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Dermal Regeneration Photosynthetic Matrix (HULK)

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ClinicalTrials.gov Identifier: NCT03960164
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Hospital del Salvador
SymbiOx Inc.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.

Condition or disease Intervention/treatment Phase
Skin Wound Combination Product: Dermal regeneration photosynthetic matrix Early Phase 1

Detailed Description:

Safety of the dermal regeneration photosynthetic matrix (DRPM) will be conducted at the Departament of Plastic Surgery at Hospital del Salvador. This safety assessment represents the objetive 1 of this trial, and will be performed in 20 human patients (between 18-65 years old) without comorbidities, presenting non-infected acute wounds (confirmed by negative quantitative culture of tissue sample) and homogenous granulation bed. All patients involved in this study, will participate only previous approval of the informed consent for the study protocol which has been already accepted by the Ethical committee of the Hospital del Salvador.

The inclusion criterion of the patients consists of full-thickness skin wounds, homogeneous granulation tissue and negative bacterial count according to quantitative tissue culture. Exclusion criteria will be based on ages under 18 years or over 65 years. Also, the presence of comorbidities such as hypertension, diabetes mellitus, chronic liver damage, autoimmune diseases, neoplasia, immunosuppression, coronary heart disease, occlusive arterial disease, chronic smoking, drug abuse and/or alcohol. Patients with psychiatric disorders that impede decision-making and continue treatment will also be excluded from the treatment, as well as patients suffering from an acute pathology other than the injury or patients with injuries in the face face and neck.

In case of a major complication (uncontrollable pain, sepsis, shock), or at the request of the patient, the DRPM will be removed immediately and the standard treatment will be performed for that type of wound. All patients included in the study will be evaluated for the immune response against DRPM by means of blood count, C-reactive protein (CRP), renal and hepatic profiles, concentration of inflammatory molecules (IL-6, IL-10, MCP-1, IFN-gamma and TNF-alpha), as well as the following circulating immune cells: T lymphocytes (CD25, CD69, CD62L, CD4 and CD8), B lymphocytes (CD27, CD69, CD19 and CD20), NK1.1 cells (CD14) and CD45 RA and CD45-RO cells, at 0, 3 and 6 days after the patient admission and at 3, 17, 20, 23, 36, 90 and 180 days after DRPM implantation.

Additionally, a biopsy punch will be obtained at days 2 and 5 after DRPM implantation, and wound regeneration will be evaluated by quantification of quantification of cellularization (nuclear staining), vacularization (CD31), cell proliferation (Ki67), hypoxia and extracellular matrix deposition (fibronectin and collagen-1). A final survey about the obtained results will be made to all patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group to test safety of the treatment
Masking: None (Open Label)
Masking Description: There will be no masking of the treatment for researchers
Primary Purpose: Device Feasibility
Official Title: Safety Use of Photosynthetic Dermal Scaffolds for the Treatment of Acute Wounds
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient group
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
Patients with clean wound will receive DRPM over the lesion which will be illuminated by a LEDs array device.




Primary Outcome Measures :
  1. Wound histological status prior to DRPM [ Time Frame: 7 days ]
    Measure of cellularization (nuclear staining), vascularization (CD31), cell proliferation (Ki67), hypoxia, and extracellular matrix deposition (fibronectin and collagen-1) in skin punch biopsy

  2. Wound histological status after to DRPM [ Time Frame: 30 days ]
    Measure of cellularization (nuclear staining), vascularization (CD31), cell proliferation (Ki67), hypoxia, and extracellular matrix deposition (fibronectin and collagen-1) in skin punch biopsy

  3. Circulating blood status prior to DRPM [ Time Frame: 7 days ]
    Measure of blood count, CRP, renal function, hepatic profile and concentration of inflammatory molecules (IL-6, IL-10, MCP-1, IFN-gamma and TNF-alpha) as well as the following immune cells: T lymphocytes (CD25, CD69, CD62L, CD4 and CD8), B lymphocytes (CD27, CD69, CD19 and CD20), NK1.1 cells (CD14) and CD45 RA and CD45-RO cells.

  4. Circulating blood status after to DRPM [ Time Frame: 30 days ]
    Measure of blood count, CRP, renal function, hepatic profile and concentration of inflammatory molecules (IL-6, IL-10, MCP-1, IFN-gamma and TNF-alpha) as well as the following immune cells: T lymphocytes (CD25, CD69, CD62L, CD4 and CD8), B lymphocytes (CD27, CD69, CD19 and CD20), NK1.1 cells (CD14) and CD45 RA and CD45-RO cells.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients hospitalized in the Plastic Surgery Service (Hospital del Salvador)
  • Full-thickness skin wounds.
  • Between 18 and 65 years old
  • Without comorbidities
  • 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.

Exclusion Criteria:

  • Ages under 18 years or older than 65 years.
  • Comorbidities such as hypertension, diabetes mellitus, chronic liver damage, autoimmune diseases, neoplasia, immunosuppression, coronary heart disease, occlusive arterial disease.
  • Chronic tobacco, 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.
  • Patients with face and/or neck injuries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960164


Contacts
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Contact: Juan Camacho, Physician +56978786437 jpcamachomartino@gmail.com
Contact: Miguel Obaid, Physician +56978528623 miguel.obaid.g@gmail.com

Locations
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Chile
Hospital del Salvador Recruiting
Santiago, RM, Chile, 7500787
Contact: Juan Camacho, Physician    +56978786437    jpcamachomartino@gmail.com   
Contact: Miguel Obaid, Physician    +56978528623    miguel.obaid.g@gmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Hospital del Salvador
SymbiOx Inc.
Investigators
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Principal Investigator: Tomas Egaña, PhD. Pontificia Universidad Catolica de Chile
Study Chair: Antonio Eblen-Zajjur, MD., PhD. Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03960164     History of Changes
Other Study ID Numbers: SymbiOx
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pontificia Universidad Catolica de Chile:
Acute skin lesion
Chronic skin ulcer
Traumatic skin lesion
Photosynthetic matrix
Photosynthesis induced regeneration
Tissue regeneration