lower limbs hard-to-heal wound
Conditions
Interventions
nano fat treated group:nano fat treated
Decellularized adipose extracellular matrix treated group:Decellularized adipose extracellular matrix treated
Sponsors
The first affiliated hospital of Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The age is greater than or equal to 18 years old, regardless of gender 2. The chronic refractory wound of lower extremity was clinically diagnosed, and the wound was located below the thigh. Patients with no obvious tendency of wound healing who received standard treatments such as etiological treatment, wet dressing change, and necessary decompression for more than 2 weeks. (Explained in detail in the treatment protocol) 3. The patients understood the requirement of the experiment, were willing to participate and cooperate with the experimental treatment , and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Lower limb edema caused by cardiac insufficiency; 2. Patients with lower extremity venous thrombosis ; 3. diabetic patients with poor glycemic control; Fasting blood glucose >=8mmol/L; Or 2h postprandial blood glucose >=10.0mmol/L; Or glycosylated hemoglobin (HbA1c) range >= 9%; 4. Have participated in similar clinical trials within the past three months; 5. Patients with lower extremity arterial occlusion requiring lower extremity vascular surgery; 6. Patients with wound infection requiring systemic antibiotic treatment; 7. Patients with dry crust or necrotic tissue covering more than 50% of the wound surface and unsuitable for or refusing to receive debridement treatment; 8. Immunocompromised patients; 9. Patients with the possibility of wound malignant transformation or with malignant lesions (chronic wounds that has lasted more than 1 year should be excluded by biopsy ); 10. Patients with wound area greater than 100 cm2; 11. Deep bone, joint cavity, body cavity wound; 12. Wounds with sinus tract; 13. Patients with severe organ dysfunction and severe malnutrition; 14. Patients with psychiatric or other problems who are unable to self-manage the device; 15. Treat patients with poor compliance. 16. Those who were deemed by the investigator to be unfit to participate in the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| satisfaction of patients and researchers;Oxygen concentration of the skin around the wound;VAS score of pain;composition determination of secretion;The formation of bacterial biofilm ; | — |
Countries
China
Contacts
Public ContactHongwei Liu
The first affiliated hospital of Jinan University
Outcome results
None listed