Photosynthetic dermal matrix for healing full-thickness skin wounds
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
This trial tests whether adding oxygen-producing microalgae to dermal scaffolds helps adults with acute or chronic full-thickness wounds heal faster and with fewer infections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, RM) |
| Trial ID | NCT07157657 on ClinicalTrials.gov |
What this trial studies
This Phase 2, interventional trial compares standard dermal regeneration matrices (DRM) with identical matrices that contain photosynthetic microalgae (PDRM). Treatments are applied to randomly assigned areas of the same wound or to different wounds on the same patient, followed by autologous split-thickness skin grafting over the implanted matrices. Participants receive regular follow-up to track granulation tissue formation, infection rates, graft integration, and the quality of regenerated skin. The study enrolls adults with homogeneous full-thickness wounds between 25 and 200 cm² and uses within-patient comparisons to reduce variability.
Who should consider this trial
Good fit: Adults (≥18) with homogeneous acute or chronic full-thickness skin wounds sized 25–200 cm² who can consent and adhere to follow-up visits are the intended candidates.
Not a fit: Patients with wounds exposing bone, tendon, or major vessels, those with acute unrelated medical conditions, or individuals unable to adhere to the protocol are unlikely to benefit from this trial approach.
Why it matters
Potential benefit: If successful, the photosynthetic matrix could speed wound granulation, improve graft integration, and lower local infection rates by supplying oxygen directly to the wound bed.
How similar studies have performed: Preclinical and early laboratory work on photosynthetic biomaterials have shown promise for improving oxygenation, but clinical evidence in humans is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Santiago, RM
- Hospital del Trabajador — Santiago, Rm, Chile (Recruiting)
Study contacts
- Study coordinator: Anil Sadarangani, PhD, MBA
- Email: asadaran@gmail.com
- Phone: +56-942766405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.