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

Sponsor
Biointelligent Technology Systems SL
Study ID
NCT07617961
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • THERAVEX TISSUE CARE SPRAY PLUS — DEVICE
    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 Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Oct 2, 2025
Status verified
May 2026
Primary completion
Nov 15, 2025
Completion
May 21, 2027

Study Design

Enrollment
26 participants (estimated)

Primary Outcome Measure

Clinical progression of wound healing [ Time Frame: Up to 12 weeks ]

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