Chemical Debridement and Leg Ulcers

Last updated: March 5, 2025
Sponsor: DEBx Medical B.V.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stasis Dermatitis

Venous Leg Ulcers

Ulcers

Treatment

Chemical Debridement

Curettage debridement

Clinical Study ID

NCT06652360
DCHEM2023_VLU
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 informedconsent

  • No clinical signs of infection

Exclusion

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 thefollowing 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 woundhealing in the last 30 days (carcinoma, connective tissue disease, autoimmunedisease or alcohol or drug abuse)

  • Participants who have participated in a clinical trial on wound healing within thepast month

  • Participants with a known history of non- adherence with medical treatment

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Chemical Debridement
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
September 26, 2025

Study 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

Connect with a study center

  • Pioneer wound healing and lymphedema centres

    Eastbourne,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.