Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-11-18
2025-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemical Debridement
1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial
Chemical Debridement
The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.
Sharp debridement
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
Curettage debridement
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.
Interventions
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Chemical Debridement
The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.
Curettage debridement
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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DEBx Medical B.V.
INDUSTRY
Responsible Party
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Locations
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Pioneer wound healing and lymphedema centres
Eastbourne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DCHEM2023_VLU
Identifier Type: -
Identifier Source: org_study_id
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