Chronic WoundsNCT07617961
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
An observational study of Chronic Wounds and Burns, run by Biointelligent Technology Systems SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Wounds, Burns, Pressure Ulcer
- What is being tested?
- THERAVEX TISSUE CARE SPRAY PLUS
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2025to 21 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Biointelligent Technology Syst
Barcelona, 08009
Maher Atari, PhD, +34628379586, matari@biointelligentsl.com
matari@biointelligentsl.com
About this study
Official title: Pilot Clinical Evaluation of 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.
Read the 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.
- Conditions
- Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds, Diabetic Foot Ulcer
- Being tested
- THERAVEX TISSUE CARE SPRAY PLUS
- Medical subject headings
- Burns, Pressure Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAVEX TISSUE CARE SPRAY PLUSDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start2 Oct 2025
- Primary completion15 Nov 2025
- Study completion21 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sohag University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617961
- Sponsor's protocol ID
- Son-Med-25-10-PD
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
- ClinicalTrials.gov ID
- NCT07617961
- Acronym / sponsor ID
- Son-Med-25-10-PD
- Conditions
- Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds, Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Collaborators
- Sohag University
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 21 May 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERAVEX TISSUE CARE SPRAY PLUSMineral-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. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Wounds and Burns, run by Biointelligent Technology Systems SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical progression of wound healing (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.