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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-EV group | Experimental |
| |
| HA group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adipose tissue derived extracellular vesicles (AT-EVs) | Biological | Extracellular vesicles from patient's adipose tissue together with HA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Liu, M.D., Ph.D. | Contact | +86 13501909852 | drkailiu@126.com | |
| Chuqiao Pan, M.D. | Contact | chuqiao04@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kai Liu, M.D., Ph.D. | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 9th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| Hyaluronic acid | Drug | Use HA only as a placebo |
|
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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