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A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients (RDEB)

Primary Purpose

Recessive Dystrophic Epidermolysis Bullosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spincare matrix
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recessive Dystrophic Epidermolysis Bullosa

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical and genetic diagnosis of RDEB by a dermatologist Age 6 years or older willing and able to give consent/assent At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin) Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks) Exclusion Criteria: Actively infected wounds with pus (colonized wounds are eligible) Wounds that have had squamous cell carcinoma (SCC) Wounds on the face and genitals Wounds that have been treated with investigational therapies in the past 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control wound

    matrix treated wounds

    Arm Description

    standard of care dressing and bandages

    wounds treated with Spincare matrix device at monthly intervals or as required at the discretion of the principal investigator

    Outcomes

    Primary Outcome Measures

    duration of wound closure
    comparison of the duration of wound closure (weeks) of matrix treated wounds vs control wounds from baseline to Month 4

    Secondary Outcome Measures

    adverse event profile characterization
    comparison of application site adverse events (burning, erythema, pain) between matrix treated wounds vs control wounds after application
    wound pain assessment
    comparison of wound pain (Wong-Baker Faces scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The scale consists of six faces that range from no pain at all (favorable outcome) to the worst pain imaginable (worst outcome)
    wound itch assessment
    comparison of wound itch (Itch Man scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The Itch Man scale is used to rate itching intensity and ranges from 0- comfortable, no itch (favorable outcome) to 4- itches most terribly, impossible to sit still, concentrate (worst outcome)
    caregiver response assessment
    comparison of patient and caregiver responses on wound dressing ease of use on matrix treated wounds vs control wounds with the Caregiver Global Impression of Change survey (CrGI).
    wound microflora assessment
    comparison of change in wound cultures between matrix treated wounds vs control wounds at 4 months.

    Full Information

    First Posted
    July 5, 2023
    Last Updated
    July 12, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05944250
    Brief Title
    A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
    Acronym
    RDEB
    Official Title
    A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin. The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing. The aim of this study is to determine the suitability of this device in RDEB wounds and assess its wound healing properties, safety and tolerability.
    Detailed Description
    Investigators will aim to recruit a mixture of adult and pediatric participants. However, the first participant that investigators would recruit would be an adult to ensure investigators have safety and efficacy data before enrolling pediatric participants. Screening- Participants would be screened over the phone to assess if participants meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the participant to review the consent form and sign. Wounds will be assessed to see if participants meet the inclusion and exclusion criteria. Day 0 - A full body wound examination will be performed by the investigator and target wound areas will be marked. All eligible wound sites will be randomized for matrix treatment versus standard of care wound dressings (6 wounds, or 3 wound pairs). The matrix will be applied to randomized treatment wounds, along with a non-adhesive bandage as a protective layer. At the time of matrix application, the investigator will score amount of wound burning, pain, or other adverse events. Non-treated wounds will have the participant's standard of care, non-adhesive bandage applied. Participants and caregivers will be trained on how to use the DORA (RedCAP enabled photo capture system that is PHI compliant). Investigators will aim to capture photos of the wounds using this application weekly. Wound pain and itch are also captured weekly in the app. Day 1 and 2- Clinic Visits: A wound examination will be performed in clinic. Reapplication of matrix treatment may be required depending on how well the matrix has propagated . The investigator will assess the adherence of the matrix, and any adverse events (AEs). Months 1, 2, 3, 4 Home-nurse Visits: Clinic attendance for participants with EB may be stressful and inconvenient due to complex wound pattern and dressing changes. Keeping safety and dignity as a priority investigators will conduct the remaining visits as home nurse visits with telehealth assessments. This will be done over a secure virtual platform whereby the investigators will be consulting remotely from a private Stanford based office room. A home nurse will travel to the participants home to apply the matrix to randomized, treated wounds once a month (additional interim home visits/telehealth assessment and reapplication of matrix treatment may occur at Day 14, month 1.5, month 2.5 and month 3.5 if deemed necessary). Photographs will be taken at those timepoints using DORA, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the home-nurse will score amount of wound burning, pain, or other adverse events. Months 4 Telehealth /End of study Visit: The investigator will virtually assess wound healing compared to baseline photographs in the treated and control wounds. Digital photographs of the treatment and control wounds will be taken with a ruler by the home-nurse and sent to the investigator. All wound photos will be reviewed via DORA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recessive Dystrophic Epidermolysis Bullosa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    6 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control wound
    Arm Type
    No Intervention
    Arm Description
    standard of care dressing and bandages
    Arm Title
    matrix treated wounds
    Arm Type
    Experimental
    Arm Description
    wounds treated with Spincare matrix device at monthly intervals or as required at the discretion of the principal investigator
    Intervention Type
    Device
    Intervention Name(s)
    Spincare matrix
    Intervention Description
    The Spincare device, developed by Nanomedic, is the first portable tool that delivers a non-invasive, non-therapeutic electrospun, nanofibrous matrix dressing to wounds to promote healing.
    Primary Outcome Measure Information:
    Title
    duration of wound closure
    Description
    comparison of the duration of wound closure (weeks) of matrix treated wounds vs control wounds from baseline to Month 4
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    adverse event profile characterization
    Description
    comparison of application site adverse events (burning, erythema, pain) between matrix treated wounds vs control wounds after application
    Time Frame
    4 months
    Title
    wound pain assessment
    Description
    comparison of wound pain (Wong-Baker Faces scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The scale consists of six faces that range from no pain at all (favorable outcome) to the worst pain imaginable (worst outcome)
    Time Frame
    4 months
    Title
    wound itch assessment
    Description
    comparison of wound itch (Itch Man scale) between matrix treated wounds vs control wounds at month 1, month 2, month 3, month 4 (prior to application). The Itch Man scale is used to rate itching intensity and ranges from 0- comfortable, no itch (favorable outcome) to 4- itches most terribly, impossible to sit still, concentrate (worst outcome)
    Time Frame
    4 months
    Title
    caregiver response assessment
    Description
    comparison of patient and caregiver responses on wound dressing ease of use on matrix treated wounds vs control wounds with the Caregiver Global Impression of Change survey (CrGI).
    Time Frame
    4 months
    Title
    wound microflora assessment
    Description
    comparison of change in wound cultures between matrix treated wounds vs control wounds at 4 months.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical and genetic diagnosis of RDEB by a dermatologist Age 6 years or older willing and able to give consent/assent At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin) Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks) Exclusion Criteria: Actively infected wounds with pus (colonized wounds are eligible) Wounds that have had squamous cell carcinoma (SCC) Wounds on the face and genitals Wounds that have been treated with investigational therapies in the past 3 months

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified coded data may be shared with collaborators, funding agency and presented at scientific meetings. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) would be shared.
    IPD Sharing Time Frame
    Immediately following publication. No end date
    IPD Sharing Access Criteria
    Data will be presented at scientific meeting and in published material, Data may be available on sponsors website. Alternatively, proposals should be addressed to tangy@stanford.edu. To gain access, data requestors will need to sign a data access agreement.

    Learn more about this trial

    A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients

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