Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
NCT Number: NCT06492811
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Wound
Interventions: DRUG: GAT@F nanoenzyme hydrogel complex
Sponsor: The First Affiliated Hospital of University of South China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 49
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2025-04-01
Locations: The First Affiliated Hospital of University of South China, Hengyang, Hunan, China

Summary:
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.

Primary Outcome Measures: Granulation coverage, Wound granulation tissue coverage (%) = (granulation coverage area)/(total wound area) ×100%, 14 days
Secondary Outcome Measures: Wound healing rate, Wound healing rate (%) = (original wound area - current wound area)/(original wound area) ×100%, 14 days|Wagner rating Scale, 14 days|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