Wound HealingNCT04040933
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
A study testing Marketed Adhesive Bandage #1, Marketed Bandage #2 and Non-Marketed Bandage #1 in people with Wound Healing, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Marketed Adhesive Bandage #1, Marketed Bandage #2 and Non-Marketed Bandage #1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fitzpatrick Skin Type II or III
- Uniform skin color on both volar forearms
- Generally in good health based on medical history reported by the participant
- -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
- Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms
Who cannot join
- Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
- Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
- Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
- Has excessive hair or tattoos on either volar forearm
- Has a known history of severe systemic immune system disorders
- Has self-reported Type 1 or Type 2 diabetes
Show all 13Show fewer
- Has self-reported uncontrolled chronic diseases
- Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process
- Is self-reported to be pregnant or planning to become pregnant
- Has a body mass index (BMI) above 35
- Is self-reported to be an alcohol or drug abuser
- Has participated in another clinical trial within 10 days
- Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
- Conditions
- Wound Healing
- Being tested
- Marketed Adhesive Bandage #1, Marketed Bandage #2, Non-Marketed Bandage #1, Non-Marketed Bandage #2, Non-Marketed Adhesive Bandage #3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Adhesive Bandage #1Device
On the randomized wound site, a marketed adhesive bandage will be applied.
Marketed Bandage #2Device
On the randomized wound site, a marketed adhesive bandage will be applied.
Non-Marketed Bandage #1Device
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Non-Marketed Bandage #2Device
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Non-Marketed Adhesive Bandage #3Device
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Non-Marketed Adhesive Bandage #4Device
On the randomized wound site, a non-marketed adhesive bandage will be applied.
Non-Marketed Adhesive Bandage #5Device
On the randomized wound site, a non-marketed adhesive bandage will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Marketed Adhesive Bandage #1 | Active comparator | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Marketed Adhesive Bandage #1 |
| Marketed Adhesive Bandage #2 | Active comparator | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed only on Days 3, 5, 7, 9, 11, 13, 15, and 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Marketed Bandage #2 |
| Non-marketed Adhesive Bandage #1 | Active comparator | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Non-Marketed Bandage #1 |
| Non-marketed Adhesive Bandage #2 | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Non-Marketed Bandage #2 |
| Non-marketed Adhesive Bandage #3 | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Non-Marketed Adhesive Bandage #3 |
| Non-marketed Adhesive Bandage #4 | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Non-Marketed Adhesive Bandage #4 |
| Non-marketed Adhesive Bandage #5 | Experimental | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. Receives: Device: Non-Marketed Adhesive Bandage #5 |
| No Treatment (Uncovered, Negative Control) | No intervention | Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as negative control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Wound Healing
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 [Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing] to 4 [Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present])+smoothness (0 [Rough, uneven wound]- 4 [complete smoothness, even wound])+epithelial confluence (0 [None]- 4 [91-100%full epithelial growth]) - erythema (0 [None]- 4 [Severe]) - edema (0 [None]- 4 [Severe]) - crusting/scabbing (0 [None]- 4 [90-100% crusting/scabbing]). CHS on 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
Measured: Up to Day 16
Secondary outcomes (9)
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Change from Baseline in TEWL was reported. TEWL is the passive transfer of water through stratum corneum and was measured for each wound site using Tewameter TM330T. TEWL is a non-invasive method to measure the integrity of stratum corneum barrier function. Tewameter probe measures the density gradient of the water evaporation from the skin indirectly by two pairs of sensors (temperature and relative humidity) inside a hollow cylinder. The probe was held in place on the skin for one measurement, for 40 sec, to ensure that a stable value has been established. The values of the last 10 sec are averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Measured: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Change from baseline in Clinical grading of wound healing parameter (erythema) was evaluated on a scale of 0 (no erythema) to 4 (severe erythema).
Measured: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Change from baseline in Clinical grading of wound healing parameter (edema) was evaluated on a scale of 0 (no edema) to 4 (severe edema).
Measured: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Composite Scar Score
Change from baseline in composite scar score was reported. It was calculated as the sum of the individual parameters on the Manchester Scar Scale (Color ranges 1 [perfect] to 4 [gross mismatch]), Finish ranges 1 [matte] to 2 [shiny], Contour ranges 1 [Flush with surrounding skin] to 4 [keloid], Distortion ranges 1 [none] to 4 [severe] and Texture ranges 1 [normal] to 4 [hard]). Composite Scar Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing clinically worst scars.
Measured: Baseline and Day 28
Change From Baseline in Painful Score With Arm Resting by Side
Change from baseline in painful score based on participants self-assessment questionnaire score (question 1) was reported. Participants were asked to rate each wound for pain/soreness in resting position as score from 0 (no pain) to 10 (severe pain).
Measured: Baseline, Day 1, 2, 3 and 4
Change From Baseline in Painful Score With Arm in Normal Motion
Change from baseline in Painful Score based on participants self-assessment questionnaire score (question 3) was reported. Participants were asked to rate each wound for pain/soreness in normal position as score from 0 (no pain) to 10 (severe pain).
Measured: Baseline, Day 1, 2, 3 and 4
Change From Baseline in Itchy Score
Change from baseline in itchy score based on participants self-assessment questionnaire score (question 5) was reported. Participants were asked to rate each wound for itchiness as score from 0 (no itch) to 10 (severe itch).
Measured: Baseline, Day 1, 2, 3 and 4
Number of Participants With Pain Duration With Arm Resting by Side
Participants were asked to rate the pain as either brief, periodic, or constant in arm resting position with the Self-Assessment Questionnaire (question 2). Number of participants with pain duration (brief, periodic, or constant) with arm resting by side was reported.
Measured: Day 1, 2, 3 and 4
Number of Participants With Pain Duration With Arm in Normal Motion
Participants were asked to rate the pain as either brief, periodic, or constant in arm normal motion with the Self-Assessment Questionnaire (question 4). Number of participants with pain duration (brief, periodic, or constant) with arm in normal motion was reported.
Measured: Day 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start9 Aug 2019
- Primary completion18 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lily Jiang, PhD, Principal investigator, Thomas J. Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040933
- Sponsor's protocol ID
- CCSTOH001689
- Other IDs
- CCSTOH001689
- Status last verified
- Jun 2023
- First submitted
- 30 Jul 2019
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
- ClinicalTrials.gov ID
- NCT04040933
- Acronym / sponsor ID
- CCSTOH001689
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Marketed Adhesive Bandage #1 | Active comparator | Device: Marketed Adhesive Bandage #1Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Marketed Adhesive Bandage #2 | Active comparator | Device: Marketed Bandage #2Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed only on Days 3, 5, 7, 9, 11, 13, 15, and 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Non-marketed Adhesive Bandage #1 | Active comparator | Device: Non-Marketed Bandage #1Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Non-marketed Adhesive Bandage #2 | Experimental | Device: Non-Marketed Bandage #2Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Non-marketed Adhesive Bandage #3 | Experimental | Device: Non-Marketed Adhesive Bandage #3Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Non-marketed Adhesive Bandage #4 | Experimental | Device: Non-Marketed Adhesive Bandage #4Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| Non-marketed Adhesive Bandage #5 | Experimental | Device: Non-Marketed Adhesive Bandage #5Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, bandage will be applied. This adhesive bandage will be changed daily from Day 1 through Day 16 and all wound sites will be uncovered from Day 16 to Day 28 for assessments. |
| No Treatment (Uncovered, Negative Control) | No intervention | –Minor wounds will be created on participant's forearms (four per arm) by a certified laser specialist. On the randomized wound site, no treatment will be applied as the wound will be kept uncovered as negative control. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fitzpatrick Skin Type II or III
- Uniform skin color on both volar forearms
- Generally in good health based on medical history reported by the participant
- -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
- Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms
Key exclusion criteria (13 listed)
- Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
- Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
- Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
- Has excessive hair or tattoos on either volar forearm
- Has a known history of severe systemic immune system disorders
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 |
|---|---|---|
| Marketed Adhesive Bandage #1On the randomized wound site, a marketed adhesive bandage will be applied. | Device | Marketed Adhesive Bandage #1 |
| Marketed Bandage #2On the randomized wound site, a marketed adhesive bandage will be applied. | Device | Marketed Adhesive Bandage #2 |
| Non-Marketed Bandage #1On the randomized wound site, a non-marketed adhesive bandage will be applied. | Device | Non-marketed Adhesive Bandage #1 |
| Non-Marketed Bandage #2On the randomized wound site, a non-marketed adhesive bandage will be applied. | Device | Non-marketed Adhesive Bandage #2 |
| Non-Marketed Adhesive Bandage #3On the randomized wound site, a non-marketed adhesive bandage will be applied. | Device | Non-marketed Adhesive Bandage #3 |
| Non-Marketed Adhesive Bandage #4On the randomized wound site, a non-marketed adhesive bandage will be applied. | Device | Non-marketed Adhesive Bandage #4 |
| Non-Marketed Adhesive Bandage #5On the randomized wound site, a non-marketed adhesive bandage will be applied. | Device | Non-marketed Adhesive Bandage #5 |
Primary outcome
Time to Complete Wound Healing
Time frame: Up to Day 16
Time to complete wound healing: time(in days) elapsed from time of wound creation to 12 PM of day (up to Day 16) on which composite healing score(CHS) first meets complete healing criterion of being at least a score of 8 (threshold for complete healing). CHS was calculated from clinical grading of wound healing parameters as general wound appearance (0 [Poor-New or fresh wound with epithelium layer missing, wound bed appears raw and possibly oozing] to 4 [Excellent-Fully healed, skin flush against surrounding skin, slight color mismatch may be present])+smoothness (0 [Rough, uneven wound]- 4 [complete smoothness, even wound])+epithelial confluence (0 [None]- 4 [91-100%full epithelial growth]) - erythema (0 [None]- 4 [Severe]) - edema (0 [None]- 4 [Severe]) - crusting/scabbing (0 [None]- 4 [90-100% crusting/scabbing]). CHS on 25-point scale (-12 [no healing] to +12 [towards healing]) is indicative of extent of wound healing and was calculated for each wound site at each evaluation day.
9 secondary outcomes
Change From Baseline in Trans-Epidermal Water Loss (TEWL) Measurements
Time frame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Change From Baseline in Clinical Grading of Wound Healing Parameter - Erythema
Time frame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Clinical Grading of Wound Healing Parameter - Edema
Time frame: Day 0 (immediate after wound creation), Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
Change From Baseline in Composite Scar Score
Time frame: Baseline and Day 28
Change From Baseline in Painful Score With Arm Resting by Side
Time frame: Baseline, Day 1, 2, 3 and 4
Change From Baseline in Painful Score With Arm in Normal Motion
Time frame: Baseline, Day 1, 2, 3 and 4
Change From Baseline in Itchy Score
Time frame: Baseline, Day 1, 2, 3 and 4
Number of Participants With Pain Duration With Arm Resting by Side
Time frame: Day 1, 2, 3 and 4
Number of Participants With Pain Duration With Arm in Normal Motion
Time frame: Day 1, 2, 3 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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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.
Lily Jiang, PhD principal investigator
Thomas J. Stephens & Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed Adhesive Bandage #1, Marketed Bandage #2 and Non-Marketed Bandage #1 in people with Wound Healing, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
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 5 inclusion and 13 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Complete Wound Healing (time frame: Up to Day 16). 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 3 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.