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NCT Number: NCT07617961

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical progression of wound healing

    Time frame: Up to 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Biointelligent Technology Systems SL

Industry

Collaborators

  • Sohag University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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