Last updated: October 26, 2023
Sponsor: Fidia Farmaceutici s.p.a.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Hyalo4 Skin Gel
Clinical Study ID
NCT06103812
AQG06-21-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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; surgicalwounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- Patients followed on an outpatient or home basis.
- Wound area ≥ 10 cm2 and ≤ 100 cm2
Exclusion
Exclusion Criteria:
- 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 notusing effective contraception.
- Patients with acute or chronic lesions at high risk of infection, presenting at leastone of the following criteria:
- Stalled wound, without any clinical sign of healing progression
- Immune system disorders
- Protein-energy malnutrition
- Alcohol, smoking and drug abuse (50ml of spirit, 0,5L of wine and 10cigarettes/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 ofnon-compliance with the study procedures and or non-completion of the study accordingto investigator's judgement
Study Design
Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Hyalo4 Skin Gel
Phase:
Study Start date:
March 24, 2022
Estimated Completion Date:
January 31, 2024
Study Description
Connect with a study center
BeneDerma s.r.o.
Bratislava, 84102
SlovakiaActive - Recruiting
Nemocnica Ružinov
Bratislava, 82606
SlovakiaActive - Recruiting
POLIKLINIKA ProCare KVP
Košice, 04023
SlovakiaActive - Recruiting
Pedi-Derma s.r.o.
Košice, 04001
SlovakiaActive - Recruiting
Nemocnica s poliklinikou Spišská Nová Ves, a.s.
Spišská Nová Ves, 05201
SlovakiaActive - Recruiting
Fakultná nemocnica s poliklinikou Žilina
Žilina, 01207
SlovakiaActive - Recruiting
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