Chemical Debridement and Leg Ulcers

DEBx Medical B.V.

Status: Enrolling

Conditions: Mixed Ulcer; Venous Leg Ulcers

Treatments: Device: Curettage debridement; Device: Chemical Debridement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06652360

DCHEM2023_VLU

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Chemical Debridement

Active Comparator group

Description:

1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial

Treatment:

Device: Chemical Debridement

Sharp debridement

Active Comparator group

Description:

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

Treatment:

Device: Curettage debridement