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

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.

Study Overview

• Status: Completed
• Conditions: Recessive Dystrophic Epidermolysis Bullosa
• Intervention / Treatment: Device: Spincare matrix

Detailed Description

Investigators will aim to recruit a mixture of adult and pediatric patient. However, the first patient that is recruited would be an adult to collect safety and efficacy data before enrolling pediatric patients.

Screening- Patients would be screened over the phone to assess if they meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the patient to review the consent form and sign. Wounds will be assessed to see if they 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 care (at least 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. Reapplication of matrix treatment may be required depending on how well the matrix has propagated. 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 patient's standard of care, non-adhesive bandage applied. Subjects and caregivers will be trained on how take photos. The aim is to capture photos of the wounds, pain and itch scores at least every 2 weeks. Surveys will be completed by the caregiver to see if they notice any difference in the wounds with the spray treatment. This will be completed together with the patient's pain and itch surveys.

Day 1 and optional Day 2- Clinic Visits: A wound examination will be performed in clinic. The investigator will assess the adherence of the matrix, and any adverse events (AEs). Day 2 visit may be necessary at the discretion of the investigators especially if any adverse events have occurred.

Months 1, 2, 3, 4 Visits: clinic attendance for patients with EB may be stressful and inconvenient due to their complex wound pattern and dressing changes. Keeping their safety and dignity as a priority the remaining visits as home visits are conducted with telehealth assessment. This will be done over a secure virtual platform or phone call whereby the assessors will be consulting remotely from a private Stanford based office room. The caregiver will apply the matrix to randomized, treated wounds (up to once a week application is allowed, the date and reason for reapplication is required)(additional interim visits/telehealth assessment and reapplication of matrix treatment may occur at Week 1, Week 2, Week 6, Week 10 and Week 14 or more frequently if deemed necessary). Patients will be asked to record the date each time the Spincare was applied. Photographs will be taken at those timepoints, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the amount of wound burning, pain, or other adverse events will be scored Month 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 caregiver and sent to the investigator. All wound photos will be reviewed via RedCAP. Wound swabs will be collected from treated and untreated wounds prior to spray treatment and at Month 2 and Month 4.

Participants may be offered the choice to complete surveys online and/or upload photos via Stanford RedCap.

Open-Label (Extension) Phase: After the completion of the 4-month randomized phase, patients will choose to enroll in an open Open-Label Phase for an additional 4 months. Investigators will conduct remote monitoring on a monthly basis to assess adverse events and wound healing. Participants will complete surveys regarding their pain and itch, offer updates on their medical history, and provide information about concurrent medications. No blood draws, wound cultures and in person visits will be required during the Open-Label Phase.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Discovery Hall Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical and/or 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Arm; 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 (at least 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.	Device: Spincare matrix; 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.
Other: Open-label Arm (extension); Participants who are eligible and choose to participate, will be enrolled at the 4 month long optional Open-Label Phase. Participant will be allowed to treat previously randomized wounds (treated and control wounds) and new wounds, up to a max of 10 individuals wounds; there won't be control or randomized wounds. Participants might reapply up to once a week, and wound healing and safety will be assessed at the monthly visits.	Device: Spincare matrix; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Wounds With Greater Than 90% Wound Closure at 4 Months	The primary endpoint was comparison of the duration of wound closure of matrix-treated wounds vs control wounds measured as the number of wounds achieving greater than 90% wound closure within 4 months	Baseline to month 4 of the randomized phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Profile Characterization	Comparison of application site adverse events (burning, erythema, pain) between matrix-treated wounds vs control wounds after application. For this outcome, adverse events were collected per wound; events affecting the participant but not the wound are not included.	4-month randomized period followed by 4-month open-label period
Change From Baseline in Wound Pain Scale Score Assessment	Pain was assessed using the Wong-Baker Faces scale (prior to matrix application). The scale consists of six faces that range from 0 (no pain at all, favorable outcome) to 10 (worst pain imaginable, worst outcome). Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score range of 0 (no pain at all) to 10 (worst pain imaginable).	months 1, 2, 3, and 4 of the randomized phase
Change in Wound Itch Scale Score Assessment	Wound itch scores were assessed using the Itch NRS (prior to matrix application). The Itch NRS is a numerical rating scale from 0 to 10. Participants rated each wound using this scale, and scores were summed and averaged for each time point, resulting in an overall score of 0 to 10 (higher scores correspond to more pain).	months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment	Comparison of wounds that reach >50% healing from baseline in matrix vs control (standard-of-care treated) wounds, per clinician assessment.	months 1, 2, 3, and 4 of the randomized phase
Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment	Comparison of wounds that reach >70% healing from baseline in matrix-treated vs control wounds, per clinician assessment.	months 1, 2, 3, and 4 of the randomized phase

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	months 3 and 4
wound microflora assessment	comparison of change in wound cultures between matrix treated wounds vs control wounds	months 2 and 4

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jean Y Tang, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Congenital Abnormalities; Skin Diseases, Genetic; Skin Abnormalities; Skin Diseases, Vesiculobullous; Collagen Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
• Other Study ID Numbers: 69575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No