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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-24

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient.

Intervention Type 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 matrices

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Autologous split-thickness skin grafting over implanted matrices

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes