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Recruiting
NCT07617961
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Conditions: Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds, Diabetic Foot Ulcer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 26
Sponsor: Biointelligent Technology Systems SL
Location: Biointelligent Technology Syst Barcelona
Summary
Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.
Eligibility Criteria
Inclusion Criteria
Adult patients aged 18 years or older. Patients presenting with cutaneous wounds: burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions.
Patients considered clinically suitable for topical treatment with THERAVEX Tissue Care Spray Plus.
Exclusion Criteria Known allergy or hypersensitivity to any component of THERAVEX Tissue Care Spray Plus.
Presence of severe uncontrolled systemic infection requiring immediate surgical intervention.
Participation in another interventional clinical study that could interfere with wound healing assessment.
Source: ClinicalTrials.gov (NCT07617961). StuddyBuddy aggregates publicly available trial information.
