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This is a prospective, randomized, open-label, controlled, exploratory trial that aims to investigate the local skin tolerability of topically administered VZ and to evaluate efficacy and safety parameters associated with improved wound condition and healing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Proximal wound SoC treatment - Distal wound VZ application |
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| Group 2 | Experimental | Distal wound SoC treatment - Proximal wound VZ application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VZ powder (purified clinoptilolite) | Device | VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective MeporeĀ® dressing). |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability of IMD | Local tolerability of IMD assessed using erythema severity score: a scale from 0 - 4 (0 = no visible reaction, 1 = faint, minimal erythema, 2 = erhythema, 3 = erythema with induration of vesicles, 4 = severe erythema with induration, vesicles or bullae or pustules and/ulceration) with 0 being best and 4 being worst. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound size | Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis | 14 days |
| Wound closure | Presence or absence of complete wound closure at End of Treatment (EoT) visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wolzt, Prof.Dr. | Department of Clinical Pharmacology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care (SoC) | Procedure | wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective MeporeĀ® dressing) will be applied to the SoC-assigned wound. |
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| 1 day |
| Wound healing and condition | Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator | 14 days |
| Histological evaluation | Descriptive histological evaluation of wound healing by H&E and Masson trichrome staining as well as by immunostaining against biomarkers of the biopsy specimens obtained at baseline and at EoT | 2 days |
| Investigator's satisfaction on topical applicability | Investigator's satisfaction on topical applicability of VZ evaluated via a 5-point Likert scale: a scale from 1 - 5: 5 = extremely satisfied, 4 = very satisfied, 3 = moderately satisfied, 2 = slightly satisfied, 1 = not at all satisfied) with 5 being best and 1 being worst. | 14 days |
| Change in local pain intensity | Change in local pain intensity based on the Visual Analogue Scale (VAS) when compared to SoC-treated wounds with a scale from 0-10: 0 - no pain and 10 - worst possible pain. | 14 days |
| Adverse Events and Serious Adverse Events | Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 28 days |