RecruitingNCT07617961

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

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

Sponsor

Biointelligent Technology Systems SL

Enrollment

26 participants

Start Date

Oct 2, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetic Foot Ulcer Burns Pressure ulcer Chronic wounds Traumatic Wounds

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called THERAVEX TISSUE CARE SPRAY PLUS for people with burns, chronic wounds, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETHERAVEX 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.