Randomized, Controlled, Multicenter Study of Extracellular Vesicles From Human Adipose Tissue Promoting Wound Healing

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Feb 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether special tiny particles called extracellular vesicles from human fat tissue can help heal difficult-to-treat wounds. Researchers are comparing the effects of these vesicles to a placebo, which is a treatment that does not contain any active ingredients, to see if they can promote better healing in people with chronic wounds. The study is currently looking for participants aged 18 to 69 who have full-thickness skin ulcers that have lasted between 4 weeks to 1 year. To qualify, participants must also meet specific health criteria, such as having a certain level of blood flow to the area and not having infections or other serious conditions.

If you decide to join this trial, you can expect to receive either the vesicle treatment or a placebo, and you will be monitored closely throughout the study to track your wound healing progress. It's important to note that certain individuals, such as those with infections or severe health issues, may not be eligible to participate. This trial aims to find new ways to improve wound healing, which could ultimately help many people who struggle with these types of injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 69 years old, regardless of gender 2. Full-layer skin ulcers on various parts of the body, lasting from 4 weeks to 1 year
• • 1. If the wound is post-amputation, the time from surgery must be \>30 days;
• • 2. If there is \>1 wound surface, the maximum wound surface is selected as the research target; 3. At the beginning of the induction period, the wound size after debridement was ≥1 and ≤20 cm2; 4.Texas classification 1A, 1B, 1C, 1D, 2A, 2B, 2C or 2D; 5. Ankle-brachial index ≥0.7, including percutaneous oxygen pressure (TcPO2) ≥30 mm Hg and cutaneous perfusion pressure ≥30 mm Hg; 6. Revascularization procedures or vascular surgery that are not scheduled in the past or the next 30 days; 7. The subject and family members are willing and able to comply with all prescribed care and medical requirements; 8. The subject has a reasonable expectation of completing the study; 9. The subject completed the 2-week induction period and the wound was reduced by 30%
• Exclusion Criteria:
• • 1. The subject has signs of gangrene in any part of the trunk and limbs; 2. A written diagnosis of osteomyelitis in any part of the affected limb; 3. Bone tissue at the wound site of the subject is exposed; 4. Poor blood glucose control in subjects: HbA1c\>12% (108 mmol/mol); 5. Subjects are receiving renal dialysis treatment or creatinine \>2.5mg/dl (221mmol/L); 6. The subject has obvious immune deficiency; 7. The subject has suspected tumor or is receiving tumor treatment; 8. Subject has used steroids or immunosuppressants in the past 3 months or is expected to use them during the study; 9. Subjects received growth factor therapy, autologous platelet-rich plasma gel, double-layer cell therapy, dermal substitute, extracellular matrix, etc., during the screening period; 10. The subject has participated in another research device, drug, or biological trial within the past 30 days; 11. The wound shows serious clinical symptoms of infection, requiring hospitalization or immediate surgical treatment; 12. The subject has developed deep vein thrombosis within the past 30 days; 13. The subject is pregnant or breastfeeding; 14. The subject has serious mental illness and psychological disorder; 15. The subject was judged unfit for the test by the attending physician.