G-Wound (VZ for Wound Treatment)

NCT ID: NCT04417647

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2020-08-13

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

Conditions

Wounds; Wound Heal

Keywords

Wound; Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Proximal wound SoC treatment - Distal wound VZ application

Group Type: EXPERIMENTAL

VZ powder (purified clinoptilolite)

Intervention Type: 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 Mepore® dressing).

Standard of care (SoC)

Intervention Type: PROCEDURE

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.

Group 2

Distal wound SoC treatment - Proximal wound VZ application

Group Type: EXPERIMENTAL

VZ powder (purified clinoptilolite)

Intervention Type: 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 Mepore® dressing).

Standard of care (SoC)

Intervention Type: PROCEDURE

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.

Interventions

VZ powder (purified clinoptilolite)

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: DEVICE

Standard of care (SoC)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects

2. Age 18-45 years at time of screening

3. Subjects are in good clinical and mental health as established by medical history and physical examination

4. Subject agrees to be compliant with study related visit and treatment schedule

5. Written informed consent

Exclusion Criteria

1. 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

2. Use of topical (in the skin area of investigation) or systemic antibiotics within the last 4 weeks before study enrolment

3. 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

4. Subjects with any known coagulation disorder

5. Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an increased susceptibility to hypertrophic and keloid scarring

6. History of wound healing abnormalities or a medical condition that is known to be associated with abnormal wound healing

7. Chronic inflammatory dermatological disease

8. History of chronic autoimmune diseases such as, but not restricted to rheumatoid arthritis, inflammatory bowel disease, lupus erythematodes

9. Subjects diagnosed with Diabetes Type I or II

10. Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer

11. Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned punch biopsy

12. Evidence of active infectious disease including HIV and hepatitis B or C

13. Current smoker (or any kind of nicotine consumption)

14. Known allergies to biopsy numbing medication, wound cleansing solution and wound dressing

15. Known hypersensitivity to aluminium and/or silicon

16. Allergy requiring medical treatment within the last 4 weeks prior to screening

17. Active infection or fever > 38°C within the last 7 days prior to randomization

18. Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or physical examination

19. Alcohol abuse or a positive urine screen for drugs of abuse at screening

20. Participation in another clinical trial with an investigational day within the last 4 weeks before study participation

21. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Glock Health, Science and Research GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Wolzt, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

G-Wound_01

Identifier Type: -

Identifier Source: org_study_id