Venous Leg UlcersNCT06652360
Chemical Debridement and Leg Ulcers
A study testing Chemical Debridement and Curettage debridement in people with Venous Leg Ulcers and Mixed Ulcer, run by DEBx Medical B.V. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers, Mixed Ulcer
- What is being tested?
- Chemical Debridement and Curettage debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2024to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Pioneer wound healing and lymphedema centres
Eastbourne
About this study
Official title: 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.
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.
Read the detailed 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
- Conditions
- Venous Leg Ulcers, Mixed Ulcer
- Being tested
- Chemical Debridement, Curettage debridement
- Keywords
- chemical debridement, mechanical debridement, topical dessicating agent, venous leg ulcer, chronic wound
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical DebridementDevice
The chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm.
Curettage debridementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Curettage debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface
Change in wound surface area (cm^2)
Measured: 12 weeks
Wound Debris
Change in the percentage of the wound bed covered with slough
Measured: 12 weeks
Secondary outcomes (8)
Wound healing
Number of healed wounds, according BWAT score ranging from 13 (minimal) - 65 (extreme severity)
Measured: 12 weeks
wound condition
Condition of the wound bed by percentage of granulation tissue, percentage covered in slough, exudate; Measured via visual assessment totalling up to 100% (e.g. 30% granulation, 25% slough, 25% necrosis, 20% exudate)
Measured: 12 weeks
Quality of Life
Health-related quality of life assessed using WoundQOL (an established validated questionair production a single number between 0-1 with 1 being the optimal quality of life)
Measured: 12 weeks
Patient Comfort in treatment process
Pain measured Participant pain measured using Visual Analogue Scale (VAS 0-10, 0 being painless and 10 being most pain to be imagined)
Measured: 12 weeks
Device Safety
Incidence of Treatment-related Adverse Events Incidence of Adverse Events of Special Interest
Measured: 12 weeks
Treatment Comfort in performance and acceptance
Participant and staff acceptance of the debridement methods by questionnaire. Score denoted in precentage with 100% being fully comfortable and accepted.
Measured: 12 weeks
wound condition
Condition of peri-ulcer skin and surrounding skin (healthy, bumpy, integrated, fragile))
Measured: 12 weeks
wound condition
Maloudour (yes, no);
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start18 Nov 2024
- Primary completion24 Dec 2025
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- DEBx Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652360
- Sponsor's protocol ID
- DCHEM2023_VLU
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06652360
- Acronym / sponsor ID
- DCHEM2023_VLU
- Conditions
- Venous Leg Ulcers, Mixed Ulcer
- Keywords
- chemical debridement, mechanical debridement, topical dessicating agent, venous leg ulcer, chronic wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- DEBx Medical B.V.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemical Debridement | Active comparator | Device: Chemical Debridement1 single treatment of chemical debridement will be applied in this arm at initiation visit. No repeated treatment done in this trial |
| Sharp debridement | Active comparator | Device: Curettage debridementIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemical DebridementThe chemical debridement is a dehydrating agent in a gel shape that will dry out the woundbed and biofilm. | Device | Chemical Debridement |
| Curettage debridementThe 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. | Device | Sharp debridement |
Primary outcome
Wound surface
Time frame: 12 weeks
Change in wound surface area (cm^2)
Wound Debris
Time frame: 12 weeks
Change in the percentage of the wound bed covered with slough
8 secondary outcomes
Wound healing
Time frame: 12 weeks
wound condition
Time frame: 12 weeks
Quality of Life
Time frame: 12 weeks
Patient Comfort in treatment process
Time frame: 12 weeks
Device Safety
Time frame: 12 weeks
Treatment Comfort in performance and acceptance
Time frame: 12 weeks
wound condition
Time frame: 12 weeks
wound condition
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemical Debridement and Curettage debridement in people with Venous Leg Ulcers and Mixed Ulcer, run by DEBx Medical B.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.