Efficacy of BU002 to Debride Chronic Ulcers in older adults
Official title: New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers
Run by Universidad del Desarrollo · NCT07607106 · Data updated 2026-11-12
A new liquid BU002 is being tested to help clean and remove dead tissue from chronic ulcers in people over 60, and it will be compared with the usual Polyhexanide gel.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Universidad del Desarrollo Academic / other |
| Locations | 1 site (Santiago, Metropolitana de Santiago) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | October 1, 2025 |
| Study ends | December 2026 |
| Registry record updated | May 26, 2026 |
| Trial ID | NCT07607106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 60 with venous or diabetic-related foot ulcers between 4 and 30 cm², lasting 2 months to 2 years, and with controlled ankle-brachial index.
✕Probably not a fit
Patients with uncontrolled diabetes or hypertension, BMI over 35, recent cancer treatment, active infection, or allergies to study products may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests BU002, a liquid debridement product, in adults aged 60 and older with chronic venous or diabetic foot ulcers. Participants are randomly assigned to receive BU002 or polyhexanide gel 0.1% with betaine 0.1%, and neither participants nor most study staff know which treatment is given. The trial lasts four weeks with eleven wound-care visits to measure wound size and collect samples. Outcomes focus on wound debridement and changes in healing, under supervision of trained nurses at a single site in Santiago, Chile. The study is designed to determine if BU002 improves wound cleaning and healing compared with standard care.
Why it matters
Potential benefit: If BU002 proves effective, patients may experience faster wound cleaning and improved healing of chronic ulcers.
How similar studies have gone: Prior studies with debridement therapies have shown variable success; this trial investigates a novel BU002 composition against standard care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 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 (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.
Where it's running
-
Universidad del Desarrollo
Santiago, Metropolitana de Santiago, Chile Recruiting
Study contacts
- Study coordinator: María B Olivares, PhD
- Email: molivares@udd.cl
- Phone: 562223279634
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating new treatments for nonhealing diabetic foot and venous leg ulcers.
This study is testing whether new treatments for stubborn diabetic foot and leg ulcers can help people heal better when combined with standard care compared to just standard care alone.
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This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.
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This trial tests whether adding one of four human placental membrane wraps to standard wound care helps people with nonhealing diabetic foot or venous leg ulcers heal faster and more completely than standard care alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.