Wound HealNCT06253975
Randomized, Controlled, Multicenter Study of Extracellular Vesicles From Human Adipose Tissue Promoting Wound Healing
A study testing adipose tissue derived extracellular vesicles (AT-EVs) and Hyaluronic acid in people with Wound Heal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- adipose tissue derived extracellular vesicles (AT-EVs) and Hyaluronic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chuqiao Pan, M.D. contact
China1 site, 1 recruiting
- Recruiting
Shanghai 9th People's Hospital
Shanghai, Shanghai Municipality, 200011
Kai Liu, M.D., Ph.D., +86 13501909852, drkailiu@126.com
Chuqiao Pan, M.D., chuqiao04@hotmail.com
About this study
Official title: A Randomized, Controlled, Multicenter Study of Human Adipose Tissue Derived Extracellular Vesicles Promoting Wound Healing
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
- Being tested
- adipose tissue derived extracellular vesicles (AT-EVs), Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissue derived extracellular vesicles (AT-EVs)Biological
Extracellular vesicles from patient's adipose tissue together with HA
Hyaluronic acidDrug
Use HA only as a placebo
| Study group | Role | What they receive |
|---|---|---|
| AT-EV group | Experimental | Not described Receives: Biological: adipose tissue derived extracellular vesicles (AT-EVs) |
| HA group | Placebo comparator | Not described Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Liu, M.D., Ph.D., Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253975
- Sponsor's protocol ID
- Drkailiu-RCT
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Study of Human Adipose Tissue Derived Extracellular Vesicles Promoting Wound Healing
- ClinicalTrials.gov ID
- NCT06253975
- Acronym / sponsor ID
- Drkailiu-RCT
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT-EV group | Experimental | Biological: adipose tissue derived extracellular vesicles (AT-EVs) |
| HA group | Placebo comparator | Drug: Hyaluronic acid |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose tissue derived extracellular vesicles (AT-EVs)Extracellular vesicles from patient's adipose tissue together with HA | Biological | AT-EV group |
| Hyaluronic acidUse HA only as a placebo | Drug | HA group |
Primary outcome
The percentage of wound healing in each group at 10 weeks
Time frame: 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%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuqiao Pan, M.D. contact
Kai Liu, M.D., Ph.D. study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adipose tissue derived extracellular vesicles (AT-EVs) and Hyaluronic acid in people with Wound Heal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Liu, M.D., Ph.D. (+86 13501909852, drkailiu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of wound healing in each group at 10 weeks (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.