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NCT Number: NCT06652360

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.

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Key information

Conditions

Venous Leg Ulcers Cardiovascular Diseases Leg Ulcer Mixed Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pioneer wound healing and lymphedema centres

Eastbourne, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemical Debridement

Device

The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.

Curettage debridement

Device

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.

Primary outcomes

  1. Wound surface

    Time frame: 12 weeks

    Change in wound surface area (cm^2)

  2. Wound Debris

    Time frame: 12 weeks

    Change in the percentage of the wound bed covered with slough

Secondary outcomes

  1. Wound healing

    Time frame: 12 weeks

    Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)

  2. wound condition

    Time frame: 12 weeks

    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)

  3. Quality of Life

    Time frame: 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)

  4. Patient Comfort in treatment process

    Time frame: 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)

  5. Device Safety

    Time frame: 12 weeks

    Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest

  6. Treatment Comfort in performance and acceptance

    Time frame: 12 weeks

    Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.

  7. wound condition

    Time frame: 12 weeks

    Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile))

  8. wound condition

    Time frame: 12 weeks

    Maloudour (yes, no);

Sponsors and collaborators

Lead sponsor

DEBx Medical B.V.

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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