Cronic Full-thinkness Skin WoundPhase 2NCT07157657
Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds
A Phase 2 study testing Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient. and Autologous split-thickness skin grafting over implanted matrices in people with Cronic Full-thinkness Skin Wound and Acute Full-thickness Skin Wound, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cronic Full-thinkness Skin Wound, Acute Full-thickness Skin Wound
- What is being tested?
- Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient. and Autologous split-thickness skin grafting over implanted matrices
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 24 Jun 2025to May 2028
- Phase
- Phase 2
- 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
Who may be able to join
- Patients covered by social insurance law or under the "Complementary Service Sales" (VSC) program, aged 18 years or older.
- Presence of full-thickness skin wounds.
- Wounds with homogeneous granulation tissue.
- Wound size between 25 cm² and 200 cm².
- Signed informed consent to participate in the study.
Who cannot join
- History of a psychiatric disorder that may impair decision-making or adherence to treatment.
- Presence of an acute medical condition unrelated to the wound at the time of enrollment.
- Wound with exposed bone, tendon, or major blood vessels.
- Psychosocial conditions that may hinder adherence to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital del Trabajador
Santiago, RM, 7501239
About this study
Official title: Evaluation of the Efficacy of a Dermal Regeneration Matrix With Photosynthetic Microalgae for the Treatment of Patients With Full-Thickness Skin Wounds: Phase 2 Study
The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds.
The primary objectives are to determine whether the use of photosynthetic scaffolds enhances wound granulation and reduces infection rates compared to standard dermal regeneration scaffolds. Additionally, the quality of the regenerated skin will be assessed and compared between treatment types.
Read more
Participants will:
- Receive treatment with either standard dermal regeneration scaffolds or identical scaffolds containing photosynthetic microalgae. These treatments will be applied either to randomly assigned areas of the same wound or to different wounds on the same patient.
- Undergo regular follow-up assessments to monitor wound healing progress, infection rates, graft integration, and the qualiy of the regenerated skin.
- Complete self-assessment questionnaires regarding their experience and perceived outcomes.
Read the detailed description
Chronic and acute skin wounds are a significant and growing public health concern, affecting millions of people worldwide and placing a substantial burden on healthcare systems. These wounds, often resulting from underlying conditions such as diabetes, vascular disease, or trauma, can take months or even years to heal, severely impacting patients' quality of life. As global populations age and chronic diseases become more prevalent, the need for more effective wound care solutions is becoming increasingly urgent.
One area of innovation in wound management involves the use of advanced biomaterials that support the body's natural regenerative processes. Dermal regeneration matrices (DRMs) are among the most promising of these technologies, providing a structural scaffold to facilitate tissue repair. However, a major limitation of current DRMs is the poor oxygenation at the wound site during the initial phases of healing-an issue that can delay granulation tissue formation, increase infection risk, and ultimately impair outcomes.
To address this challenge, a novel approach has been developed that incorporates photosynthetic microalgae into the scaffold itself. These microorganisms are capable of producing oxygen when exposed to light, offering a potential means of delivering localized oxygen directly to the wound bed. This photosynthetic dermal regeneration matrix (PDRM) is designed to create a more favorable microenvironment for tissue regeneration by enhancing local oxygen availability in situ.
The present study is a randomized, controlled clinical trial designed to evaluate the safety and efficacy of PDRMs in adult patients with acute and cronic full-thickness skin wounds. Outcomes in wounds treated with PDRMs will be compared to those treated with conventional DRMs. Key endpoints include wound closure, granulation tissue formation, infection rates, graft integration, and overall skin regeneration quality.
If effective, this approach could represent a significant advance in wound care, offering accelerated healing, reduced complications, and improved patient-reported outcomes. The strategy may also broaden the applicability of regenerative therapies in diverse clinical settings by enhancing the functionality of existing biomaterials.
- Being tested
- Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient., Autologous split-thickness skin grafting over implanted matrices
- Keywords
- Full-thickness skin wounds, Scaffolds for dermal regeneration, Matrix for dermal regeneration, Photosynthetic biomaterials, Oxygen producing biomaterials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.Biological
Under sterile conditions and appropriate anesthesia, standard dermal regeneration matrices (DRMs) and photosynthetic dermal regeneration matrices (PDRMs), containing live photosynthetic microalgae, are implanted in separate wound areas or in anatomically distinct wounds on the same patient. Each site is then covered with a transparent adhesive dressing. In the experimental (PDRM) area, a light-emitting dressing is applied to stimulate photosynthesis and promote localized oxygen production.
