Chronic Wound
Conditions
Interventions
Treatment Group:AmGel
Control Group:Alginate wound dressing
Sponsors
Shanghai 9th People’s Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 85 years, inclusive, regardless of gender. 2. Patients with chronic wounds (wounds that have not healed after more than one month of standard treatment). 3. Wound area between 1 square centimeter and 100 square centimeters, inclusive. 4. Patients whose wound area has decreased by no more than 30% after 14 days of standard treatment and debridement. 5. Patients who agree to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with wounds extending to the muscle, tendon, or bone. 2. Patients with obvious wound infection or at high risk of infection. 3. Patients with severe ischemic ulcer wounds where the blood supply arteries have not been improved. 4. Patients with tumor-related wounds, radiation-induced skin ulcers, or iatrogenic wounds (where iatrogenic damage factors cannot be excluded). 5. Patients with wounds that have sinus tracts or fistulas. 6. Patients currently undergoing oxygen therapy, laser therapy, ultrasound therapy, or magnetic therapy for their wounds. 7. Patients who have received local growth factor treatment for their wounds within the last 30 days. 8. Diabetic patients with poorly controlled blood glucose levels. 9. Patients currently taking more than 7.5 mg of steroids per day or immunosuppressive agents. 10. Patients with known allergies or a tendency to form keloids. 11. Patients with other diseases that would make treatment and evaluation difficult. 12. Women who are known to be pregnant or breastfeeding, or those planning to become pregnant during the study period. 13. Patients who have participated in other drug or medical device clinical trials within the last 3 months. 14. Patients whom the investigator deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound Closure Rate;Wound Closure Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing rate;Wound healing time;The number of instruments used;Subject satisfaction evaluation;Instrument performance evaluation;Incidence of wound infection;Systemic/local reaction occurrence; Record changes in clinically relevant laboratory test values;Other adverse events or serious adverse events occurred; | — |
Countries
China
Contacts
Public ContactTing Xie
Shanghai 9th People’s Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed