Actively Recruiting
Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Led by Biointelligent Technology Systems SL · Updated on 2026-06-04
26
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
B
Biointelligent Technology Systems SL
Lead Sponsor
S
Sohag University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an additional topical treatment for managing various types of skin wounds, including burns, traumatic wounds, pressure ulcers, diabetic foot ulcers, and other chronic ulcers. This pilot observational study involves 26 adult patients and focuses on how the spray may support the natural healing process of skin wounds by improving tissue regeneration and reducing inflammation. The treatment involves applying the mineral-based THERAVEX Tissue Care Spray Plus directly onto the cleaned wound surface alongside standard wound care practices. The spray is designed to help restore the wound environment by promoting tissue hydration, epithelial regeneration, granulation tissue formation, and reducing signs of inflammation. Patients receive this combined treatment during the study period. Participants undergo regular medical evaluations and photographic documentation to monitor wound healing progression up to 12 weeks. Researchers assess tissue hydration, inflammation, wound appearance, and local tolerance to the spray. They also observe any adverse events or allergic reactions. The study aims to gather preliminary data to support further controlled research on this wound care approach.
CONDITIONS
Brief Title
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Patients with burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions
- Patients suitable for topical treatment with THERAVEX Tissue Care Spray Plus
You will not qualify if you...
- Known allergy or hypersensitivity to any component of THERAVEX Tissue Care Spray Plus
- Severe uncontrolled systemic infection requiring immediate surgical intervention
- Participation in another interventional clinical study that could interfere with wound healing assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 weeks
Participants receive THERAVEX Tissue Care Spray Plus applied directly onto the wound surface following standard wound cleaning procedures as an adjunctive supportive therapy combined with standard wound care management.
Duration - Up to 12 weeks
Participants undergo periodic medical evaluation and photographic documentation during the healing process to assess wound hydration, inflammatory signs, tissue appearance, granulation tissue formation, epithelialization progression, local tolerance, and adverse events.
Periodic visits during healing process
Trial Site Locations
Total: 1 location
1
Biointelligent Technology Syst
Barcelona, Spain, 08009
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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