Clinical trial NCT06280053: HealiAid in the Treatment of Different Wounds
Official title: The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcers
Bedsores
Diabetic Foot Wound
Burn Wound
Keywords: Collagen Wound Dressing
Post-marketing Study
Lead sponsor: Maxigen Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.
Primary purpose: OTHER

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with wounds.
* The venous ulcer has been present for at least 30 days without healing, graded as stage 3, and the wound is at least 1 cm\^2 (maximum length x maximum width).
* Diabetic foot wound is classified as Wagner grade 2, and the wound is at least 1cm\^2 (maximum length × maximum width).
* Bedsore (NPUAP) is graded as level 2, and the wound is at least 1cm\^2 (Maximum length × maximum width).
* Burn wound is classified as grade 2, and the wound is at least 1cm\^2 (maximum length × maximum width).
* The limbs of patients with venous ulcers and diabetes are assessed using Doppler to measure blood circulation, confirming adequate blood flow in the affected tissues.
* After a complete debridement operation, confirm that there is no necrotic or viable lesion tissue.

Exclusion Criteria:

* There is an inflammatory response clinically.
* A wound site with bone exposure.
* Existing conditions or diseases may affect wound healing(e.g., cancer, vasculitis, connective tissue disorders, or any immune system disorders).
* Alcohol abuse.
* Within the past 30 days prior to enrollment, any use of medications that may affect wound healing, such as those associated with dialysis, steroids, immunosuppressants, radiation therapy, or chemotherapy.
* There are multiple ulcer wounds present on the same limb affected by the lesion.
* Pregnant or lactating women.
* It is known that there has been a previous allergic reaction to any component of the dressing.
* Allergic to collagen.

Primary outcomes:
measure: Wound Healing
timeFrame: Baseline, 8 weeks after treatment
Secondary outcomes:
measure: Wound Healing
timeFrame: Baseline, 1, 2, 4, 12(if needed) weeks after treatment
measure: Duration of Wound Healing
timeFrame: Baseline, 1, 2, 4, 12(if needed) weeks after treatment
measure: Granulation Tissue Growth
timeFrame: Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment
measure: Wound Exudate
timeFrame: Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment
measure: Incidence of Safety Events
timeFrame: week 0 to week 12
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Huang-Kai Kao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: