G-Wound (VZ for Wound Treatment)

NCT04417647 | Completed

• 1 other identifier: G-Wound_01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in wound size

  14 days

• Wound closure

  1 day

• Wound healing and condition

  14 days

• Histological evaluation

  2 days

• Investigator's satisfaction on topical applicability

  14 days

Study Arms (2)

Group 1

EXPERIMENTAL

Proximal wound SoC treatment - Distal wound VZ application

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

Group 2

EXPERIMENTAL

Distal wound SoC treatment - Proximal wound VZ application

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

Interventions

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 Mepore® dressing).

Group 1; Group 2

Standard of care (SoC) 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 1; Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glock Health, Science and Research GmbH: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Wolzt, Prof.Dr.

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: June 5, 2020
• Primary Completion: July 31, 2020
• Study Completion: August 13, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)