Chemical Debridement and Leg Ulcers

NCT06652360 | Completed

• 1 other identifier: DCHEM2023_VLU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcers; Mixed Ulcer

Keywords

chemical debridement; mechanical debridement; topical dessicating agent; venous leg ulcer; chronic wound

Outcome Measures

Primary Outcomes (2)

• Wound surface

  Change in wound surface area (cm\^2)

  12 weeks

• Wound Debris

  Change in the percentage of the wound bed covered with slough

  12 weeks

Secondary Outcomes (8)

• Wound healing

  12 weeks

• wound condition

  12 weeks

• Quality of Life

  12 weeks

• Patient Comfort in treatment process

  12 weeks

• Device Safety

  12 weeks

Study Arms (2)

Chemical Debridement

ACTIVE COMPARATOR

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

Device: Chemical Debridement

Sharp debridement

ACTIVE COMPARATOR

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

Device: Curettage debridement

Interventions

Chemical Debridement DEVICE

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

Chemical Debridement

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.

Sharp debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial
• 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

Sponsors & Collaborators

• DEBx Medical B.V.: lead

Study Sites (1)

Pioneer wound healing and lymphedema centres

Eastbourne, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 22, 2024
• Study Start: November 18, 2024
• Primary Completion: December 24, 2025
• Study Completion: February 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2024-11

Locations

GB (1)