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.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
United Kingdom
Pioneer wound healing and lymphedema centres
RECRUITING
Eastbourne
Contact Information
Primary
Johannes Snels, MSc
info@debx-medical.com
+31 639084549
Backup
Bert Quint, PhD
info@debx-medical.com
+31 85 0878096
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2025-09-26
Participants
Target number of participants: 80
Treatments
Active_comparator: Chemical Debridement
1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial
Active_comparator: Sharp debridement
In the control arm wound debridement by curettage will be performed at initiation visit and after 2 weeks when clinician deems this necessary, conform standard of care protocol
Related Therapeutic Areas
Sponsors
Leads: DEBx Medical B.V.