An interventional study of BU002 and Polyhexanide 0.1% and betaine 0.1% gel in Ulcer Venous and Ulcer Foot, sponsored by Universidad del Desarrollo. Recruiting at 1 site in Chile. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Universidad del Desarrollo · Not applicable, Interventional, and Treatment
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:
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Universidad del Desarrollo is the lead sponsor of 24 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion criteria
Morbid obesity ( > 35)
History of cancer treatment in the last year
Uncontrolled diabetes ( 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will received BU002 as debridement treatment.
Device: BU002
Participants will received Polihexanide gel as debridement treatment.
Device: Polyhexanide 0.1% and betaine 0.1% gel
BU002 is a composition intended for debridement and antibiofilm in wounds.
Also known as: Debricim
Polihexanide combined with betaine is a debridement and antibiofilm comercial product.
Change in wound area
The total wound area it will be measure by an image software (Ekare Insight)
Time frame: Baseline, 4 weeks
Change in wound area covered by slough and necrotic tissue
The area will be measured by an image software (Ekare Insight)
Time frame: Baseline, 4 weeks
Change in wound bacterial load
The bacterial burden will be measure by swab sampling, then culturing to determine colony forming units.
Time frame: Baseline, 4 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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