Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492811
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Efficacy and Safety of a Hydrogel Containing Cascade Catalytic Enzymes in the Treatment of Diabetic Wounds
Sponsor:
The First Affiliated Hospital of University of South China
Organization:
The First Affiliated Hospital of University of South China
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studyThis clinical study is expected to include 49 participants and treat patients with diabetic woundsEach 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 1GATF nanoenzyme hydrogel complex dressing2Medical chitosan bio-gel dressing 3Blank hydrogel dressing
Diabetic wounds were treated with experimental dressing and dressing was changed once a day for 14 consecutive daysNeither subjects nor investigators were informed of the treatment assignmentDuring treatment the granulation coverage rate and wound healing rate of each group were evaluated at the second visit the third visit and the fourth visitWounds were scored using Wagner grading scale Wlfl grading scale and IDSAIWGDF grading scaleThe 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 evaluatedThe 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 visitThe safety follow-up was conducted by telephone on the 30th and 60th day after the last treatment to collect safety information
Successfully enrolled subjects will be randomly divided into one of the following treatment groups 1GATF nanoenzyme hydrogel complex dressing2Medical chitosan bio-gel dressing 3Blank hydrogel dressing
Diabetic wounds were treated with experimental dressing and dressing was changed once a day for 14 consecutive daysNeither subjects nor investigators were informed of the treatment assignmentDuring treatment the granulation coverage rate and wound healing rate of each group were evaluated at the second visit the third visit and the fourth visitWounds were scored using Wagner grading scale Wlfl grading scale and IDSAIWGDF grading scaleThe 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 evaluatedThe 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 visitThe safety follow-up was conducted by telephone on the 30th and 60th day after the last treatment to collect safety information
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None