A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
A legfontosabb adatok
- Ki végzi
- Stanford University
- Hol
- Redwood City (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 6 fő vett részt
- Kezdés
- 2023. szept. 19.
- Befejezés
- 2024. aug. 14.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Spincare matrix
- A regiszteradat frissítve
- 2025. szeptember 15.
Ki vehet részt
- Életkor
- 6 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- Wounds that have been treated with investigational therapies in the past 3 months
- Actively infected wounds with pus (colonized wounds are eligible)
- Wounds that have had squamous cell carcinoma (SCC)
- Wounds on the face and genitals
Helyszínek itt: Egyesült Államok
- Discovery Hall Stanford UniversityRedwood City, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Randomized ArmA vizsgált kezelés
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.
Kezelés: Spincare matrix
- Open-label Arm (extension)Egyéb csoport
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.
Kezelés: Spincare matrix
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2025. szeptember 15.