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

NCT05944250 | Completed Results FDA Device

• 1 other identifier: 69575
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Recessive Dystrophic Epidermolysis Bullosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adverse Event Profile Characterization

  4-month randomized period followed by 4-month open-label period

• Change From Baseline in Wound Pain Scale Score Assessment

  months 1, 2, 3, and 4 of the randomized phase

• Change in Wound Itch Scale Score Assessment

  months 1, 2, 3, and 4 of the randomized phase

• Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment

  months 1, 2, 3, and 4 of the randomized phase

• Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment

  months 1, 2, 3, and 4 of the randomized phase

Study Arms (2)

Randomized Arm

EXPERIMENTAL

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

Open-label Arm (extension)

OTHER

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

Interventions

Spincare matrix DEVICE

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.

Open-label Arm (extension); Randomized Arm

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Discovery Hall Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous

Results Point of Contact

• Title: Dr. Yuri Ikeda
• Organization: Stanford University

yurikeda@stanford.edu

650-647-3485

Study Officials

• Jean Y Tang, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds, followed by an open-label (extension) phase without randomization

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: September 19, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately following publication. No end date
• 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.

Locations

US (1)