NCT06492811

Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds

A Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: The First Affiliated Hospital of University of South China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Wound

Interventions

Type	Name	Description
DRUG	GAT@F nanoenzyme hydrogel complex	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-02-01
• Completion: 2025-04-01
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: China