Venous Leg UlcerNCT06300762
RCT Exudate Management Cutimed Sorbion Product Range
A study testing Superabsorbent dressing application in people with Venous Leg Ulcer, run by BSN Medical GmbH at 3 sites in 2 countries.
Trial summary
The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Superabsorbent dressing application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
- Participant is mentally and physically able to participate in this study
- Men, women, diverse ≥ 18 years
- Participant complies with study visit schedule
- Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
- Participant suffers from lower leg ulcer* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
Show all 11Show fewer
- Ulcer is not younger than 4 weeks and not older than 1 year
- Ulcer is ranging between 2 cm2 and 800 cm2
- One side of the ulcer is not extending 40 cm
- Depth of ulcer < 2 cm
- Ankle-brachial pressure index (ABPI) of >0.8 and ≤1.3, measurement not older than 12 months * Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.
Who cannot join
- Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
- Participant is expected not to be willing or able to follow the study outlines and requirements
- Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
- Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
- Participant uses any medication that could potentially delay the wound healing ability
- Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
Show all 9Show fewer
- Participant is pregnant or currently breastfeeding
- Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone
- 8. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sandra Tobisch contact
3 sites in 2 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
Northumbria Healthcare NHS Foundation Trust
Ashington, NE63 0HP
Debera Drew, 800-555-5555, nn@nn.dd
- Recruiting
Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
Wakefield, West Yorkshire, WF1 4DG
Martin Sylvester, 800-555-5555, nn@nn.nn
Germany1 site, 1 recruiting
- Recruiting
Niels Stensen Klinik, Christliches-Klinikum-Melle
Melle, Niedersachsten, 49624
Jan Heggemann
Sabine Guth
About this study
Official title: A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range
The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.
As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.
- Conditions
- Venous Leg Ulcer
- Being tested
- Superabsorbent dressing application
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superabsorbent dressing applicationDevice
Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate
| Study group | Role | What they receive |
|---|---|---|
| Cutimed Sorbion products | Experimental | Within this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment. Receives: Device: Superabsorbent dressing application |
| Zetuvit (RespoSorb) products | Active comparator | Within this arm the comperator products Zetuvit® Plus/(RespoSorb® Super), Zetuvit® Plus Silicone/(RespoSorb® Silicone) and Zetuvit® Plus Silicone Border/(RespoSorb® Silicone Border) will be used for exudate management. Receives: Device: Superabsorbent dressing application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exudate management performance
Capability to main exudate uptake and retention as well as leakage prevention
Measured: up to 30 days
Secondary outcomes (8)
Dressing change frequency
Number of required intermediate dressing changes between study visits and assessement fo reasons for
Measured: up to 30 days
Moisture-associated skin damages
Occurrence of moisture-associated skin damages
Measured: up to 30 days
Occurrence clinical relevant peri-wound skin changes
Effect of product use on peri-wound skin such as reddening, swelling, clinical relevant skin detoriations
Measured: up to 30 days
Changes in wound tissue and general wound pain
Effect of product use on the wound considering wound tissue and slough on the wound as well as the general wound pain assessed using a 11 visual analogue scale from 0-10 (0= not pain, 10=most imaginable pain for the participant)
Measured: up to 30 days
Need for debridement after product removal
Evaluation of the soft debridement effect of Cutimed Sorbion products during dressing removal: is the soft debrimdent supporting wound cleansing and eases addtional wound debridement
Measured: up to 30 days
Patient satisfaction with treatment and product
Patient´s impressions about treatment and felt protection for leakage when using the product and assessment of individually felt wearing comfort
Measured: final study visit
HCP satisfaction with treatment and product
HCP´s satisfaction with treatment and product performance to manage wound exudate, check if treatment need have been met be the product
Measured: final study visit
Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments)
Fourteen items are scored using a Likert-type scale as either 'not at all', 'a little', 'moderately', 'quite a lot' or 'very much'. Item data are calculated building a global score and the 3 subscores "Body", "Psyche/Well-being" and the "Everyday life". In increase in quality of life is indicated by decreasing sub- and/or global score.
Measured: day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start10 Aug 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300762
- Sponsor's protocol ID
- C3079
- Status last verified
- Jan 2025
- First submitted
- 20 Feb 2024
- Last updated
- 31 Jan 2025
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range
- ClinicalTrials.gov ID
- NCT06300762
- Acronym / sponsor ID
- C3079
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 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.
The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.
As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutimed Sorbion products | Experimental | Device: Superabsorbent dressing applicationWithin this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment. |
| Zetuvit (RespoSorb) products | Active comparator | Device: Superabsorbent dressing applicationWithin this arm the comperator products Zetuvit® Plus/(RespoSorb® Super), Zetuvit® Plus Silicone/(RespoSorb® Silicone) and Zetuvit® Plus Silicone Border/(RespoSorb® Silicone Border) will be used for exudate management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
- Participant is mentally and physically able to participate in this study
- Men, women, diverse ≥ 18 years
- Participant complies with study visit schedule
- Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
Key exclusion criteria (9 listed)
- Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
- Participant is expected not to be willing or able to follow the study outlines and requirements
- Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
- Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
- Participant uses any medication that could potentially delay the wound healing ability
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 |
|---|---|---|
| Superabsorbent dressing applicationCutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate | Device | Cutimed Sorbion products, Zetuvit (RespoSorb) products |
Primary outcome
Exudate management performance
Time frame: up to 30 days
Capability to main exudate uptake and retention as well as leakage prevention
8 secondary outcomes
Dressing change frequency
Time frame: up to 30 days
Moisture-associated skin damages
Time frame: up to 30 days
Occurrence clinical relevant peri-wound skin changes
Time frame: up to 30 days
Changes in wound tissue and general wound pain
Time frame: up to 30 days
Need for debridement after product removal
Time frame: up to 30 days
Patient satisfaction with treatment and product
Time frame: final study visit
HCP satisfaction with treatment and product
Time frame: final study visit
Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments)
Time frame: day 0 and day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- 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.
Sandra Tobisch contact
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superabsorbent dressing application in people with Venous Leg Ulcer, run by BSN Medical GmbH at 3 sites in 2 countries.
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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hardy Schweigel, PhD (+491522 ext. 7752954, hardy.schweigel@essity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exudate management performance (time frame: up to 30 days). 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 31 Jan 2025.