Ulcer VenousNCT07607106
Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers
A study testing BU002 and Polyhexanide 0.1% and betaine 0.1% gel in people with Ulcer Venous and Ulcer Foot, run by Universidad del Desarrollo at 1 site in Chile.
Trial summary
This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ulcer Venous, Ulcer Foot
- What is being tested?
- BU002 and Polyhexanide 0.1% and betaine 0.1% gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2025to Dec 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization.
- A duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years.
- Age over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age.
- An ankle-brachial index between 0.6 and 1.3.
Who cannot join
- Morbid obesity (BMI > 35)
- History of cancer treatment in the last year
- Uncontrolled diabetes (Glycated Hemoglobin above 10 mg/dL)
- Uncontrolled hypertension (blood pressure readings greater than 140/90 mmHg)
- Patients with a known allergy to the components of the products under study.
- Patients with signs of infection or undergoing antibiotic therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Universidad del Desarrollo
Santiago, Metropolitana de Santiago
María B Olivares, PhD, 562223279634 ext. 3634, molivares@udd.cl
Daniela Constanza Espinoza, Nurse
About this study
Official title: New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers
This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel.
About 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results.
Read more
The study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and treat the wound. The study team will:
- Measure the size of the wound
- Take small samples from the wound to check for bacteria
- Ask questions about pain and general health
- Check blood flow in the legs
- Perform blood tests at the beginning A specialist doctor will examine the wound at the start and at the end of the study to see how it has improved.
Overall, this study aims to find out if the new treatment can help wounds heal better and more quickly than current standard care.
Taking part in the study is completely voluntary. Participants can leave the study at any time without affecting their usual medical care. All personal and medical information will be kept confidential.
- Conditions
- Ulcer Venous, Ulcer Foot
- Being tested
- BU002, Polyhexanide 0.1% and betaine 0.1% gel
- Medical subject headings
- Varicose Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BU002Device
Also called Debricim
BU002 is a composition intended for debridement and antibiofilm in wounds.
Polyhexanide 0.1% and betaine 0.1% gelDevice
Polihexanide combined with betaine is a debridement and antibiofilm comercial product.
| Study group | Role | What they receive |
|---|---|---|
| BU002 | Experimental | Participants will received BU002 as debridement treatment. Receives: Device: BU002 |
| Polihexanide Gel | Active comparator | Participants will received Polihexanide gel as debridement treatment. Receives: Device: Polyhexanide 0.1% and betaine 0.1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound area
The total wound area it will be measure by an image software (Ekare Insight)
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Change in wound area covered by slough and necrotic tissue
The area will be measured by an image software (Ekare Insight)
Measured: Baseline, 4 weeks
Change in wound bacterial load
The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer VenousStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Instituto Nacional de Heridas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607106
- Sponsor's protocol ID
- 2024-77
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers
- ClinicalTrials.gov ID
- NCT07607106
- Acronym / sponsor ID
- 2024-77
- Conditions
- Ulcer Venous, Ulcer Foot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Collaborators
- Fundación Instituto Nacional de Heridas
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 May 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.
This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel.
About 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results.
The study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and treat the wound. The study team will:
- Measure the size of the wound
- Take small samples from the wound to check for bacteria
- Ask questions about pain and general health
- Check blood flow in the legs
- Perform blood tests at the beginning A specialist doctor will examine the wound at the start and at the end of the study to see how it has improved.
Overall, this study aims to find out if the new treatment can help wounds heal better and more quickly than current standard care.
Taking part in the study is completely voluntary. Participants can leave the study at any time without affecting their usual medical care. All personal and medical information will be kept confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BU002 | Experimental | Device: BU002Participants will received BU002 as debridement treatment. |
| Polihexanide Gel | Active comparator | Device: Polyhexanide 0.1% and betaine 0.1% gelParticipants will received Polihexanide gel as debridement treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization.
- A duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years.
- Age over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age.
- An ankle-brachial index between 0.6 and 1.3.
Key exclusion criteria (6 listed)
- Morbid obesity (BMI > 35)
- History of cancer treatment in the last year
- Uncontrolled diabetes (Glycated Hemoglobin above 10 mg/dL)
- Uncontrolled hypertension (blood pressure readings greater than 140/90 mmHg)
- Patients with a known allergy to the components of the products under study.
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 |
|---|---|---|
| BU002Also: DebricimBU002 is a composition intended for debridement and antibiofilm in wounds. | Device | BU002 |
| Polyhexanide 0.1% and betaine 0.1% gelPolihexanide combined with betaine is a debridement and antibiofilm comercial product. | Device | Polihexanide Gel |
Primary outcome
Change in wound area
Time frame: Baseline, 4 weeks
The total wound area it will be measure by an image software (Ekare Insight)
2 secondary outcomes
Change in wound area covered by slough and necrotic tissue
Time frame: Baseline, 4 weeks
Change in wound bacterial load
Time frame: Baseline, 4 weeks
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 26 May 2026.
Related trials for Ulcer Venous
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BU002 and Polyhexanide 0.1% and betaine 0.1% gel in people with Ulcer Venous and Ulcer Foot, run by Universidad del Desarrollo at 1 site in Chile.
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 4 inclusion and 6 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 26 May 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 Chile. 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 María B Olivares, PhD (562223279634 ext. 3634, molivares@udd.cl), 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: Baseline, 4 weeks). 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 26 May 2026.