Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

Diabetic Foot Ulcer Clinical Trial

— GELFI  

Official title:

Prospective Observational Explorative Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148390
• Other study ID #: C2820
• Status: Completed
• Start date: April 24, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: November 2023
• Source: BSN Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Abrasion
• Burn, Partial Thickness
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Laceration
• Lacerations
• Leg Ulcer
• Pressure Ulcer
• Surgical Wound
• Ulcer
• Wounds and Injuries

Intervention

Device:
• Cutimed® Gelling Fiber
application of dressing

Locations

Country	Name	City	State
Germany	Christliches Klinikum Melle GmbH, Unfallchirurgie	Melle

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 7
Primary	Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 14
Primary	Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 21
Primary	Exudate absorption by IMD ('yes', 'no')	Percentage of subjects with exudate absorbed by the IMD per visit	day 28
Primary	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	day 7
Primary	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	day 14
Primary	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	day 21
Primary	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	day 28
Secondary	Changes in need for debridement	Percentage of subjects with need for debridement per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Changes in debridement ease	Percentage of subjects per debridement ease ('easy', 'moderate', 'heavy', 'not applicable') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Changes in wound margin condition	Percentage of subjects per wound margin condition('intact', 'macerated', 'redness', 'ragged') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Changes in peri-wound skin condition	Percentage of subjects per peri-wound skin condition ('intact', 'macerated', 'redness', 'dry/flaky', 'edematous' ,'weeping') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Changes in wound tissue type	Percentage of subjects per wound tissue type ('epithelialization tissue', 'granulation tissue', 'slough', 'eschar/necrotic tissue', 'other') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Ease of application	Percentage of subjects per ease of application ('very easy', 'easy', 'difficult', 'very difficult') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Conformability during application	Percentage of subjects per conformability ('very good', 'good', 'poor', 'very poor') per visit	Throughout days 0, 7, 14, 21 and 28
Secondary	Ease of removal	Percentage of subjects per ease of removal ('very easy', 'easy', 'difficult', 'very difficult') per visit	Throughout days 7, 14, 21 and 28
Secondary	Dressing adherence on removal	Percentage of subjects per adherence ('none', 'minor', 'moderate', 'marked') per visit	Throughout days 7, 14, 21 and 28
Secondary	Pain on removal	Mean pain perceived by subject using a pain ruler (scale 0-10) per visit	Throughout days 7, 14, 21 and 28
Secondary	Changes in wound-pain	Mean pain perceived by subject using a pain ruler (scale 0-10) per visit	Throughout days 7, 14, 21 and 28
Secondary	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	Day 0 and Day 28
Secondary	HCP Overall satisfaction	Percentage per HCP overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for final visit	day 28
Secondary	Subject Overall satisfaction	Percent of patient overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for all patients at visit 5	day 28
Secondary	Incidence of adverse events related to IMD	Total occurence of IMD related adverse events	Throughout days 0, 7, 14, 21 and 28
Secondary	Incidence of device disintegration (removability in one piece)	Total occurence of IMD disintegration during removal	Throughout days 0, 7, 14, 21 and 28