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

Completed · Not applicable

Conditions studied: Recessive Dystrophic Epidermolysis Bullosa

In brief

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.

Key facts

Study ID

NCT05944250

Run by

Stanford University

People needed

6

Starts

2023-09-19

Expected to finish

2024-08-14

Last updated by the study team

2025-09-15

Who can join

Age: 6 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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