Leg UlcerGELFINCT05148390
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
An observational study of Leg Ulcer and Diabetic Foot Ulcer, run by BSN Medical GmbH at 1 site in Germany.
Trial summary
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- What is being tested?
- Cutimed® Gelling Fiber
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2022to 26 Jul 2023
- Phase
- Observational
- 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
Study population: Representativeness of the investigation population is assumed to be high in relation to the target population since this is a PMCF study, where the IMD will be used within the intended purpose including the intended patient population. Therefore, the IMD will be tested by the population for whom it is in fact intended for once placed on the market among other intended users. Inclusion and exclusion criteria are aligned with the product´s intended purpose. No vulnerable subjects such as children, pregnant women, or sponsors or manufacturers staff will participate in this study guaranteed by specific inclusion and exclusion criteria.
Who may be able to join
- mentally and physically able to participate in study
- written informed consent to participate in the study
- Diagnosed wound indicated for treatment with Cutimed® Gelling Fiber for 4 weeks (except for internal body cavities and closed wounds)
- Subjects with more than one ulcer are eligible for inclusion, however only one ulcer per subject will be included in the study.
Who cannot join
- Sensitivity to or allergic reaction to the dressing or its components
- Participation in any other clinical study investigating drugs or medical devices
- Subjects presenting with wounds including internal body cavities or closed wounds
- Alcohol and drug addiction
- Pregnant or breast-feeding subjects
- Underlying diseases are not treated according to respective country-specific guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients.
Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites.
During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.
Read the detailed description
This Post Market Clinical Follow up (PMCF) study will examine product features of the CE-marked wound dressing after having received market authorization regarding the fulfilment of predefined requirements for the successful management of skin integrity during wound care. The primary purpose of this study is to evaluate clinical safety and performance of the product when used on several wounds in routine wound care without any additional invasive or burdensome methods and within the intended use.
As primary objective the dressing´s absorption performance and its ability to prevent exudate accumulation in the wound will be investigated. Further, device disintegration, need of debridement, wound and skin conditions, treatment related pain, general wound pain, dressing adhesion and quality of life as well as Helath Care professional's (HCP´s) and patient´s satisfaction are considered as secondary outcomes.
In total, 36 eligible subjects will be enrolled at 2 German sites, including 15 % dropouts.
5 on-site visits are to be performed by the subjects in the scope of routine weekly wound care/dressing change visits during 28 days (Day 0, Day7, Day 14, Day21, Day28). The IMD will be applied during each on-site visit including wound care, wound examination/documentation and dressing change according to HCP's judgment and individual circumstances of the wound. Photographic documentation of the wound and the wound with applied dressings will be performed and used for further automatic wound/tissue analyis. General wound pain as well as pain perceived during dressing change will be documented, as well as Wound-related Quality of life as well as Patient's/HCP's satisfaction with the product.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound, Abrasion, Laceration
- Being tested
- Cutimed® Gelling Fiber
- Medical subject headings
- Leg Ulcer, Diabetic Foot, Pressure Ulcer, Surgical Wound, Lacerations, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutimed® Gelling FiberDevice
application of dressing
What is being measured
The primary outcome is the main question the study is designed to answer.