Autologous split-thickness skin grafting over implanted matricesProcedure or surgery
Approximately 21 days after the initial intervention, and once the wound bed meets predefined grafting criteria based on clinical evaluation, an autologous dermo-epidermal skin graft is performed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with standard or photosynthetic dermal regeneration matrices in same patient. | Experimental | Surgical implantation of dermal regeneration matrices:
Primary procedure: Participants will receive both a standard dermal regeneration matrix (DRM; control) and a photosynthetic dermal regeneration matrix (PDRM; experimental), which is seeded with Chlamydomonas reinhardtii microalgae. The two matrices will be implanted into randomized areas of the same full-thickness wound or into separate full-thickness wounds on the same patient. A light-emitting dressing will be placed over the wound area to activate photosynthesis in the PDRM, facilitating localized oxygen production.
Secondary procedure: Approximately 21 days after matrix implantation, once sufficient granulation tissue has formed, an autologous split-thickness skin graft will be applied to the wound areas. Receives: Biological: Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.; Procedure: Autologous split-thickness skin grafting over implanted matrices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound granulation rate
Time to wound bed readiness for autologous split-thickness skin grafting, measured in days from the implantation of the dermal regeneration matrix (with or without microalgae) to the clinical determination of over 95% of granulation tissue.
Wound bed readiness will be assessed using a standardized Clinical Follow-Up Form by at least two independent medical evaluators. Readiness is defined as the presence of well-vascularized, homogeneous granulation tissue deemed suitable for graft acceptance.
Based on manufacturer data, the expected time to graft readiness in the control (DRM) group is approximately 21 days post-implantation. The microalgae-containing matrix (PDRM) is hypothesized to reduce this time due local oxygen production.
Measured: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Secondary outcomes (5)
Incidence of wound Infections
The incidence amongst the treated individuals of clinically diagnosed wound infections in areas treated with standard dermal regeneration matrices (DRM) or photosynthetic dermal regeneration matrices (PDRM) will be assessed and compared. Diagnosis will be based on predefined clinical criteria, including signs of erythema, purulent exudate, increased local temperature, and pain, as evaluated by the clinical team.
Measured: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Patient-Reported Impact
The subjective impact on patients, following treatment with dermal regeneration matrices with or without microalgae (DRM or PDRM) will be assessed using a self-evaluation questionnaire. Five parameters will be assessed (pain, itch, burning, smell, light annoyance), to give a total overall satisfaction percentage related to the presence of the treatment, with percentages closer to 0% indicating less discomfort and more satisfaction.
Measured: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Autologous graft performance
The performance of autologous dermo-epidermal grafts placed over control (DRM) or photosynthetic dermal regeneration matrice (PDRM), will be assessed through clinical evaluation. The area of adequate adherence of the autologous dermo-epidermal graft, relative to the initial area of the graft, will be measured. Aditionally, supplementary laboratory tests will be performed, to evaluate the overall health of the patient.
Measured: Following autologous graft implantation (Day 21), patients are monitored periodically for up to 3 months from the date of the original matrix implantation (Day 0).
Long-Term Skin Functionality
Functional outcomes of the regenerated skin will be assessed through mechanical skin measurements using a Cutometer instrument, to determine and compare the elasticity in areas treated with the different matrices, relative to adjacent healthy skin areas. Skin deformation curves (in mm/sec) will be obtained, and several elasticity parámeter will be calculated and compared between treatments.
Measured: 3 months after first intervention (Day 0).
Long-Term Skin Appearance
Aesthetic outcomes will be evaluated clinically and through patient self-assessment, using the POSAS 3.0 instrument (https://doi.org/10.1007/s11136-022-03244-6), in which an external evaluator, and the patient, score for different perceived characteristics of the treated area, ranging from 1 to 5, with 1 being the best case scenario, and 5 the worst case scenario. Differences betweeen the two treatments will be measured.
