HealiAid in the Treatment of Different Wounds
NCT06280053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-02-28
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.
Conditions
- Venous Ulcers
- Bedsores
- Diabetic Foot Wound
- Burn Wound
Interventions
- DEVICE
-
HealiAid Collagen Wound Dressing
HealiAid is an absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix, in which the collagen is purified from bovine Achilles tendons. HealiAid can be applied easily by covering directly to the clean wound sites.
Sponsors & Collaborators
-
Maxigen Biotech Inc.
lead INDUSTRY
Principal Investigators
-
Huang-Kai Kao, Doctor · Chang Gung Memorial Hospital
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-02
- Primary Completion
- 2018-04-11
- Completion
- 2018-10-26
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