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Procedure

Temporary Skin Substitute for Epidermolysis Bullosa (RDEB Trial)

N/A

Recruiting

Led By Jean Y Tang, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin)

Clinical and genetic diagnosis of RDEB by a dermatologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

RDEB Trial Summary

This trial will assess a device's ability to heal wounds from a rare skin condition called epidermolysis bullosa. The device will be tested for safety, healing properties, and tolerability.

Who is the study for?

This trial is for individuals aged 6 and older with RDEB, a skin condition causing blistering. Participants must have at least six wounds present for over four weeks, which can be classified as recurrent or chronic open. Wounds should not be infected with pus, treated for cancer (SCC), located on the face/genitals, or recently treated with investigational therapies.Check my eligibility

What is being tested?

The study tests Spincare Matrix, a non-invasive skin substitute designed to promote wound healing in patients with RDEB. It uses a portable device that creates an electrospun nanofibrous dressing directly on wounds to assess its effectiveness and safety.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include irritation at the application site, allergic reactions to the matrix material, or no improvement in wound healing.

RDEB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 6 large wounds not on my face or genitals.

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I have been diagnosed with RDEB by a skin doctor.

RDEB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

duration of wound closure

Secondary outcome measures

adverse event profile characterization

caregiver response assessment

wound itch assessment

+2 more

RDEB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: matrix treated woundsExperimental Treatment1 Intervention

wounds treated with Spincare matrix device at monthly intervals or as required at the discretion of the principal investigator

Group II: control woundActive Control1 Intervention

standard of care dressing and bandages

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,344 Total Patients Enrolled

1 Trials studying Dystrophic Epidermolysis Bullosa

Jean Y Tang, PhDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of individuals being treated in this research project?

"Affirmative. The trial is actively enlisting individuals according to the information on clinicaltrials.gov, and was first posted on November 1st 2023 with its most recent update taking place on November 21st of the same year. 6 volunteers are needed from a single site for this study."

Answered by AI

Is there an open call for participants to join this research?

"Affirmative. As per the clinicaltrials.gov database, this trial is still recruiting participants. It was first posted on November 1st 2023 and has been updated recently on 21st of that same month. The research team is seeking 6 individuals across a single medical site for enrollment in the study."

Answered by AI

Who has the necessary qualifications for participation in this trial?

"This medical trial is recruiting 6 persons suffering from dystrophic epidermolysis bullosa, aged between 6 and 65. To be eligible for participation, patients must meet the following prerequisites: Dermatologist-verified clinical and genetic diagnosis of RDEB; willing to give consent/assent at least six years old; sustained minimum three pairs of lesions (each with a surface area larger than 10cm2), that have been present for a period longer than 4 weeks; recurrent wounds or chronic open wounds whose healing does not exceed 12 weeks."

Answered by AI