Wounds and Injuries

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Musculoskeletal Diseases

Burns

Pressure Ulcer

Ulcer

Diabetic Foot

Foot Ulcer

Surgical Wound

Leg Ulcer

Lacerations

Diabetic Angiopathies

Vascular Diseases

Skin Ulcer

Skin Diseases

Diabetes Mellitus

Diabetes Complications

Endocrine System Diseases

Diabetic Neuropathies

Foot Diseases

Cutimed® Gelling Fiber

Arne Böhling, Dr.

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.

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

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

Percentage of subjects with exudate absorbed by the IMD per visit

Percentage of subjects with remaining exudate in wound per amount and visit

Percentage of subjects with need for debridement per visit

Percentage of subjects per debridement ease ('easy', 'moderate', 'heavy', 'not applicable') per visit

Percentage of subjects per wound margin condition('intact', 'macerated', 'redness', 'ragged') per visit

Percentage of subjects per peri-wound skin condition ('intact', 'macerated', 'redness', 'dry/flaky', 'edematous' ,'weeping') per visit

Percentage of subjects per wound tissue type ('epithelialization tissue', 'granulation tissue', 'slough', 'eschar/necrotic tissue', 'other') per visit

Percentage of subjects per ease of application ('very easy', 'easy', 'difficult', 'very difficult') per visit

Percentage of subjects per conformability ('very good', 'good', 'poor', 'very poor') per visit

Percentage of subjects per ease of removal ('very easy', 'easy', 'difficult', 'very difficult') per visit

Percentage of subjects per adherence ('none', 'minor', 'moderate', 'marked') per visit

Mean pain perceived by subject using a pain ruler (scale 0-10) per visit

percentage change in Wound-QoL total scores and subscale scores ('body', 'psyche', 'everyday life' and standalone item) between both visits

Percentage per HCP overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for final visit

Percent of patient overall satisfaction category ('Very good', 'Good', 'Satisfactory', 'Sufficient', 'Insufficient') for all patients at visit 5

Total occurence of IMD related adverse events

Total occurence of IMD disintegration during removal

BSN Medical GmbH

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Diseases and Abnormalities at or Before Birth

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Rare Diseases

Coronary Artery Disease

Stroke

Lung Diseases

Ear Diseases

Joint Diseases

Congenital Abnormalities

Pneumonia

Coronary Disease

Myocardial Ischemia

Lung Diseases, Interstitial

Kidney Calculi

Calculi

Nephrolithiasis

Hyperaldosteronism

Adrenocortical Adenoma

Labyrinth Diseases

Labyrinthitis

Intracranial Arteriovenous Malformations

Arteriovenous Malformations

Adenoma

Ischemia

Heart Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Respiratory Tract Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Male Urogenital Diseases

Pathological Conditions, Anatomical

Vascular Malformations

Cardiovascular Abnormalities

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Otorhinolaryngologic Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Otitis

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Central Nervous System Vascular Malformations

Nervous System Malformations

Intracranial Arterial Diseases

Adenoma of the Adrenal Gland

Intracranial Arteriovenous Malformation

Hyperadrenalism

Micronutrients

All Drugs and Chemicals

Zinc

Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.

For the dual-layer spectral CT scanner (IQon®, Philips, Amsterdam, The Netherlands), the following parameters will be used for the acquisition:

* Tube potential 120 kVp;
* Tube current time product of 150 mAs;
* Gantry revolution time 0.33 s;
* Automatic exposure control (angular and longitudinal) combined xyz-axis;
* Beam collimation geometry 64 x 0.625 mm - scan field-of-view - 22 cm;

Spectral Photon Counting Computed Tomography (SPCCT)

The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field-of-view (FOV) of 168 mm in-plane, and a z-coverage of 20 mm. It is equipped with energy-sensitive photon-counting detectors relying on the direct conversion high band gap semiconductor of cadmium zinc telluride (CZT). The electronics comprises 5 rate counters with 5 different configurable energy thresholds. The SPCCT scanner has the following parameters:

* Base platform : iCT scanner
* Tube Voltage (kVp) : 120, capability for imaging at 80 and 100 kVp
* Tube current (mA) : 10 - 300
* Spatial Resolution : \> 30 lp/cm, ≤ 250 µm
* Z-coverage isocenter (mm) : 20 mm
* FOV (mm) : 500
* Minimum rotation time : 0.33 s/rotation
* Acquisition modes : Axial, Helical, Step \& Shoot

DECT (Dual Energy CT)

Philippe DOUEK, Pr

Adeline MANSUY

This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection.

Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

A single four-point scale will be used (1: unacceptable, 2: usable under limited conditions, 3: probably acceptable, 4: fully acceptable) based on the European guidelines on quality criteria for computed tomography

The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).

It will be calculated on a five-point scale (1: poor, 2: fair, 3: average, 4: good, 5: excellent) for each following criterion: noise, artifacts and sharpness.

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The CTDI is an estimation of the dose delivered to the organs for each acquired section that is based on acquisition parameters of a water phantom with a 32 cm diameter. The value is expressed in milligray (mGy).

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The DLP is obtained as follows: CTDI \* length of body explored = value in mGy.cm.

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The equivalent dose is obtained by multiplying the DLP to the specific organ conversion factor.

The noise by selecting regions of interest (ROI) will calculated.

The density (HU) by selecting regions of interest (ROI) will calculated.

The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.

Depiction of anatomical structures of interest will be graded on a four-point scale (1: visualization just possible, 2: unclear borders but different structures already visible, 3: very good visualization, well-defined anatomy, 4: perfect delineation of anatomy).

An average radiation dose delivered to the patients for each clinical application will be calculated.

Statistical comparison between SPCCT and DECT will be performed over all images and anatomical structures globally and also for each clinical application of interest.

Hospices Civils de Lyon

Inflammation

Necrosis

0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks

Placebo cream, administered twice a week for 4 weeks

LL37

Standard Wound Care

Eliza Miranda, MD

Luddwi A Rizky, MD

Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.

In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.

Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers

Measured by difference of granulation index by ImageJ

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Measured by the concentrations of IL-α and TNF-α by ELISA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice	NCT05148390	Leg Ulcer Diabetic Foot U... Pressure Ulcer Surgical Wound Abrasion Laceration Burn, Partial T... Oncology Wound	Cutimed® Gellin...	18 Years -	BSN Medical GmbH
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)	NCT04328181	Diabetic Foot U... Coronary Artery... Parenchymatous;... Kidney Stone Inner Ear Disea... Brain Stroke Joint Diseases Diabetes Adrenal Inciden... Hyperaldosteron... Macroadenoma Interstitial Lu... Intracranial Ar...	Spectral Photon... DECT (Dual Ener...	18 Years -	Hospices Civils de Lyon
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers	NCT04098562	Diabetic Foot U...	LL37 Standard Wound ...	18 Years - 60 Years	Fakultas Kedokteran Universitas Indonesia
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers	NCT04098562	Diabetic Foot U...	LL37 Standard Wound ...	18 Years - 60 Years	Fakultas Kedokteran Universitas Indonesia

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