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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:
HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks.
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 12(if 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 < 0.05.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HealiAid group | Experimental | The patients' wound conditions were divided into three types: venous ulcers, bedsores and burn wounds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealiAid Collagen Wound Dressing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | The wound healing was defined as the percentage of area change at baseline and 8 weeks after treatment. The wound area was calculated by multiplying the length (direction from head to leg) by the width (widest part of the wound site, perpendicular to the length). The percentage of area change was calculated by the formula: (baseline wound area minus 8-week wound area)/baseline wound area *100%. | Baseline, 8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | The wound healing was defined as the percentage of area change at baseline and 1, 2, 4 weeks after treatment. The wound area was calculated by multiplying the length (direction from head to leg) by the width (widest part of the wound site, perpendicular to the length). The percentage of area change was calculated by the formula: (baseline wound area minus 1, 2 or 4-week wound area)/baseline wound area *100%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huang-Kai Kao, Doctor | Chang Gung Memorial Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| D002056 | Burns |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.
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| Baseline, 1, 2, 4, 12(if needed) weeks after treatment |
| Duration of Wound Healing | The duration of wound healing was recorded using the subjects' diaries, which indicated the time when the wound completely healed. | Baseline, 1, 2, 4, 12(if needed) weeks after treatment |
| Granulation Tissue Growth | The granulation tissue growth was defined using a scale of 6 grades.
| Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment |
| Wound Exudate | The extent of wound exudate was classified as 4 grades.
| Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment |
| Incidence of Safety Events | The safety events were defined as the wound site infection/inflammation and scoring as:
Other safety events such as allergic reaction was scored as:
| week 0 to week 12 |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |