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WoundsNCT04417647

G-Wound (VZ for Wound Treatment)

A study testing VZ powder (purified clinoptilolite) in people with Wounds and Wound Heal, run by Glock Health, Science and Research GmbH at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Wounds, Wound Heal
What is being tested?
VZ powder (purified clinoptilolite)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustria
Study dates
5 Jun 2020to 13 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Department of Clinical Pharmacology, Medical University of Vienna

    Vienna

Other trials in Austria

About this study

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

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
Being tested
VZ powder (purified clinoptilolite), Standard of care (SoC)
Keywords
Wound, Healing
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

  • Standard of care (SoC)Procedure or surgery

    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.

Study groups in NCT04417647
Study groupRoleWhat they receive
Group 1ExperimentalProximal wound SoC treatment - Distal wound VZ application
Receives: Device: VZ powder (purified clinoptilolite); Procedure: Standard of care (SoC)
Group 2ExperimentalDistal wound SoC treatment - Proximal wound VZ application
Receives: Device: VZ powder (purified clinoptilolite); Procedure: Standard of care (SoC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 days

Secondary outcomes (7)

  1. Change in wound size

    Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis

    Measured: 14 days

  2. Wound closure

    Presence or absence of complete wound closure at End of Treatment (EoT) visit

    Measured: 1 day

  3. Wound healing and condition

    Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator

    Measured: 14 days

  4. 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

    Measured: 2 days

  5. 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.

    Measured: 14 days

  6. 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.

    Measured: 14 days

  7. Adverse Events and Serious Adverse Events

    Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start5 Jun 2020
  3. Primary completion31 Jul 2020
  4. Study completion13 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417647
Sponsor's protocol ID
G-Wound_01
Status last verified
Nov 2020
First submitted
2 Jun 2020
Last updated
13 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VZ powder (purified clinoptilolite) in people with Wounds and Wound Heal, run by Glock Health, Science and Research GmbH at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local tolerability of IMD (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417647.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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