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This clinical study is a prospective, randomized, double-blind, positive-controlled, parallel study. Subjects who sign study informed consent (ICF) approved by Ethics Committee (EC) and meet all of the inclusion criteria and none of the exclusion criteria are eligible to enter the study.This clinical study is expected to include 49 participants and treat patients with diabetic wounds.Each participant is expected to participate for about 3 months, including a 2-week screening period, a 2-week dressing period, and an 8-week safety follow-up period.
Successfully enrolled subjects will be randomly divided into one of the following treatment groups: (1)GAT@F nanoenzyme hydrogel complex dressing(2)Medical chitosan bio-gel dressing (3)Blank hydrogel dressing.
Diabetic wounds were treated with experimental dressing, and dressing was changed once a day for 14 consecutive days.Neither subjects nor investigators were informed of the treatment assignment.During treatment, the granulation coverage rate and wound healing rate of each group were evaluated at the second visit, the third visit and the fourth visit.Wounds were scored using Wagner grading scale, Wlfl grading scale and IDSA/IWGDF grading scale.The histological morphology, ROS, sugar content, IL-6 and TNF-α of the wound were quantitatively detected at the second and fifth visits, and the changes of the data results compared with baseline were evaluated.The tolerability (occurrence of local adverse events) and acceptability (ease of application and removal, adherence of the dressing to the wound bed, bleeding or pain during dressing removal) of the dressing were qualitatively assessed and recorded at the 2nd visit, 3rd visit, and 4th visit.The safety follow-up was conducted by telephone on the 30th and 60th day after the last treatment to collect safety information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAT@F nanoenzyme hydrogel complex | Experimental | The glucose oxidase (GOx) and catalase (CAT) cascade systems have been included in the therapeutic system of diabetic wounds,with GOx primarily consumes glucose to create H2O2, while CAT further catalyzes H2O2 to provide sufficient oxygen.Natural enzymes have excellent cascade catalytic efficiency as well as biocompatibility. Hydrogels have high water content and cargo loading efficiency, as well as superior biocompatibility, making them popular in wound healing applications. |
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| Medical chitosan bio-gel dressing | Active Comparator | The medical device database of the National Medical Products Administration (NMPA) was searched and the Medical chitosan bio-gel dressing (6S YinYu)(20182640080) was selected. The positive control product used in this trial is based on the following points:
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| Blank hydrogel dressing | Placebo Comparator | Hydrogel dressings can maintain a moist environment at the wound site, which promotes cell migration and tissue regeneration, thus accelerating the healing process. Hydrogels have excellent absorption capabilities, helping to manage wound exudate and reduce the risk of infection by forming a physical barrier against bacteria and contaminants. Moreover, hydrogels are biocompatible and unlikely to cause allergic reactions or rejection. Their softness and flexibility enable them to conform to irregular wound surfaces, providing effective coverage and protection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAT@F nanoenzyme hydrogel complex | Drug | The wound condition was recorded by taking photos each time the dressing was changed. The diabetic wound was routinely treated with a dressing change, after which GAT@F nanoenzyme hydrogel complex was applied externally and a secondary dressing - medical surgical gauze was added. According to existing clinical data, it is recommended to use no more than 10ml per dressing change. |
| Measure | Description | Time Frame |
|---|---|---|
| Granulation coverage | Wound granulation tissue coverage (%) = (granulation coverage area)/(total wound area) ×100% | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate | Wound healing rate (%) = (original wound area - current wound area)/(original wound area) ×100% | 14 days |
| Wagner rating Scale | 14 days |
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Inclusion Criteria:
Subjects who voluntarily participate in this clinical study and sign informed consent;
Subjects aged 18-80 years (including boundary values), male or female;
Participants must meet the following criteria to participate in the study:
Female subjects:
Male subjects:
Exclusion Criteria:
Participants in this clinical trial will not be enrolled if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | China |
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| Wlfl rating Scale | 14 days |
| IDSA/IWGDF rating scale score | 14 days |
| Histopathological analysis score | 14 days |
| ROS quantitative detection value of wound tissue | 14 days |
| Quantitative measurement of sugar content in wound tissue | 14 days |
| Quantitative detection of IL-6 and TNF-α in wound tissue | 14 days |