Chemical Debridement and 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.

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcers; Mixed Ulcer
• Intervention / Treatment: Device: Chemical Debridement; Device: Curettage debridement

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Eastbourne, United Kingdom
    • Pioneer wound healing and lymphedema centres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Chemical Debridement; The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.
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	Device: Curettage debridement; The use of a currette will clean the wound bed. Debridement by mechanically removing the necrotic tissue and biofilm. This is performed confrom the standard of care standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound surface	Change in wound surface area (cm^2)	12 weeks
Wound Debris	Change in the percentage of the wound bed covered with slough	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)	12 weeks
wound condition	Condition of the wound bed by percentage of granulation tissue, percentage covered in slough, exudate; Measured via visual assessment totalling up to 100% (e.g. 30% granulation, 25% slough, 25% necrosis, 20% exudate)	12 weeks
Quality of Life	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)	12 weeks
Patient Comfort in treatment process	Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined)	12 weeks
Device Safety	Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest	12 weeks
Treatment Comfort in performance and acceptance	Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.	12 weeks
wound condition	Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile))	12 weeks
wound condition	Maloudour (yes, no);	12 weeks

Collaborators and Investigators

• Sponsor: DEBx Medical B.V.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): December 24, 2025
• Study Completion (Actual): February 23, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: chronic wound; venous leg ulcer; mechanical debridement; chemical debridement; topical dessicating agent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer
• Other Study ID Numbers: DCHEM2023_VLU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No