Measured: 3 months after first intervention (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start24 Jun 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cronic Full-thinkness Skin WoundStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a randomized experimental design. Each enrolled patient will receive both the experimentaland the control treatment. The photosynthetic dermal regeneration matrix (PDRM) will be applied to one wound area, while the standard dermal regeneration matrix (DRM) will be applied to a separate area within the same wound or to a separate, anatomically distinct wound on the same patient. The allocation of wound areas to PDRM or DRM treatment will be randomized to minimize bias and allow within-subject comparison.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Trabajador de Santiago, SymbiOx Inc.
- Responsible party
- Principal investigator, Jose Tomas Egaña, Pontificia Universidad Catolica de Chile
- Investigators
- José Tomás Egaña, PhD, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157657
- Sponsor's protocol ID
- CEC/21/2024
- Other IDs
- 24IAT-272741
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of research articles
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Dermal Regeneration Matrix With Photosynthetic Microalgae for the Treatment of Patients With Full-Thickness Skin Wounds: Phase 2 Study
- ClinicalTrials.gov ID
- NCT07157657
- Acronym / sponsor ID
- CEC/21/2024
- Keywords
- Full-thickness skin wounds, Scaffolds for dermal regeneration, Matrix for dermal regeneration, Photosynthetic biomaterials, Oxygen producing biomaterials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Hospital del Trabajador de Santiago, SymbiOx Inc.
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Sep 2025 (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.
The goal of this clinical trial is to evaluate whether the incorporation of photosynthetic microalgae into scaffolds for dermal regeneration improves healing outcomes in adult patients with acute and cronic full-thickness skin wounds.
The primary objectives are to determine whether the use of photosynthetic scaffolds enhances wound granulation and reduces infection rates compared to standard dermal regeneration scaffolds. Additionally, the quality of the regenerated skin will be assessed and compared between treatment types.
Participants will:
- Receive treatment with either standard dermal regeneration scaffolds or identical scaffolds containing photosynthetic microalgae. These treatments will be applied either to randomly assigned areas of the same wound or to different wounds on the same patient.
- Undergo regular follow-up assessments to monitor wound healing progress, infection rates, graft integration, and the qualiy of the regenerated skin.
- Complete self-assessment questionnaires regarding their experience and perceived outcomes.
Detailed description
Chronic and acute skin wounds are a significant and growing public health concern, affecting millions of people worldwide and placing a substantial burden on healthcare systems. These wounds, often resulting from underlying conditions such as diabetes, vascular disease, or trauma, can take months or even years to heal, severely impacting patients' quality of life. As global populations age and chronic diseases become more prevalent, the need for more effective wound care solutions is becoming increasingly urgent.
One area of innovation in wound management involves the use of advanced biomaterials that support the body's natural regenerative processes. Dermal regeneration matrices (DRMs) are among the most promising of these technologies, providing a structural scaffold to facilitate tissue repair. However, a major limitation of current DRMs is the poor oxygenation at the wound site during the initial phases of healing-an issue that can delay granulation tissue formation, increase infection risk, and ultimately impair outcomes.
To address this challenge, a novel approach has been developed that incorporates photosynthetic microalgae into the scaffold itself. These microorganisms are capable of producing oxygen when exposed to light, offering a potential means of delivering localized oxygen directly to the wound bed. This photosynthetic dermal regeneration matrix (PDRM) is designed to create a more favorable microenvironment for tissue regeneration by enhancing local oxygen availability in situ.
The present study is a randomized, controlled clinical trial designed to evaluate the safety and efficacy of PDRMs in adult patients with acute and cronic full-thickness skin wounds. Outcomes in wounds treated with PDRMs will be compared to those treated with conventional DRMs. Key endpoints include wound closure, granulation tissue formation, infection rates, graft integration, and overall skin regeneration quality.
If effective, this approach could represent a significant advance in wound care, offering accelerated healing, reduced complications, and improved patient-reported outcomes. The strategy may also broaden the applicability of regenerative therapies in diverse clinical settings by enhancing the functionality of existing biomaterials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a randomized experimental design. Each enrolled patient will receive both the experimentaland the control treatment. The photosynthetic dermal regeneration matrix (PDRM) will be applied to one wound area, while the standard dermal regeneration matrix (DRM) will be applied to a separate area within the same wound or to a separate, anatomically distinct wound on the same patient. The allocation of wound areas to PDRM or DRM treatment will be randomized to minimize bias and allow within-subject comparison.
| Arm | Type | Receives |
|---|---|---|
| Treatment with standard or photosynthetic dermal regeneration matrices in same patient. | Experimental | Biological: Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient., Procedure: Autologous split-thickness skin grafting over implanted matricesSurgical implantation of dermal regeneration matrices: Primary procedure: Participants will receive both a standard dermal regeneration matrix (DRM; control) and a photosynthetic dermal regeneration matrix (PDRM; experimental), which is seeded with Chlamydomonas reinhardtii microalgae. The two matrices will be implanted into randomized areas of the same full-thickness wound or into separate full-thickness wounds on the same patient. A light-emitting dressing will be placed over the wound area to activate photosynthesis in the PDRM, facilitating localized oxygen production. Secondary procedure: Approximately 21 days after matrix implantation, once sufficient granulation tissue has formed, an autologous split-thickness skin graft will be applied to the wound areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients covered by social insurance law or under the "Complementary Service Sales" (VSC) program, aged 18 years or older.
- Presence of full-thickness skin wounds.
- Wounds with homogeneous granulation tissue.
- Wound size between 25 cm² and 200 cm².
- Signed informed consent to participate in the study.
Key exclusion criteria (4 listed)
- History of a psychiatric disorder that may impair decision-making or adherence to treatment.
- Presence of an acute medical condition unrelated to the wound at the time of enrollment.
- Wound with exposed bone, tendon, or major blood vessels.
- Psychosocial conditions that may hinder adherence to the study protocol.
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 |
|---|---|---|
| Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.Under sterile conditions and appropriate anesthesia, standard dermal regeneration matrices (DRMs) and photosynthetic dermal regeneration matrices (PDRMs), containing live photosynthetic microalgae, are implanted in separate wound areas or in anatomically distinct wounds on the same patient. Each site is then covered with a transparent adhesive dressing. In the experimental (PDRM) area, a light-emitting dressing is applied to stimulate photosynthesis and promote localized oxygen production. | Biological | Treatment with standard or photosynthetic dermal regeneration matrices in same patient. |
| Autologous split-thickness skin grafting over implanted matricesApproximately 21 days after the initial intervention, and once the wound bed meets predefined grafting criteria based on clinical evaluation, an autologous dermo-epidermal skin graft is performed. | Procedure or surgery | Treatment with standard or photosynthetic dermal regeneration matrices in same patient. |
Primary outcome
Wound granulation rate
Time frame: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Time to wound bed readiness for autologous split-thickness skin grafting, measured in days from the implantation of the dermal regeneration matrix (with or without microalgae) to the clinical determination of over 95% of granulation tissue. Wound bed readiness will be assessed using a standardized Clinical Follow-Up Form by at least two independent medical evaluators. Readiness is defined as the presence of well-vascularized, homogeneous granulation tissue deemed suitable for graft acceptance. Based on manufacturer data, the expected time to graft readiness in the control (DRM) group is approximately 21 days post-implantation. The microalgae-containing matrix (PDRM) is hypothesized to reduce this time due local oxygen production.
5 secondary outcomes
Incidence of wound Infections
Time frame: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Patient-Reported Impact
Time frame: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).
Autologous graft performance
Time frame: Following autologous graft implantation (Day 21), patients are monitored periodically for up to 3 months from the date of the original matrix implantation (Day 0).
Long-Term Skin Functionality
Time frame: 3 months after first intervention (Day 0).
Long-Term Skin Appearance
Time frame: 3 months after first intervention (Day 0).
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 5 Sep 2025.
- Symbiox websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication of research articles
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.
José Tomás Egaña, PhD study director
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient. and Autologous split-thickness skin grafting over implanted matrices in people with Cronic Full-thinkness Skin Wound and Acute Full-thickness Skin Wound, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 4 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 5 Sep 2025. 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 Chile. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Anil Sadarangani, PhD, MBA (+56-942766405, asadaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound granulation rate (time frame: From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).). 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 5 Sep 2025.