NCT03960164

Brief Summary

The aim of the study is to demonstrate that dermal regeneration photosynthetic matrix applied in patients with acute clean skin wound is safe.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 21, 2023

Status Verified

July 1, 2022

Enrollment Period

4.2 years

First QC Date

May 20, 2019

Last Update Submit

November 20, 2023

Conditions

Skin Wound

Keywords

Acute skin lesionChronic skin ulcerTraumatic skin lesionPhotosynthetic matrixPhotosynthesis induced regenerationTissue regeneration

Outcome Measures

Primary Outcomes (2)

  • Systemic response to the implanted scaffold

    Percentage of patients presenting adverse effects, measured by hematological, coagulation and biochemical profiles as well as concentration of plasma cytokines and immune cells in peripheral blood.

    3 months

  • Local response to the implanted scaffold

    Percentage of patients presenting adverse effects, measured by: abnormal levels of macrophages, microorganisms in the implanted site and/or non-adherence of the scaffold to the wound bed.

    4-5 weeks

Secondary Outcomes (2)

  • Wound closure

    4-5 weeks

  • Patient self-perception

    Up to 10 days

Study Arms (1)

Patient group

EXPERIMENTAL

The group of patients included in the study following inclusion criteria with local (wound) and systemic test values prior and after to the application of the DRPM.

Combination Product: Dermal regeneration photosynthetic matrix (DRPM)

Interventions

Dermal regeneration photosynthetic matrix (DRPM)COMBINATION_PRODUCT

Primary Procedure: DRPM implantation 1. Wound bed preparation and cleaning. 2. DRPM implantation. 3. Illumination with LED device. Secondary Procedure: Autologous partial skin graft

Patient group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-thickness skin wounds.
  • Between 18 and 65 years old
  • Non-infected wounds (confirmed by quantitative culture of the tissue sample).
  • Homogeneous granulation of wound bed.
  • Approval of the informed consent for the study protocol.

You may not qualify if:

  • Ages under 18 years or older than 65 years.
  • Comorbidities such as autoimmune diseases, immunosuppression, coronary heart disease or occlusive arterial disease.
  • Chronic drug and/or alcohol abuse.
  • Psychiatric disorders that impede decision-making and continue treatment.
  • Patients suffering from an acute pathology other than the skin injury.
  • Full-thickness skin wounds in face.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital del Salvador

Santiago, RM, 7500787, Chile

Location

Instituto de Neurocirugía (INCA)

Santiago, Chile

Location

Red UC Christus

Santiago, Chile

Location

Related Publications (1)

  • Obaid ML, Camacho JP, Brenet M, Corrales-Orovio R, Carvajal F, Martorell X, Werner C, Simon V, Varas J, Calderon W, Guzman CD, Bono MR, San Martin S, Eblen-Zajjur A, Egana JT. A First in Human Trial Implanting Microalgae Shows Safety of Photosynthetic Therapy for the Effective Treatment of Full Thickness Skin Wounds. Front Med (Lausanne). 2021 Nov 30;8:772324. doi: 10.3389/fmed.2021.772324. eCollection 2021.

    PMID: 34917636RESULT

Related Links

Study Officials

  • Tomas Egaña, PhD.

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • Antonio Eblen-Zajjur, MD., PhD.

    Pontificia Universidad Catolica de Chile

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
There will be no masking of the treatment for researchers
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Single group to test safety of the treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

April 1, 2019

Primary Completion

June 30, 2023

Study Completion

November 1, 2023

Last Updated

November 21, 2023

Record last verified: 2022-07

Locations

CL(3)