NCT07157657

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

Recruiting now Phase 2 Last updated 4 September 2025

What this trial tests

Phase 2 trial testing Surgical implantation with standard (DRM) or photosynthetic dermal regeneration matrices (PDRM) in same patient. in Cronic Full-thinkness Skin Wound in 20 participants. Currently enrolling.

Timeline

24 June 2025

Primary endpoint
1 May 2028

1 May 2028

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	24 June 2025
Primary completion	1 May 2028
Estimated completion	1 May 2028
Sites	1 location across Chile

Drugs / interventions tested

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

Conditions studied

• Cronic Full-thinkness Skin Wound — all drugs for Cronic Full-thinkness Skin Wound →
• Acute Full-thickness Skin Wound — all drugs for Acute Full-thickness Skin Wound →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

18 and older, any sex, with Cronic Full-thinkness Skin Wound or Acute Full-thickness Skin Wound. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.