Wound HealNCT06103812
Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds
An observational study of Wound Heal, run by Fidia Farmaceutici s.p.a. at 6 sites in Slovakia.
Trial summary
Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Hyalo4 Skin Gel
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 6 sitesSlovakia
- Study dates
- 24 Mar 2022to 31 Jan 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute or chronic wounds of different etiology (first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers),
Who may be able to join
- Signed written informed consent.
- Male or female ≥18 years.
- Patients selected to be treated with Hyalo4 Skin Gel.
- Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- Patients followed on an outpatient or home basis.
- Wound area ≥ 10 cm2 and ≤ 100 cm2
Who cannot join
- Patients < 18 years.
- Patients with acute or chronic infected lesions.
- Hospitalized patients.
- Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
- Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
- Stalled wound, without any clinical sign of healing progression
Show all 12Show fewer
- Immune system disorders
- Protein-energy malnutrition
- Alcohol, smoking and drug abuse (50ml of spirit, 0,5L of wine and 10 cigarettes/day)
- Conditions associated with hypoxia and/or poor tissue perfusion
- Corticosteroid, cytotoxic or immunosuppressive therapy.
- Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Slovakia6 sites, 6 recruiting
- Recruiting
Nemocnica Ružinov
Bratislava, 82606
Rudolf Sokol
- Recruiting
BeneDerma s.r.o.
Bratislava, 84102
Regina Paulínyová
- Recruiting
Pedi-Derma s.r.o.
Košice, 04001
Jagienka Jautová
- Recruiting
POLIKLINIKA ProCare KVP
Košice, 04023
Vladimír Medvecký
- Recruiting
Nemocnica s poliklinikou Spišská Nová Ves, a.s.
Spišská Nová Ves, 05201
Edward Hulo
- Recruiting
Fakultná nemocnica s poliklinikou Žilina
Žilina, 01207
Juraj Váňa
About this study
Official title: Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.
Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management
Read the detailed description
Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites.
A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.
The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
- Conditions
- Wound Heal
- Being tested
- Hyalo4 Skin Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalo4 Skin GelDevice
The evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hyalo4 Skin Gel | Not described Receives: Device: Hyalo4 Skin Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Hyalo4 Skin Gel treatment
The outcome will be measured as percentage of patients showing positive change in at least one of the following parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
Measured: 14 days
Secondary outcomes (3)
EQ5D-Patient's quality of life
Patient's quality of life assessment will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D).
Measured: 56 days
Performance of treatment
The performance of Hyalo4 Skin Gel will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of: type of wound bed tissue and exudate quantity and quality.
Measured: 7,21,28,42 and 56 days
Safety and Tollerability
The safety and tolerability of Hyalo4 Skin Gel will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start24 Mar 2022
- Primary completion28 Aug 2023
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103812
- Sponsor's protocol ID
- AQG06-21-01
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Observational Clinical Investigation to Evaluate the Performance and Safety of Hyalo4 Skin Gel in Management of Acute and Chronic Wounds.
- ClinicalTrials.gov ID
- NCT06103812
- Acronym / sponsor ID
- AQG06-21-01
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management
Detailed description
Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites.
A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.
The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyalo4 Skin Gel | – | Device: Hyalo4 Skin Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute or chronic wounds of different etiology (first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers),
Key inclusion criteria (6 listed)
- Signed written informed consent.
- Male or female ≥18 years.
- Patients selected to be treated with Hyalo4 Skin Gel.
- Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- Patients followed on an outpatient or home basis.
Key exclusion criteria (12 listed)
- Patients < 18 years.
- Patients with acute or chronic infected lesions.
- Hospitalized patients.
- Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
- Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyalo4 Skin GelThe evaluation of performance and safety of Hyalo4 Skin Gel in the amelioration of bed wound appearance after 14 days of treatment. | Device | Hyalo4 Skin Gel |
Primary outcome
Performance of Hyalo4 Skin Gel treatment
Time frame: 14 days
The outcome will be measured as percentage of patients showing positive change in at least one of the following parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
3 secondary outcomes
EQ5D-Patient's quality of life
Time frame: 56 days
Performance of treatment
Time frame: 7,21,28,42 and 56 days
Safety and Tollerability
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Wound Heal
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
Active, not recruiting
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Wound Heal, Ulcer
Active, not recruitingPhase 2
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum, Skin Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by Fidia Farmaceutici s.p.a. at 6 sites in Slovakia.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Slovakia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niocola Giordan (+39 349 823 2111, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Hyalo4 Skin Gel treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.