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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06253975
Other study ID # Drkailiu-RCT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact Kai Liu, M.D., Ph.D.
Phone +86 13501909852
Email drkailiu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

By randomly assigning study subjects into groups, interventions with adipose tissue-derived extracellular vesicles (AT-EVs) and placebos are conducted to evaluate whether AT-EVs can promote effective healing of recalcitrant wounds.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
adipose tissue derived extracellular vesicles (AT-EVs)
Extracellular vesicles from patient's adipose tissue together with HA
Drug:
Hyaluronic acid
Use HA only as a placebo

Locations

Country Name City State
China Shanghai 9th People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of wound healing in each group at 10 weeks The percentage of wound healing in each group at 10 weeks was calculated as: (initial wound area - wound area at 10 weeks of treatment)/initial wound area ×100%. 10 weeks
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