Exudate absorption by IMD ('yes', 'no')
Percentage of subjects with exudate absorbed by the IMD per visit
Measured: day 7
Exudate absorption by IMD ('yes', 'no')
Percentage of subjects with exudate absorbed by the IMD per visit
Measured: day 14
Exudate absorption by IMD ('yes', 'no')
Percentage of subjects with exudate absorbed by the IMD per visit
Measured: day 21
Exudate absorption by IMD ('yes', 'no')
Percentage of subjects with exudate absorbed by the IMD per visit
Measured: day 28
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Percentage of subjects with remaining exudate in wound per amount and visit
Measured: day 7
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Percentage of subjects with remaining exudate in wound per amount and visit
Measured: day 14
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Percentage of subjects with remaining exudate in wound per amount and visit
Measured: day 21
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Percentage of subjects with remaining exudate in wound per amount and visit
Measured: day 28
Secondary outcomes (16)
Changes in need for debridement
Percentage of subjects with need for debridement per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Changes in debridement ease
Percentage of subjects per debridement ease ('easy', 'moderate', 'heavy', 'not applicable') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Changes in wound margin condition
Percentage of subjects per wound margin condition('intact', 'macerated', 'redness', 'ragged') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Changes in peri-wound skin condition
Percentage of subjects per peri-wound skin condition ('intact', 'macerated', 'redness', 'dry/flaky', 'edematous' ,'weeping') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Changes in wound tissue type
Percentage of subjects per wound tissue type ('epithelialization tissue', 'granulation tissue', 'slough', 'eschar/necrotic tissue', 'other') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Ease of application
Percentage of subjects per ease of application ('very easy', 'easy', 'difficult', 'very difficult') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Conformability during application
Percentage of subjects per conformability ('very good', 'good', 'poor', 'very poor') per visit
Measured: Throughout days 0, 7, 14, 21 and 28
Ease of removal
Percentage of subjects per ease of removal ('very easy', 'easy', 'difficult', 'very difficult') per visit
Measured: Throughout days 7, 14, 21 and 28
Dressing adherence on removal
Percentage of subjects per adherence ('none', 'minor', 'moderate', 'marked') per visit
Measured: Throughout days 7, 14, 21 and 28
Pain on removal
Mean pain perceived by subject using a pain ruler (scale 0-10) per visit
Measured: Throughout days 7, 14, 21 and 28
Changes in wound-pain
Mean pain perceived by subject using a pain ruler (scale 0-10) per visit
Measured: Throughout days 7, 14, 21 and 28
Changes in Wound-quality of life Wound-QoL
percentage change in Wound-QoL total scores and subscale scores ('body', 'psyche', 'everyday life' and standalone item) between both visits
Measured: Day 0 and Day 28
HCP Overall satisfaction
Percentage per HCP overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for final visit
Measured: day 28
Subject Overall satisfaction
Percent of patient overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for all patients at visit 5
Measured: day 28
Incidence of adverse events related to IMD
Total occurence of IMD related adverse events
Measured: Throughout days 0, 7, 14, 21 and 28
Incidence of device disintegration (removability in one piece)
Total occurence of IMD disintegration during removal
Measured: Throughout days 0, 7, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start24 Apr 2022
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arne Böhling, Dr., Study director, BSN Medical GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148390
- Sponsor's protocol ID
- C2820
- Acronym
- GELFI
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2021
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT05148390
- Acronym / sponsor ID
- GELFI / C2820
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound, Abrasion, Laceration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2022 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 8 Dec 2021 (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.
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients.
Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites.
During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.
Detailed description
This Post Market Clinical Follow up (PMCF) study will examine product features of the CE-marked wound dressing after having received market authorization regarding the fulfilment of predefined requirements for the successful management of skin integrity during wound care. The primary purpose of this study is to evaluate clinical safety and performance of the product when used on several wounds in routine wound care without any additional invasive or burdensome methods and within the intended use.
As primary objective the dressing´s absorption performance and its ability to prevent exudate accumulation in the wound will be investigated. Further, device disintegration, need of debridement, wound and skin conditions, treatment related pain, general wound pain, dressing adhesion and quality of life as well as Helath Care professional's (HCP´s) and patient´s satisfaction are considered as secondary outcomes.
In total, 36 eligible subjects will be enrolled at 2 German sites, including 15 % dropouts.
