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

NCT07617961 | Recruiting

• 1 other identifier: Son-Med-25-10-PD
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Wounds; Burns; Pressure Ulcer; Traumatic Wounds; Diabetic Foot Ulcer

Outcome Measures

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.

  Up to 12 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Presence of severe uncontrolled systemic infection requiring immediate surgical intervention.
• Participation in another interventional clinical study that could interfere with wound healing assessment.

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead
• Sohag University: collaborator

Study Sites (1)

Biointelligent Technology Syst

Barcelona, 08009, Spain

RECRUITING

MeSH Terms

Conditions

Burns; Pressure Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: October 2, 2025
• Primary Completion: November 15, 2025
• Study Completion (Estimated): May 21, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)