HealiAid in the Treatment of Different Wounds

NCT06280053 | Completed

• 1 other identifier: 103-3024A3
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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. 1.The wound healing which was defined as the percentage of area change.
2. 2.The duration of wound healing.
3. 3.The granulation tissue growth of the wound.
4. 4.The wound exudate.
5. 5.Safety Indicators of which incidences after treatment.

Conditions

Venous Ulcers; Bedsores; Diabetic Foot Wound; Burn Wound

Keywords

Collagen Wound Dressing; Post-marketing Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Wound Healing

  Baseline, 1, 2, 4, 12(if needed) weeks after treatment

• Duration of Wound Healing

  Baseline, 1, 2, 4, 12(if needed) weeks after treatment

• Granulation Tissue Growth

  Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment

• Wound Exudate

  Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment

• Incidence of Safety Events

  week 0 to week 12

Study Arms (1)

HealiAid group

EXPERIMENTAL

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

Device: HealiAid Collagen Wound Dressing

Interventions

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.

HealiAid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer; Burns

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Huang-Kai Kao, Doctor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 2, 2016
• Primary Completion: April 11, 2018
• Study Completion: October 26, 2018
• Last Updated: February 28, 2024

Record last verified: 2024-02