THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers
Official title: Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Run by Biointelligent Technology Systems SL · NCT07617961 · Data updated 2026-11-12
This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Biointelligent Technology Systems SL Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | November 15, 2025 |
| Study ends | May 21, 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07617961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions suitable for topical THERAVEX treatment.
✕Probably not a fit
Patients with severe uncontrolled systemic infection or hypersensitivity to THERAVEX components may not benefit from this therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot observational evaluation examines the safety and potential healing benefits of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for cutaneous wounds, including burns, traumatic wounds, pressure ulcers, diabetic ulcers, and chronic lesions. Twenty-six adult patients received THERAVEX spray in addition to standard wound care, with outcomes focused on wound healing progression, epithelialization, tissue hydration, inflammatory signs, tolerance, and overall clinical progression. The study reports favorable tissue responses, progressive epithelial regeneration, reduced inflammation, and no treatment-related adverse events. The investigation discusses wound healing biology and how restoring the extracellular ionic microenvironment with this mineral-based formulation might support endogenous regenerative processes. The findings are preliminary and intended to inform future, more rigorous studies.
Why it matters
Potential benefit: If successful, patients could experience faster wound healing, better tissue quality, and fewer complications when THERAVEX is used alongside standard care.
How similar studies have gone: Previous observational applications of mineral-based wound care have shown signals of safety and potential benefit, but this specific formulation is novel and requires further study.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Biointelligent Technology Syst
Barcelona, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.