THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiointelligent Technology Systems SL
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
THERAVEX TISSUE CARE SPRAY PLUS
DeviceMineral-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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biointelligent Technology Systems SL
Lead sponsor
Sohag University
Collaborator
Source ClinicalTrials.gov