N/A
N=12
A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
Recessive Dystrophic Epidermolysis Bullosa
Bottom Line
View on ClinicalTrials.gov: NCT05944250 ↗Enrolled (actual)
12
Serious AEs
5.0%
Results posted
Sep 2025
Primary outcome: Primary: Number of Wounds With Greater Than 90% Wound Closure at 4 Months — 0; 3 Wounds — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spincare matrix (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Wounds With Greater Than 90% Wound Closure at 4 Months |
0; 3 | 0.21 |
| SECONDARY Adverse Event Profile Characterization |
11; 10; 0; 2; 0; 0 | — |
| SECONDARY Change From Baseline in Wound Pain Scale Score Assessment |
3.143; 2.762; -1.43; -1.52; 0.43; -1.71 | — |
| SECONDARY Change in Wound Itch Scale Score Assessment |
2.86; 2.10; -1.19; -0.71; -0.85; -0.43 | — |
| SECONDARY Number of Wounds That Reach >50% Healing From Baseline Per Investigator Assessment |
8; 7; 4; 5; 4; 4 | 1 |
| SECONDARY Number of Wounds That Reach >70% Healing From Baseline Per Investigator Assessment |
4; 5; 3; 4; 1; 3 | 1 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05944250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.