Chemical Debridement and Leg Ulcers

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcers; Mixed Ulcer

• Registration Number: NCT06652360
• Lead Sponsor: DEBx Medical B.V.

Brief 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.

Detailed Description

A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-22
• Status Verified: 2024-11
• Study Start: 2024-11-18
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound surface	12 weeks	Change in wound surface area (cm\^2)
Wound Debris	12 weeks	Change in the percentage of the wound bed covered with slough

Secondary Outcome Measures

Name	Time	Method
Wound healing	12 weeks	Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)
wound condition	12 weeks	Maloudour (yes, no);
Quality of Life	12 weeks	Health-related quality of life assessed using WoundQOL (an established validated questionair production a single number between 0-1 with 1 being the optimal quality of life)
Patient Comfort in treatment process	12 weeks	Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined)
Device Safety	12 weeks	Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest
Treatment Comfort in performance and acceptance	12 weeks	Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.

Trial Locations

Locations (1)

Pioneer wound healing and lymphedema centres; 🇬🇧 Eastbourne, United Kingdom