HealiAid in the Treatment of Different Wounds

NCT ID: NCT06280053

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2018-10-26

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.

Conditions

Venous Ulcers; Bedsores; Diabetic Foot Wound; Burn Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HealiAid group

The patients' wound conditions were divided into three types: venous ulcers, bedsores and burn wounds.

Group Type: EXPERIMENTAL

HealiAid Collagen Wound Dressing

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxigen Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huang-Kai Kao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Other Identifiers

103-3024A3

Identifier Type: -

Identifier Source: org_study_id