An observational study in Chronic Wounds, Burns and Pressure Ulcer, sponsored by Biointelligent Technology Systems SL. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Biointelligent Technology Systems SL · Observational
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.
Cutaneous wound healing is a complex biological process involving multiple coordinated phases including hemostasis, inflammation, cellular proliferation, angiogenesis, extracellular matrix remodeling, and epithelial regeneration. Various pathological conditions such as burns, diabetic ulcers, pressure ulcers, and traumatic wounds may impair this physiological healing cascade, resulting in delayed tissue repair, chronic inflammation, increased susceptibility to infection, and poor regenerative outcomes.
Chronic wounds, particularly diabetic foot ulcers and pressure ulcers, represent a major global healthcare burden associated with significant morbidity, prolonged hospitalization, and elevated treatment costs. Impaired vascularization, persistent inflammatory activity, dysregulated fibroblast function, and altered extracellular microenvironment are recognized as key contributors to delayed wound healing.
THERAVEX Tissue Care Spray Plus is a mineral-based topical bioactive formulation designed to support physiological tissue regeneration through modulation of the extracellular ionic microenvironment. The formulation aims to restore physicochemical conditions favorable for endogenous regenerative mechanisms, including epithelial migration, angiogenesis, tissue hydration, and extracellular matrix remodeling.
This prospective pilot observational clinical evaluation investigated the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy in the management of cutaneous wounds, burns, pressure ulcers, traumatic lesions, diabetic ulcers, and chronic ulcers.
A total of 26 patients presenting with different types of cutaneous lesions were included in the observational evaluation. All patients received standard wound care management according to routine clinical practice combined with topical application of THERAVEX Tissue Care Spray Plus directly onto the wound surface following standard cleaning procedures.
Clinical follow-up included periodic medical evaluation and photographic documentation during the healing process. The study assessed wound hydration, inflammatory signs, tissue appearance, granulation tissue formation, epithelialization progression, local tolerance, and adverse events associated with treatment.
Preliminary clinical observations demonstrated progressive improvement in tissue hydration, reduction of inflammatory erythema, favorable granulation tissue formation, and progressive epithelial regeneration in the treated lesions. No treatment-related adverse reactions, allergic responses, or significant local intolerance were reported during the observation period.
The results of this pilot observational evaluation suggest that THERAVEX Tissue Care Spray Plus may represent a biologically compatible supportive therapy for cutaneous wound management and tissue regeneration, supporting the need for further controlled clinical investigations in wound care and regenerative medicine.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 26 is below the median of 64 across 163 observational studies indexed under Burns.
Browse Burns studies →Biointelligent Technology Systems SL is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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The study population consisted of 26 adult patients presenting with different types of cutaneous lesions, including burns, traumatic wounds, pressure ulcers, diabetic ulcers, and chronic cutaneous wounds. Patients received standard wound care management combined with topical application of THERAVEX Tissue Care Spray Plus as an adjunctive supportive therapy. Clinical follow-up included routine medical evaluation and photographic documentation during the wound healing process.
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinical progression of wound healing
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.
Time frame: Up to 12 weeks
Plan to share: No
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