G-Wound (VZ for Wound Treatment)
Primary Purpose
Wounds, Wound Heal
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
VZ powder (purified clinoptilolite)
Standard of care (SoC)
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring Wound, Healing
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects
- Age 18-45 years at time of screening
- Subjects are in good clinical and mental health as established by medical history and physical examination
- Subject agrees to be compliant with study related visit and treatment schedule
- Written informed consent
Exclusion Criteria:
- Regular use of medications affecting the blood clotting process (e.g. aspirin or any other over-the-counter medicine or complimentary health product affecting the blood clotting process) or immunosuppressive drugs. Aspirin should not be taken in the 10 days prior to study participation or during the study
- Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment
- History of cancer (except for non-melanoma skin cancer) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study
- Subjects with any known coagulation disorder
- Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring
- History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing
- Chronic inflammatory dermatological disease
- History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes
- Subjects diagnosed with Diabetes Type I or II
- Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer
- Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy
- Evidence of active infectious disease including HIV and hepatitis B or C
- Current smoker (or any kind of nicotine consumption)
- Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing
- Known hypersensitivity to aluminium and/or silicon
- Allergy requiring medical treatment within the last 4 weeks prior to screening
- Active infection or fever > 38°C within the last 7 days prior to randomization
- Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination
- Alcohol abuse or a positive urine screen for drugs of abuse at screening
- Participation in another clinical trial with an investigational day within the last 4 weeks before study participation
- Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Proximal wound SoC treatment - Distal wound VZ application
Distal wound SoC treatment - Proximal wound VZ application
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in wound size
Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis
Wound closure
Presence or absence of complete wound closure at End of Treatment (EoT) visit
Wound healing and condition
Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator
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
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.
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.
Adverse Events and Serious Adverse Events
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Full Information
NCT ID
NCT04417647
First Posted
June 2, 2020
Last Updated
November 12, 2020
Sponsor
Glock Health, Science and Research GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04417647
Brief Title
G-Wound (VZ for Wound Treatment)
Official Title
A Prospective, Randomized, Open-label, Controlled, Exploratory Trial to Investigate the Safety and Tolerability of Topically Administered VZ in Healthy Male Subjects With Artificial Dermal Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glock Health, Science and Research GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Wound Heal
Keywords
Wound, Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Proximal wound SoC treatment - Distal wound VZ application
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Distal wound SoC treatment - Proximal wound VZ application
Intervention Type
Device
Intervention Name(s)
VZ powder (purified clinoptilolite)
Intervention Description
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 Mepore® dressing).
Intervention Type
Procedure
Intervention Name(s)
Standard of care (SoC)
Intervention Description
wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.
Primary Outcome Measure Information:
Title
Local tolerability of IMD
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in wound size
Description
Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis
Time Frame
14 days
Title
Wound closure
Description
Presence or absence of complete wound closure at End of Treatment (EoT) visit
Time Frame
1 day
Title
Wound healing and condition
Description
Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator
Time Frame
14 days
Title
Histological evaluation
Description
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
Time Frame
2 days
Title
Investigator's satisfaction on topical applicability
Description
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.
Time Frame
14 days
Title
Change in local pain intensity
Description
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.
Time Frame
14 days
Title
Adverse Events and Serious Adverse Events
Description
Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects
Age 18-45 years at time of screening
Subjects are in good clinical and mental health as established by medical history and physical examination
Subject agrees to be compliant with study related visit and treatment schedule
Written informed consent
Exclusion Criteria:
Regular use of medications affecting the blood clotting process (e.g. aspirin or any other over-the-counter medicine or complimentary health product affecting the blood clotting process) or immunosuppressive drugs. Aspirin should not be taken in the 10 days prior to study participation or during the study
Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment
History of cancer (except for non-melanoma skin cancer) within the previous 12 months or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12 months before the first administration of investigational product or at any time during the study
Subjects with any known coagulation disorder
Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring
History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing
Chronic inflammatory dermatological disease
History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes
Subjects diagnosed with Diabetes Type I or II
Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer
Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy
Evidence of active infectious disease including HIV and hepatitis B or C
Current smoker (or any kind of nicotine consumption)
Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing
Known hypersensitivity to aluminium and/or silicon
Allergy requiring medical treatment within the last 4 weeks prior to screening
Active infection or fever > 38°C within the last 7 days prior to randomization
Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination
Alcohol abuse or a positive urine screen for drugs of abuse at screening
Participation in another clinical trial with an investigational day within the last 4 weeks before study participation
Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolzt, Prof.Dr.
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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G-Wound (VZ for Wound Treatment)
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