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Recruiting Observational

THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

NCT07617961 · tracked via the Priya Life Science Spain tracker
Sponsor
Biointelligent Technology Systems SL
Phase
Observational
Started
2025-10-02
Last updated
2026-06-04

Condition(s) studied

Chronic WoundsBurnsPressure UlcerTraumatic WoundsDiabetic Foot Ulcer

Investigational drug(s) / intervention(s)

THERAVEX TISSUE CARE SPRAY PLUS

THERAVEX TISSUE CARE SPRAY PLUS: Mineral-based topical bioactive spray designed to support physiological tissue regeneration and wound healing through modulation of the extracellular ionic microenvironment. THERAVEX Tissue Care Spray Plus was applied directly onto the wound surface following standard wound cleaning procedures as an adjunctive supportive therapy combined with standard wound care management. The formulation aims to promote tissue hydration, epithelial regeneration, granulation tissue formation, and reduction of inflammatory signs during the healing process.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Clinical progression of wound healing — Up to 12 weeks
    Clinical progression of wound healing assessed through evaluation of epithelialization, granulation tissue formation, tissue hydration, inflammatory signs, and overall wound appearance following treatment with THERAVEX Tissue Care Spray Plus.

Trial sites (1)

FacilityCityRegionStatus
Biointelligent Technology Syst Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07617961 on ClinicalTrials.gov ↗ ← All trials in Spain