Clinical trial NCT05944250: A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
Official title: A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recessive Dystrophic Epidermolysis Bullosa
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-patient randomization of wound pairs into control wounds vs matrix treated wounds, followed by an open-label (extension) phase without randomization
Primary purpose: TREATMENT

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.

Detailed description: Investigators will aim to recruit a mixture of adult and pediatric patient. However, the first patient that is recruited would be an adult to collect safety and efficacy data before enrolling pediatric patients.

Screening- Patients would be screened over the phone to assess if they meet the inclusion and exclusion criteria. Thereafter a virtual meeting via a secure virtual platform is arranged for the patient to review the consent form and sign. Wounds will be assessed to see if they meet the inclusion and exclusion criteria.

Day 0 - 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 care (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. Reapplication of matrix treatment may be required depending on how well the matrix has propagated. At the time of matrix application, the investigator will score amount of wound burning, pain, or other adverse events. Non-treated wounds will have the patient's standard of care, non-adhesive bandage applied. Subjects and caregivers will be trained on how take photos. The aim is to capture photos of the wounds, pain and itch scores at least every 2 weeks. Surveys will be completed by the caregiver to see if they notice any difference in the wounds with the spray treatment. This will be completed together with the patient's pain and itch surveys.

Day 1 and optional Day 2- Clinic Visits: A wound examination will be performed in clinic. The investigator will assess the adherence of the matrix, and any adverse events (AEs). Day 2 visit may be necessary at the discretion of the investigators especially if any adverse events have occurred.

Months 1, 2, 3, 4 Visits: clinic attendance for patients with EB may be stressful and inconvenient due to their complex wound pattern and dressing changes. Keeping their safety and dignity as a priority the remaining visits as home visits are conducted with telehealth assessment. This will be done over a secure virtual platform or phone call whereby the assessors will be consulting remotely from a private Stanford based office room. The caregiver will apply the matrix to randomized, treated wounds (up to once a week application is allowed, the date and reason for reapplication is required)(additional interim visits/telehealth assessment and reapplication of matrix treatment may occur at Week 1, Week 2, Week 6, Week 10 and Week 14 or more frequently if deemed necessary). Patients will be asked to record the date each time the Spincare was applied. Photographs will be taken at those timepoints, and investigators will use Telehealth to monitor for healing and safety reporting (additional weekly photographs are encouraged). At the time of matrix application, the amount of wound burning, pain, or other adverse events will be scored Month 4 Telehealth/End of study Visit: The investigator will virtually assess wound healing compared to baseline photographs in the treated and control wounds. Digital photographs of the treatment and control wounds will be taken with a ruler by the caregiver and sent to the investigator. All wound photos will be reviewed via RedCAP. Wound swabs will be collected from treated and untreated wounds prior to spray treatment and at Month 2 and Month 4.

Participants may be offered the choice to complete surveys online and/or upload photos via Stanford RedCap.

Open-Label (Extension) Phase: After the completion of the 4-month randomized phase, patients will choose to enroll in an open Open-Label Phase for an additional 4 months. Investigators will conduct remote monitoring on a monthly basis to assess adverse events and wound healing. Participants will complete surveys regarding their pain and itch, offer updates on their medical history, and provide information about concurrent medications. No blood draws, wound cultures and in person visits will be required during the Open-Label Phase.

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

Primary outcomes:
measure: duration of wound closure
timeFrame: Month 4 of the randomized phase
Secondary outcomes:
measure: adverse event profile characterization
timeFrame: Month 4 of the randomized phase
measure: wound pain assessment
timeFrame: months 1, 2, 3, and 4 of the randomized phase
measure: wound itch assessment
timeFrame: months 1, 2, 3, and 4 of the randomized phase
measure: wounds that reach >50% healing from baseline per investigator assessment
timeFrame: months 1, 2, 3, and 4 of the randomized phase
measure: wounds that reach >70% healing from baseline per investigator assessment
timeFrame: months 1, 2, 3, and 4 of the randomized phase
Other outcomes:
measure: caregiver response assessment
timeFrame: months 3 and 4
measure: wound microflora assessment
timeFrame: months 2 and 4
Locations:
city: Redwood City
country: United States
facility: Discovery Hall Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jean Y Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: