Wound HealHERONCT07329114
Healing Electroceutical Dressing for the Recovery of Open Wounds (HERO)
A study testing PowerHeal™ Bioelectric Bandage in people with Wound Heal and Wound Infection, run by Chandan Sen at 1 site in Ukraine.
Trial summary
The goal of this clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better. The main hypotheses it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Wound Heal, Wound Infection, Wound Healing Delayed
- What is being tested?
- PowerHeal™ Bioelectric Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 11 Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male participants 18-105 years of age
- Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine
- At least one infected traumatic wound(s) between 20-40 cm2 in size. Probable or confirmed wound infection(s) will be determined by on-site physicians' clinical judgment and the presence of two or more of the following clinical indicators of wound infection:
- Presence of worsening pain (from the moment of injury)
- Erythema (redness)
- Warmth (heat)
Show all 16Show fewer
- Edema (swelling)
- Purulent exudate (drainage)
- Delayed healing
- Discoloration
- Friable granulation
- Foul odor
- Wound margin breakdown or necrosis with or without fever
- Pustules, vesicles, boils
- Participant or legal representative provides written informed consent prior to investigation procedures
- Participant understands and agrees to adhere to planned investigation procedures
Who cannot join
- Allergy to silver or zinc
- Women who are pregnant or nursing
- Women of childbearing potential without a documented negative pregnancy test during the current hospitalization or women of childbearing potential who refused pregnancy testing during screening
- Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the investigator, and their respective family members
- > 60 days from the initial traumatic injury
- Known prisoner
Show all 13Show fewer
- The patient is expected to be discharged from the hospital within the next 24 hours
- Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization
- Moribund condition, defined as life expectancy less than 48 hours from randomization
- Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life
- Expected inability or unwillingness to participate in study procedures
- In the opinion of the investigator, participation in the investigation is not in the best interest of the patient
- Note: Allergies to parabens and acrylates will also be considered. While they are not direct exclusions, participants with these allergies should avoid being enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Piya Das Ghatak, PhD, MS contact
Ukraine1 site, 1 recruiting
- Recruiting
Ivano-Frankivsk Central Clinical Hospital
Ivano-Frankivsk, 76000
Roman Fishchuk, MD MSc, +380504332119, fishchukroman@gmail.com
About this study
Official title: Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds
The goal of this clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better.
The main hypotheses it aims to answer are:
Read more
- WED promotes wound closure, as determined by wound area measurement
- WED manages wound infection in civilian and military wounds in Ukraine, as determined by clinical assessment of wound infection by measuring the numbers and types of relevant microbes.
Researchers will compare to see if PowerHeal™ Bioelectric Bandage the dressing used in the SOC group
Participants will get their dressings changed per the protocol, wound image and swab will be taken.
Read the detailed description
Managing bacterial burden is necessary for effective wound healing. Military wounds are severely complex due to rise in multidrug resistant bacterial infections. A FDA cleared commercially available disposable, wireless electroceutical dressing fabric is able to generate a low electric field in presence of exudate in the wound environment. The electric field, along with the micro-molar amounts of superoxide anion radicals that is generated in the wound microenvironment, initiate a bactericidal and a pro-healing signaling cascade resulting in improved wound healing without the encumbrance of a bulky dressing.
There will be five visits over the course of 28 ± 2 days. Participants will be randomized and divided into two groups: one group will receive the standard of care (SOC) dressing and the other will receive the bioelectric bandage. Dressing change intervals will depend on the group the participant randomized to and how exudating the wound is.
The investigation doctor will collect demographic data - such as, age, sex, race; general medical history, and targeted wound data -such as cause, size, location, duration and total number of traumatic wounds. Standard of care clinical lab results (complete blood count, liver and kidney functions, presence and level of inflammation) will also be collected to evaluate body functions and health status . No blood will be collected for this study.
Vital signs (body temperature, respiratory rate, heart rate, blood pressure, level of oxygen in blood) will be measured. The doctor will also look for signs of wound infection (of the investigation wound) including, redness, warmth, swelling, drainage, discoloration, friable granulation, foul odor, necrosis, and pustule/vesicles/boils. Participants will be asked about their pain experience compared to the moment of the injury.
A swab of the investigation wound will be collected per standard study guidelines at each investigation timepoint (unless the wound heals). A member of the study team will clean the wound using sterile sodium chloride solution, then gently rotate a sterile swab over a small area of the wound to collect a sample. All collected wound swabs will be sent to and processed in a central lab within Ukraine to check the infection status of the wound. Microbes detected in the wound will then be further analyzed in a separate central laboratory in the US to look at important factors such as antibiotic resistance. The results of the research wound swabs and analysis data will not be shared with the participant, or their medical care provider.
At each investigation timepoint, the investigation wound will also be photographed by the investigator or a member of the investigation team using the camera function on a standard smartphone to see if there is any change before and after receiving the treatment. The investigation wound will also be measured for size by holding a clear, sterile, wound measurement tool on top of the wound.
- Conditions
- Wound Heal, Wound Infection, Wound Healing Delayed, Wound of Skin, Infections
- Being tested
- PowerHeal™ Bioelectric Bandage, Standard of care dressing
- Keywords
- bandage
- Medical subject headings
- Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerHeal™ Bioelectric BandageDevice
Also called wireless electroceutical dressing (WED)
PowerHeal™ Bioelectric Bandage is a flexible fabric electroceutical based wound bandage offering ease of portability with long shelf life and stable for storage under any conditions. PowerHeal™ Bioelectric Bandage may be preventively used on fresh wounds. PowerHeal™ Bioelectric Bandage can directly disrupt the biofilm infection and enhance host resilience such as restoring skin barrier function (10). Productive management of bacterial biofilm/MDR infection or risk of such infection will minimize healing complications. This will result in fewer treatments and corrective procedures and earlier return to daily life for patients with traumatic wounds/burns.
Standard of care dressingDevice
SOC will be determined by local established guidelines and participant needs. This may include sutures, staples, liquid skin adhesives, adhesive surgical tape, gauze dressings and negative pressure wound therapy treatment strategies.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) Group | Active comparator | The choice of wound dressing and timing of dressing changes will be determined by the investigation doctor until the participant's wound heals, or until the participant is discharged. Receives: Device: Standard of care dressing |
| SOC + PowerHeal™ Bioelectric Bandage Group | Experimental | * The first SOC + PowerHeal™ Bioelectric Bandage will be applied within 24 hours of randomization.
* Each participant is expected to need at least 15 PowerHeal™ Bioelectric Bandages throughout the study.
PowerHeal™ Bandage Change Schedule
Dressing change frequency depends on how much fluid (exudate) the wound produces.
* Day 0-7 and Day 7-14: Minimum of 2 times per week, up to every other day.
* Day 14-28: Minimum of once per week, more as needed dependent on wound exudate. Receives: Device: PowerHeal™ Bioelectric Bandage; Device: Standard of care dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in wound area
Assess the efficacy of WED in promoting wound closure.
The digital photos taken at all visits will be quantitatively evaluated using ImageJ software that can measure the wound area. These measurements will be used for detailed analysis of wound closure over the period of study. Percentage decrease in wound area compared to SOC - from baseline (day 0) to final visit (day 28,± 2 days) will be calculated and analyzed, thus comparing range and rate of change between the two groups SOC and SOC + PowerHeal™ Bioelectric Bandage in aggregate.
Adjustment for the correlated variance due to repeated measures will be made throughout the analysis. All analysis will be conducted at 0.05 level of significance.
Measured: 28 days (± 2 days)
Secondary outcomes (1)
Change in microbial population - types of strains and numbers of colonies
Assess the efficacy of PowerHeal™ Bioelectric Bandage in wound infection management.
Swabs will be collected per standard local study guidelines. Clearance or presence of the numbers and types of clinically relevant microbes such as multidrug resistant (MDR) strains of ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp.), Candida auris, and all Gram-negative isolates of clinical concern (e.g. Serratia sp., Citrobacter sp.) will be determined to evaluate the change in microbial load. Clinical assessments of wound infection will be calculated and compared across baseline, Day 7 (± 2 days), Day 14 (± 2 days) and end of study samples.
The speciation provided by the laboratory conducting the analysis will determine changes in microbial pathogen over time. Adjustments will be made for variances due to repeated measures, and all analyses will be conducted at 0.05 level of significance.
Measured: 28 days (± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start11 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies 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
- Model description
- How well the PowerHeal™ Bioelectric Bandage-a special wireless bandage that uses gentle electrical signals-helps heal infected wounds caused by injuries, will be tested. The study will take place at a minimum of three medical sites in Ukraine, with support and training from experts in the United States at the University of Colorado and the University of Pittsburgh. All teams will stay in close contact throughout the study. This international collaboration aims to find out if this new type of bandage can reduce infections and speed up healing for people with serious wounds.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chandan Sen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Chandan Sen, University of Pittsburgh
- Investigators
- Chandan K. Sen, PhD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329114
- Sponsor's protocol ID
- STUDY25010029
- Other IDs
- MTEC-24-01-MPA-085
- Acronym
- HERO
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schultze T, Hogardt M, Velazquez ES, Hack D, Besier S, Wichelhaus TA, Rochwalsky U, Kempf VA, Reinheimer C. Molecular surveillance of multidrug-resistant Gram-negative bacteria in Ukrainian patients, Germany, March to June 2022. Euro Surveill. 2023 Jan;28(1):2200850. doi: 10.2807/1560-7917.ES.2023.28.1.2200850.
PubMed 36695452Banerjee J, Das Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam VV, Chang CJ, Sen CK. Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLoS One. 2014 Mar 3;9(3):e89239. doi: 10.1371/journal.pone.0089239. eCollection 2014.
PubMed 24595050Banerjee J, Das Ghatak P, Roy S, Khanna S, Hemann C, Deng B, Das A, Zweier JL, Wozniak D, Sen CK. Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm. PLoS One. 2015 Mar 24;10(3):e0119531. doi: 10.1371/journal.pone.0119531. eCollection 2015.
PubMed 25803639
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds
- ClinicalTrials.gov ID
- NCT07329114
- Acronym / sponsor ID
- HERO / STUDY25010029
- Conditions
- Wound Heal, Wound Infection, Wound Healing Delayed, Wound of Skin, Infections
- Keywords
- bandage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chandan SenUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Jan 2026 (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 clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better.
The main hypotheses it aims to answer are:
- WED promotes wound closure, as determined by wound area measurement
- WED manages wound infection in civilian and military wounds in Ukraine, as determined by clinical assessment of wound infection by measuring the numbers and types of relevant microbes.
Researchers will compare to see if PowerHeal™ Bioelectric Bandage the dressing used in the SOC group
Participants will get their dressings changed per the protocol, wound image and swab will be taken.
Detailed description
Managing bacterial burden is necessary for effective wound healing. Military wounds are severely complex due to rise in multidrug resistant bacterial infections. A FDA cleared commercially available disposable, wireless electroceutical dressing fabric is able to generate a low electric field in presence of exudate in the wound environment. The electric field, along with the micro-molar amounts of superoxide anion radicals that is generated in the wound microenvironment, initiate a bactericidal and a pro-healing signaling cascade resulting in improved wound healing without the encumbrance of a bulky dressing.
There will be five visits over the course of 28 ± 2 days. Participants will be randomized and divided into two groups: one group will receive the standard of care (SOC) dressing and the other will receive the bioelectric bandage. Dressing change intervals will depend on the group the participant randomized to and how exudating the wound is.
The investigation doctor will collect demographic data - such as, age, sex, race; general medical history, and targeted wound data -such as cause, size, location, duration and total number of traumatic wounds. Standard of care clinical lab results (complete blood count, liver and kidney functions, presence and level of inflammation) will also be collected to evaluate body functions and health status . No blood will be collected for this study.
Vital signs (body temperature, respiratory rate, heart rate, blood pressure, level of oxygen in blood) will be measured. The doctor will also look for signs of wound infection (of the investigation wound) including, redness, warmth, swelling, drainage, discoloration, friable granulation, foul odor, necrosis, and pustule/vesicles/boils. Participants will be asked about their pain experience compared to the moment of the injury.
A swab of the investigation wound will be collected per standard study guidelines at each investigation timepoint (unless the wound heals). A member of the study team will clean the wound using sterile sodium chloride solution, then gently rotate a sterile swab over a small area of the wound to collect a sample. All collected wound swabs will be sent to and processed in a central lab within Ukraine to check the infection status of the wound. Microbes detected in the wound will then be further analyzed in a separate central laboratory in the US to look at important factors such as antibiotic resistance. The results of the research wound swabs and analysis data will not be shared with the participant, or their medical care provider.
