G-Wound (VZ for Wound Treatment)

Glock Health, Science and Research

Status: Completed

Conditions: Wound Heal; Wounds

Treatments: Procedure: Standard of care (SoC); Device: VZ powder (purified clinoptilolite)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04417647

G-Wound_01

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group 1

Experimental group

Description:

Proximal wound SoC treatment - Distal wound VZ application

Treatment:

Device: VZ powder (purified clinoptilolite)

Procedure: Standard of care (SoC)

Group 2

Experimental group

Description:

Distal wound SoC treatment - Proximal wound VZ application

Treatment:

Device: VZ powder (purified clinoptilolite)

Procedure: Standard of care (SoC)