THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08009
- Recruiting
- Biointelligent Technology Syst
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Contact:
- Maher Atari, PhD
- Phone Number: +34628379586
- Email: matari@biointelligentsl.com
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Contact:
- Email: matari@biointelligentsl.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical progression of wound healing
Time Frame: Up to 12 weeks
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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.
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Up to 12 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Son-Med-25-10-PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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