Chemical Debridement and Leg Ulcers

Launched by DEBX MEDICAL B.V. · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of a treatment method called chemical debridement, which involves using special substances to help clean and heal venous leg ulcers and mixed ulcers. These types of ulcers are wounds that can develop on the legs due to poor blood circulation. The study is currently looking for participants, specifically adults aged 65 to 74, who have had a leg ulcer for at least six weeks and no longer than five years, and whose wound size is between 5 to 200 square centimeters. To be eligible, participants should also have visible dead tissue in the wound but no signs of infection.

If you choose to participate in this study, you can expect to receive the new treatment while being monitored by healthcare professionals. It’s important that you understand the study and agree to take part by signing a consent form. Participants who have certain medical conditions, are currently taking antibiotics, or have infections will not be eligible. This trial aims to find better ways to treat leg ulcers, which can significantly affect quality of life, so your participation could help improve care for others in the future.

Gender

ALL

Eligibility criteria

• 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