Diabetic UlcersNCT07312513
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
A study testing two sided debridement pad and one sided debridment pad in people with Diabetic Ulcers and Arterial Ulcers, run by Lohmann & Rauscher at 5 sites in Poland.
Trial summary
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers
- What is being tested?
- two sided debridement pad and one sided debridment pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesPoland
- Study dates
- 9 May 2025to 2 Apr 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
- Age ≥ 18 years
- Patient is legally capable
- Patient has signed written informed consent
- Presence of one of the following wounds
- Venous lower leg ulcer
- Arterial ulcer
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- Diabetic ulcer
- Pressure ulcer
- Post-operative wound healing by secondary intention
- Traumatic wound
- Surgical wound
- Burn or scald (grade III: after surgical debridement)
- Epidermolysis Bullosa
- Wound area >4cm2
- The entire wound area can be displayed on one photo from a distance of 25-30 cm
- Covered with at least 30% debris, necrosis, slough, fibrotic tissue
Who cannot join
- Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
- Pregnancy or breast feeding
- Patient is illiterate
- Participation in a interventional clinical trial within the last 14 days and during participation in this study
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
- severe pain or hyperesthesia in the wound area
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- history of drug or alcohol abuse
- chronic analgesic use (especially opioids) that could influence baseline pain perception
- cognitive impairment, which may affect the ability to accurately self-report pain
- Use of anaesthesia before the debridment procedure
- presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
MelissaMed Poradnia
Lodz, 94-102
MIKOMED Sp. z.o.o.
Lodz, 94-238
NZOZ Neuromed M. i M. Nastaj
Lublin, 20-640
Specjalistyczny Osrodek Leczniczo Badawczy
Ostróda, 14-100
Lecran - Centrum Opieki Nad Ranami-Kunickiego
Wroclaw, 54-616
About this study
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
Read the detailed description
This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers, Postoperative Wounds Healing by Secondary Intention, Burns and Scalds
- Being tested
- two sided debridement pad, one sided debridment pad
- Keywords
- Debridement, mechanical debridement
- Medical subject headings
- Varicose Ulcer, Pressure Ulcer, Burns, Epidermolysis Bullosa, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two sided debridement padDevice
two sided debridement pad
one sided debridment padDevice
one sided debridment pad
| Study group | Role | What they receive |
|---|---|---|
| Debrisoft Duo | Experimental | Patients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris. Receives: Device: two sided debridement pad |
| Debrisoft Pad | Active comparator | Patients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side. Receives: Device: one sided debridment pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.
Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).
Measured: 1 day
Secondary outcomes (8)
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator
The amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by the investigator.
Measured: 1 day
Rate of device-related adverse events (device safety)
Frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents.
Measured: 1 day
Change of wound bed condition, defined by the combination of the following parameters:
- Change in grade of exudate (from very high to none)
- Change in type of exudate (from haemorrhagic to serous)
- Change of the wound surrounding skin (presence or abscence of normal, erosive, dry/scaling, dry cracking, oeadematous, red or discoloured skin and cream residues)
- Change of the wound bed and wound edges (presence or abscence of debris, discoloration, maceration, hyperkeratosis, smooth skin, thickened/rolled edges, undermining, vital tissue, biofilm)
- Removal of biofilm (estimated by the user)
Measured: 1 day
Wound related pain
Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale
Measured: 1 day
Time needed for debridement
Time needed for the debridement procedure will be assessed using a stopper
Measured: 1 day
Amount of products
Amount of products that were used during one debridement session will be assessed.
Measured: 1 day
Patient satisfaction
Patient satisfaction with the treatment procedure on a scale from 1-5
Measured: 1 day
User satisfaction
User satisfaction assessed via a questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start9 May 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AXCELLANT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312513
- Sponsor's protocol ID
- 2024-03
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
- ClinicalTrials.gov ID
- NCT07312513
- Acronym / sponsor ID
- 2024-03
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers, Postoperative Wounds Healing by Secondary Intention, Burns and Scalds
- Keywords
- Debridement, mechanical debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Collaborators
- AXCELLANT
- Study start
- 9 May 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 31 Dec 2025 (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.
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.
Detailed description
This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debrisoft Duo | Experimental | Device: two sided debridement padPatients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris. |
| Debrisoft Pad | Active comparator | Device: one sided debridment padPatients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years
- Patient is legally capable
- Patient has signed written informed consent
- Presence of one of the following wounds
- Wound area >4cm2
Key exclusion criteria (11 listed)
- Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components
- Pregnancy or breast feeding
- Patient is illiterate
- Participation in a interventional clinical trial within the last 14 days and during participation in this study
- Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
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 |
|---|---|---|
| two sided debridement padtwo sided debridement pad | Device | Debrisoft Duo |
| one sided debridment padone sided debridment pad | Device | Debrisoft Pad |
Primary outcome
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.
Time frame: 1 day
Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).
8 secondary outcomes
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator
Time frame: 1 day
Rate of device-related adverse events (device safety)
Time frame: 1 day
Change of wound bed condition, defined by the combination of the following parameters:
Time frame: 1 day
Wound related pain
Time frame: 1 day
Time needed for debridement
Time frame: 1 day
Amount of products
Time frame: 1 day
Patient satisfaction
Time frame: 1 day
User satisfaction
Time frame: 1 day
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two sided debridement pad and one sided debridment pad in people with Diabetic Ulcers and Arterial Ulcers, run by Lohmann & Rauscher at 5 sites in Poland.
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 16 inclusion and 11 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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?
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T. (time frame: 1 day). 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 3 Sep 2026.