5 on-site visits are to be performed by the subjects in the scope of routine weekly wound care/dressing change visits during 28 days (Day 0, Day7, Day 14, Day21, Day28). The IMD will be applied during each on-site visit including wound care, wound examination/documentation and dressing change according to HCP's judgment and individual circumstances of the wound. Photographic documentation of the wound and the wound with applied dressings will be performed and used for further automatic wound/tissue analyis. General wound pain as well as pain perceived during dressing change will be documented, as well as Wound-related Quality of life as well as Patient's/HCP's satisfaction with the product.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representativeness of the investigation population is assumed to be high in relation to the target population since this is a PMCF study, where the IMD will be used within the intended purpose including the intended patient population. Therefore, the IMD will be tested by the population for whom it is in fact intended for once placed on the market among other intended users. Inclusion and exclusion criteria are aligned with the product´s intended purpose. No vulnerable subjects such as children, pregnant women, or sponsors or manufacturers staff will participate in this study guaranteed by specific inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- mentally and physically able to participate in study
- written informed consent to participate in the study
- Diagnosed wound indicated for treatment with Cutimed® Gelling Fiber for 4 weeks (except for internal body cavities and closed wounds)
- Subjects with more than one ulcer are eligible for inclusion, however only one ulcer per subject will be included in the study.
Key exclusion criteria (6 listed)
- Sensitivity to or allergic reaction to the dressing or its components
- Participation in any other clinical study investigating drugs or medical devices
- Subjects presenting with wounds including internal body cavities or closed wounds
- Alcohol and drug addiction
- Pregnant or breast-feeding subjects
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 |
|---|---|---|
| Cutimed® Gelling Fiberapplication of dressing | Device | – |
Primary outcome
Exudate absorption by IMD ('yes', 'no')
Time frame: day 7
Percentage of subjects with exudate absorbed by the IMD per visit
Exudate absorption by IMD ('yes', 'no')
Time frame: day 14
Percentage of subjects with exudate absorbed by the IMD per visit
Exudate absorption by IMD ('yes', 'no')
Time frame: day 21
Percentage of subjects with exudate absorbed by the IMD per visit
Exudate absorption by IMD ('yes', 'no')
Time frame: day 28
Percentage of subjects with exudate absorbed by the IMD per visit
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Time frame: day 7
Percentage of subjects with remaining exudate in wound per amount and visit
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Time frame: day 14
Percentage of subjects with remaining exudate in wound per amount and visit
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Time frame: day 21
Percentage of subjects with remaining exudate in wound per amount and visit
Exudate accumulation in the wound by IMD ( 'no', 'minimal amount', 'medium amount', 'high amount')
Time frame: day 28
Percentage of subjects with remaining exudate in wound per amount and visit
16 secondary outcomes
Changes in need for debridement
Time frame: Throughout days 0, 7, 14, 21 and 28
Changes in debridement ease
Time frame: Throughout days 0, 7, 14, 21 and 28
Changes in wound margin condition
Time frame: Throughout days 0, 7, 14, 21 and 28
Changes in peri-wound skin condition
Time frame: Throughout days 0, 7, 14, 21 and 28
Changes in wound tissue type
Time frame: Throughout days 0, 7, 14, 21 and 28
Ease of application
Time frame: Throughout days 0, 7, 14, 21 and 28
Conformability during application
Time frame: Throughout days 0, 7, 14, 21 and 28
Ease of removal
Time frame: Throughout days 7, 14, 21 and 28
Dressing adherence on removal
Time frame: Throughout days 7, 14, 21 and 28
Pain on removal
Time frame: Throughout days 7, 14, 21 and 28
Changes in wound-pain
Time frame: Throughout days 7, 14, 21 and 28
Changes in Wound-quality of life Wound-QoL
Time frame: Day 0 and Day 28
HCP Overall satisfaction
Time frame: day 28
Subject Overall satisfaction
Time frame: day 28
Incidence of adverse events related to IMD
Time frame: Throughout days 0, 7, 14, 21 and 28
Incidence of device disintegration (removability in one piece)
Time frame: Throughout days 0, 7, 14, 21 and 28
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 21 Feb 2024.
- 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.
Arne Böhling, Dr. study director
BSN Medical GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Ulcer and Diabetic Foot Ulcer, run by BSN Medical GmbH at 1 site in Germany.
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 4 inclusion and 6 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 21 Feb 2024. 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 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?
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?
Exudate absorption by IMD ('yes', 'no') (time frame: day 7). The study lists 8 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 21 Feb 2024.