Comparing chemical and curettage methods for treating leg ulcers
A Pilot Study to Investigate the Relative Effectiveness and Safety of Chemical Wound Debridement and Curettage in the Treatment of Venous and Mixed Aetiology Leg Ulcers.
This study is testing whether a chemical method or a scraping method works better and is safer for treating stubborn leg ulcers in people who have had them for at least six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | DEBx Medical B.V. Industry-sponsored |
| Locations | 1 site (Eastbourne) |
| Trial ID | NCT06652360 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness and safety of chemical wound debridement compared to curettage in treating venous and mixed aetiology leg ulcers. Participants will have chronic wounds that have persisted for at least six weeks and will be assessed for their suitability based on specific criteria. The study will take place in the United Kingdom, focusing on patients with visible slough in their wounds. The outcomes will help determine which debridement method is more beneficial for healing these types of ulcers.
Who should consider this trial
Good fit: Ideal candidates are individuals with venous or mixed aetiology leg ulcers that have been present for at least six weeks.
Not a fit: Patients with clinically infected wounds or those with contraindications to the treatments being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from chronic leg ulcers.
How similar studies have performed: While this approach is being tested in this pilot study, similar studies have shown promise in the effectiveness of various debridement methods for chronic wounds.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with a venous leg ulcer or mixed aetiology ulcer. * Duration of wound ≥ 6 weeks ≤ 5 years * Wound is ≥ 5 cm2 ≤ 200cm2 * Presence of at least 25% visible slough within the wound bed * The Participant must be able to understand the study and provide written informed consent * No clinical signs of infection Exclusion Criteria: * Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial * Current local or systemic antibiotics in the week prior to inclusion * Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema * Prolonged treatment with immunosuppressive agents or high dose corticosteroids * Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse) * Participants who have participated in a clinical trial on wound healing within the past month * Participants with a known history of non- adherence with medical treatment
Where this trial is running
Eastbourne
- Pioneer wound healing and lymphedema centres — Eastbourne, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Johannes Snels, MSc
- Email: info@debx-medical.com
- Phone: +31 639084549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.