At each investigation timepoint, the investigation wound will also be photographed by the investigator or a member of the investigation team using the camera function on a standard smartphone to see if there is any change before and after receiving the treatment. The investigation wound will also be measured for size by holding a clear, sterile, wound measurement tool on top of the wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- How well the PowerHeal™ Bioelectric Bandage-a special wireless bandage that uses gentle electrical signals-helps heal infected wounds caused by injuries, will be tested. The study will take place at a minimum of three medical sites in Ukraine, with support and training from experts in the United States at the University of Colorado and the University of Pittsburgh. All teams will stay in close contact throughout the study. This international collaboration aims to find out if this new type of bandage can reduce infections and speed up healing for people with serious wounds.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) Group | Active comparator | Device: Standard of care dressingThe choice of wound dressing and timing of dressing changes will be determined by the investigation doctor until the participant's wound heals, or until the participant is discharged. |
| SOC + PowerHeal™ Bioelectric Bandage Group | Experimental | Device: PowerHeal™ Bioelectric Bandage, Device: Standard of care dressing* The first SOC + PowerHeal™ Bioelectric Bandage will be applied within 24 hours of randomization. * Each participant is expected to need at least 15 PowerHeal™ Bioelectric Bandages throughout the study. PowerHeal™ Bandage Change Schedule Dressing change frequency depends on how much fluid (exudate) the wound produces. * Day 0-7 and Day 7-14: Minimum of 2 times per week, up to every other day. * Day 14-28: Minimum of once per week, more as needed dependent on wound exudate. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female and male participants 18-105 years of age
- Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine
- At least one infected traumatic wound(s) between 20-40 cm2 in size. Probable or confirmed wound infection(s) will be determined by on-site physicians' clinical judgment and the presence of two or more of the following clinical indicators of wound infection:
- Participant or legal representative provides written informed consent prior to investigation procedures
- Participant understands and agrees to adhere to planned investigation procedures
Key exclusion criteria (13 listed)
- Allergy to silver or zinc
- Women who are pregnant or nursing
- Women of childbearing potential without a documented negative pregnancy test during the current hospitalization or women of childbearing potential who refused pregnancy testing during screening
- Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the investigator, and their respective family members
- > 60 days from the initial traumatic injury
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 |
|---|---|---|
| PowerHeal™ Bioelectric BandageAlso: wireless electroceutical dressing (WED)PowerHeal™ Bioelectric Bandage is a flexible fabric electroceutical based wound bandage offering ease of portability with long shelf life and stable for storage under any conditions. PowerHeal™ Bioelectric Bandage may be preventively used on fresh wounds. PowerHeal™ Bioelectric Bandage can directly disrupt the biofilm infection and enhance host resilience such as restoring skin barrier function (10). Productive management of bacterial biofilm/MDR infection or risk of such infection will minimize healing complications. This will result in fewer treatments and corrective procedures and earlier return to daily life for patients with traumatic wounds/burns. | Device | SOC + PowerHeal™ Bioelectric Bandage Group |
| Standard of care dressingSOC will be determined by local established guidelines and participant needs. This may include sutures, staples, liquid skin adhesives, adhesive surgical tape, gauze dressings and negative pressure wound therapy treatment strategies. | Device | SOC + PowerHeal™ Bioelectric Bandage Group, Standard of Care (SOC) Group |
Primary outcome
change in wound area
Time frame: 28 days (± 2 days)
Assess the efficacy of WED in promoting wound closure. The digital photos taken at all visits will be quantitatively evaluated using ImageJ software that can measure the wound area. These measurements will be used for detailed analysis of wound closure over the period of study. Percentage decrease in wound area compared to SOC - from baseline (day 0) to final visit (day 28,± 2 days) will be calculated and analyzed, thus comparing range and rate of change between the two groups SOC and SOC + PowerHeal™ Bioelectric Bandage in aggregate. Adjustment for the correlated variance due to repeated measures will be made throughout the analysis. All analysis will be conducted at 0.05 level of significance.
1 secondary outcome
Change in microbial population - types of strains and numbers of colonies
Time frame: 28 days (± 2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 36695452Schultze T, Hogardt M, Velazquez ES, Hack D, Besier S, Wichelhaus TA, Rochwalsky U, Kempf VA, Reinheimer C. Molecular surveillance of multidrug-resistant Gram-negative bacteria in Ukrainian patients, Germany, March to June 2022. Euro Surveill. 2023 Jan;28(1):2200850. doi: 10.2807/1560-7917.ES.2023.28.1.2200850.
- Background: PubMed 24595050Banerjee J, Das Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam VV, Chang CJ, Sen CK. Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLoS One. 2014 Mar 3;9(3):e89239. doi: 10.1371/journal.pone.0089239. eCollection 2014.
- Background: PubMed 25803639Banerjee J, Das Ghatak P, Roy S, Khanna S, Hemann C, Deng B, Das A, Zweier JL, Wozniak D, Sen CK. Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm. PLoS One. 2015 Mar 24;10(3):e0119531. doi: 10.1371/journal.pone.0119531. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Piya Das Ghatak, PhD, MS contact
Chandan K. Sen, PhD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PowerHeal™ Bioelectric Bandage in people with Wound Heal and Wound Infection, run by Chandan Sen at 1 site in Ukraine.
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 16 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 Ukraine. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shomita S Steiner, PhD, MS ((463) 237-8770, SSTEINER@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in wound area (time frame: 28 days (± 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329114, which also lists 3 linked publications.
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 6 Mar 2026.