with platelet-rich fibrin in the treatment of refractory wounds of diabetic foot

A randomized, open label, parallel-controlled trial of the efficacy and safety of autologous nano-fat combined with platelet-rich fibrin in the treatment of refractory wounds of diabetic foot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013540
Enrollment
Unknown
Registered
2017-11-25
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

Diabetic foot chronic wound

Interventions

Control:Palliative debridement
Experimental group:Wound dressing change

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. 1-2 Wagner grade of diabetic foot; 3. with ulcers for at least 4 weeks or above; 4. The area of skin defect after debridement range from 1 to 20cm2; 5. The subject or his legal agent understands the purpose and the necessary procedures of this study, and is willing to participate in this study with the signature of the informed consent form.

Exclusion criteria

Exclusion criteria: 1. ulcers caused by scalds, burns, and radioactive damage; 2. ulcers caused by varicose veins; 3. Malignant lesions in foot ulcers; 4. Ankle brachial index (ABI) 1.3; 5. Diabetic foot Wagner grade 0, grade 3 and above; 6. Patients with serious disease in the system of heart, liver, lung, kidney or blood, or with acute attack of chronic disease, or with fasting blood-glucose = 10mmol/L, or with blood pressure > 140/90mmHg, or with hemoglobin 300×10^9/L, or with coagulation abnormalities, or with abnormal cardiac function, or with abnormal liver function, or with abnormal renal function, or with malnutrition; 7.Patients have received glucocorticoids, drugs that affect platelet function, immunosuppressor, radiotherapy or chemotherapy within 3 months, or need to receive with the aforementioned treatment during the study period; 8. Patients with mental disorders or cancers; 9. Pregnant or lactating women; 10. Patients have participated in other clinical trials within three months; 11. Patients are regarded as be ineligible for the participation in this research by the researchers.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Secondary

MeasureTime frame
The infection rate;Amputation (toe) rate;

Countries

China

Contacts

Public ContactZhang Peihua

Affiliated Hospital of Guangdong Medical University

zhangph1128@126.com+86 13553510943

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026