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Chemical Debridement and Leg Ulcers

Chemical Debridement and Leg Ulcers

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Eligibility

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 details
    Venous Leg Ulcers
    Mixed Ulcer

NCT06652360

DEBx Medical B.V.

28 August 2025

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