NCT07157657 Efficacy of a Photosynthetic Dermal Matrix for the Treatment of Full-Thickness Skin Wounds
| NCT ID | NCT07157657 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Cronic Full-thinkness Skin Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-06-24 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
José Tomás Egaña, PhD
STUDY DIRECTOR
Pontificia Universidad Catolica de Chile
Frequently Asked Questions
Who can join the NCT07157657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cronic Full-thinkness Skin Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07157657 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07157657 currently recruiting?
Yes, NCT07157657 is actively recruiting participants. Contact the research team at asadaran@gmail.com for enrollment information.
Where is the NCT07157657 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07157657 clinical trial?
NCT07157657 is sponsored by Pontificia Universidad Catolica de Chile. The principal investigator is José Tomás Egaña, PhD at Pontificia Universidad Catolica de Chile. The trial plans to enroll 20 participants.