Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds

NCT07157657 | Recruiting Phase 2

• 2 other identifiers: CEC/21/202424IAT-272741
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cronic Full-thinkness Skin Wound; Acute Full-thickness Skin Wound

Keywords

Full-thickness skin wounds; Scaffolds for dermal regeneration; Matrix for dermal regeneration; Photosynthetic biomaterials; Oxygen producing biomaterials

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).

• Patient-Reported Impact

  From first intervention (Day 0) to readiness of granulation bed for autologus split-thickness sking grafting (up to 21 days).

• Autologous graft performance

  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

  3 months after first intervention (Day 0).

• Long-Term Skin Appearance

  3 months after first intervention (Day 0).

Study Arms (1)

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.

Biological: Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.; Procedure: Autologous split-thickness skin grafting over implanted matrices

Interventions

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.

Treatment with standard or photosynthetic dermal regeneration matrices in same patient.

Autologous split-thickness skin grafting over implanted matrices PROCEDURE

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.

Treatment with standard or photosynthetic dermal regeneration matrices in same patient.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Hospital del Trabajador de Santiago: collaborator
• SymbiOx Inc.: collaborator

Study Sites (1)

Hospital del Trabajador

Santiago, RM, 7501239, Chile

RECRUITING

Related Links

• Symbiox website

MeSH Terms

Interventions

GREM1 protein, human

Study Officials

• José Tomás Egaña, PhD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Central Study Contacts

Anil Sadarangani, PhD, MBA

CONTACT

+56-942766405; asadaran@gmail.com

José Tomás Egaña, PhD

CONTACT

+56-961555928; jte@uc.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 5, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning after publication with no end date.

Locations

CL (1)