An interventional study of two sided debridement pad and one sided debridment pad in Diabetic Ulcers, Arterial Ulcers and Venous Ulcers, sponsored by Lohmann & Rauscher. Completed at 5 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Lohmann & Rauscher · Not applicable, Interventional, and Treatment
Among 15 studies in Varicose Ulcer with a site in Poland — 3 open to participants now, 4 under way, 2 of them phase 3. Varicose Ulcer · Poland.
Among the 15 studies in Varicose Ulcer with a site in Poland, this one is the 10th largest by enrollment of the 13 interventional ones, is one of 3 that started in 2025, is one of 6 with no phase, and was the 14th registered.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →3 of the 15 studies in Varicose Ulcer with a site in Poland are open now, in 10 countries. Each count lists the studies.
Of the 52 Varicose Ulcer studies recruiting now, 42 (81%) set no upper age limit and 5 (10%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →15 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2025.
Median enrollment 150 across the 13 interventional studies, 160 across the 2 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
15 of 15 have an industry lead sponsor. The 10 most frequent:
Lohmann & Rauscher is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Lohmann & Rauscher has 3 studies filed under Varicose Ulcer — fewer than ten, so there is no comparison to draw.
3 of the studies in Varicose Ulcer with a site in Poland that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568627Phase 3MediWound LtdA Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE) | 2026-12 |
| NCT06489028Phase 3RHEACELL GmbH & Co. KGAllogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) | 2027-04 |
| NCT05805137CutoSense OyMonitoring of Venous Ulcers Using a Bioimpedance Measurement Based Method and System | 2026-11-30 |
Among the 15 studies in Varicose Ulcer with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of one of the following wounds
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: two sided debridement pad
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.
Device: one sided debridment pad
two sided debridement pad
one sided debridment pad
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).
Time frame: 1 day
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.
Time frame: 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.
Time frame: 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)
Time frame: 1 day
Wound related pain
Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale
Time frame: 1 day
Time needed for debridement
Time needed for the debridement procedure will be assessed using a stopper
Time frame: 1 day
Amount of products
Amount of products that were used during one debridement session will be assessed.
Time frame: 1 day
Patient satisfaction
Patient satisfaction with the treatment procedure on a scale from 1-5
Time frame: 1 day
User satisfaction
User satisfaction assessed via a questionnaire
Time frame: 1 day
Change in wound size
Wound size will be compared before and after the debridement procedure
Time frame: 1 day
Results of biopsy or smear
If performed during clinical routine, results of biopsy or smear will be assessed
Time frame: 1 day
Removal of biofilm
Change in the presence of biofilm before and after debridement will be investigated using MolecuLightDX. This will only be done at one of the five participating sites.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Apr 2026, 10 months.
Of 66 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's 10 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Lohmann & Rauscher