Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280053
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Brief Title:
HealiAid in the Treatment of Different Wounds
Sponsor:
Maxigen Biotech Inc
Organization:
Maxigen Biotech Inc
Study Overview
Official Title:
The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The goal of this open-label post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds venous ulcers bedsores diabetic foot wounds and burn wounds
The main questions it aims to answer are
1 The wound healing which was defined as the percentage of area change
2 The duration of wound healing
3 The granulation tissue growth of the wound
4 The wound exudate
5 Safety Indicators of which incidences after treatment
HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks
The main questions it aims to answer are
1 The wound healing which was defined as the percentage of area change
2 The duration of wound healing
3 The granulation tissue growth of the wound
4 The wound exudate
5 Safety Indicators of which incidences after treatment
HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks
Detailed Description:
An open-label study will be performed in single center to monitor about 6 patients in each types of wounds venous ulcers bedsores diabetic foot wounds and burn wounds totally 24 patients after the treatment of using HealiAid Collagen Wound Dressing MAXIGEN BIOTECH INC Taiwan directly on the wound sites
Follow-up visits will be at 1 2 4 8 and 12if needed weeks after the treatment
The primary endpoint of this study was the area percentage of healed wound at the 8-week post-treatment interval which is also considered as the healing condition of the wound
The secondary endpoints of this study were included the duration of wound healing granulation tissue growth wound exudate and the incidence of safety events
T-test or Wilcoxon rank-sum test will be used to test for the differences between baseline and each visit Statistical significance was established at p 005
The actual enrollment of this study was 6 participants each in the venous ulcers bedsores and burn wounds while no patients with diabetic foot wounds were recruited resulting in a total of 18 participants
Follow-up visits will be at 1 2 4 8 and 12if needed weeks after the treatment
The primary endpoint of this study was the area percentage of healed wound at the 8-week post-treatment interval which is also considered as the healing condition of the wound
The secondary endpoints of this study were included the duration of wound healing granulation tissue growth wound exudate and the incidence of safety events
T-test or Wilcoxon rank-sum test will be used to test for the differences between baseline and each visit Statistical significance was established at p 005
The actual enrollment of this study was 6 participants each in the venous ulcers bedsores and burn wounds while no patients with diabetic foot wounds were recruited resulting in a total of 18 participants
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?:
False
Is an FDA AA801 Violation?:
None