CompletedNot Applicable

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

United States6 participantsStarted 2023-09-19

Plain-language 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.

Who can participate

Age range6 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Wounds With Greater Than 90% Wound Closure at 4 Months

Timeframe: Baseline to month 4 of the randomized phase

Trial details

NCT IDNCT05944250

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-14

Results submitted2025-07-15

View on ClinicalTrials.gov More Recessive Dystrophic Epidermolysis Bullosa trials