Venous UlcersNCT06280053
HealiAid in the Treatment of Different Wounds
A study testing HealiAid Collagen Wound Dressing in people with Venous Ulcers and Bedsores, run by Maxigen Biotech Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcers, Bedsores, Diabetic Foot Wound
- What is being tested?
- HealiAid Collagen Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 26 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant or lactating women.
- It is known that there has been a previous allergic reaction to any component of the dressing.
- Allergic to collagen.
About this study
Official title: The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds
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:
- The wound healing which was defined as the percentage of area change.
- The duration of wound healing.
- The granulation tissue growth of the wound.
- The wound exudate.
- Safety Indicators of which incidences after treatment.
HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks.
Read the 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
- Being tested
- HealiAid Collagen Wound Dressing
- Keywords
- Collagen Wound Dressing, Post-marketing Study
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealiAid Collagen Wound DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HealiAid group | Experimental | The patients' wound conditions were divided into three types: venous ulcers, bedsores and burn wounds. Receives: Device: HealiAid Collagen Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline, 8 weeks after treatment
Secondary outcomes (5)
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%.
Measured: 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.
Measured: 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.
- 0: the wound site is either completely healed or shallow.
- 1: the granulation tissue occupied 90% of wound area
- 2: the granulation tissue occupied ≥50%, <90% of wound area
- 3: the granulation tissue occupied ≥10%, <50% of wound area
- 4: the granulation tissue occupied <10% of wound area
- 5: No granulation tissue present
Measured: Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment
Wound Exudate
The extent of wound exudate was classified as 4 grades.
- 0: No wound exudate
- 1: Small amount of wound exudate, may not require daily dressing changes
- 2: Moderate amount of wound exudate, requires daily dressing changes
- 3: Large amount of wound exudate, dressing changes at least twice daily
Measured: 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:
- 0: No signs of infection or inflammation.
- 1: Redness, swelling, heat, and pain that indicated inflammation.
- 2: Clear signs of infection such as inflammation, purulence, or odor.
- 3: Systemic symptoms such as fever.
Other safety events such as allergic reaction was scored as:
- 0: No reaction
- 1: Doubtful reaction
- 2: Weak reaction
- 3: Strong reaction
Measured: week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start2 Mar 2016
- Primary completion11 Apr 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huang-Kai Kao, Doctor, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280053
- Sponsor's protocol ID
- 103-3024A3
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds
- ClinicalTrials.gov ID
- NCT06280053
- Acronym / sponsor ID
- 103-3024A3
- Conditions
- Venous Ulcers, Bedsores, Diabetic Foot Wound, Burn Wound
- Keywords
- Collagen Wound Dressing, Post-marketing Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The wound healing which was defined as the percentage of area change.
- The duration of wound healing.
- The granulation tissue growth of the wound.
- The wound exudate.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients' wound conditions were divided into four types: venous ulcers, bedsores, diabetic foot wounds and burn wounds.
| Arm | Type | Receives |
|---|---|---|
| HealiAid group | Experimental | Device: HealiAid Collagen Wound DressingThe patients' wound conditions were divided into three types: venous ulcers, bedsores and burn wounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealiAid Collagen Wound DressingHealiAid 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. | Device | HealiAid group |
Primary outcome
Wound Healing
Time frame: Baseline, 8 weeks after treatment
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%.
5 secondary outcomes
Wound Healing
Time frame: Baseline, 1, 2, 4, 12(if needed) weeks after treatment
Duration of Wound Healing
Time frame: Baseline, 1, 2, 4, 12(if needed) weeks after treatment
Granulation Tissue Growth
Time frame: Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment
Wound Exudate
Time frame: Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment
Incidence of Safety Events
Time frame: week 0 to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang-Kai Kao, Doctor principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing HealiAid Collagen Wound Dressing in people with Venous Ulcers and Bedsores, run by Maxigen Biotech Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: Baseline, 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.