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

NCT06253975 | Recruiting

• 1 other identifier: Drkailiu-RCT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AT-EV group

EXPERIMENTAL

Biological: adipose tissue derived extracellular vesicles (AT-EVs)

HA group

PLACEBO COMPARATOR

Drug: Hyaluronic acid

Interventions

adipose tissue derived extracellular vesicles (AT-EVs) BIOLOGICAL

Extracellular vesicles from patient's adipose tissue together with HA

AT-EV group

Hyaluronic acid DRUG

Use HA only as a placebo

HA group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• If the wound is post-amputation, the time from surgery must be \>30 days;
• 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%

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai 9th People's Hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Kai Liu, M.D., Ph.D.

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  STUDY DIRECTOR

Central Study Contacts

Kai Liu, M.D., Ph.D.

CONTACT

+86 13501909852; drkailiu@126.com

Chuqiao Pan, M.D.

CONTACT

chuqiao04@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 12, 2024
• Study Start: February 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)