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RECRUITING
NCT07617961

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

Sponsor: Biointelligent Technology Systems SL

View on ClinicalTrials.gov

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.

Official title: Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

26

Start Date

2025-10-02

Completion Date

2027-05-21

Last Updated

2026-06-04

Healthy Volunteers

Yes

Interventions

DEVICE

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.

Locations (1)

Biointelligent Technology Syst

Barcelona, Spain