Skin Hydration Sensor for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will validate the diagnostic accuracy of a cutaneous hydration sensor. This sensor will also be evaluated for its feasibility as a point-of-care device for the assessment of hydration status and its potential to guide hydration therapy in patients with sickle cell disease (SCD).
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Is the Skin Hydration Sensor safe for use in humans?
How does the Skin Hydration Sensor treatment for Sickle Cell Disease differ from other treatments?
The Skin Hydration Sensor is unique because it is a noninvasive, wireless device that measures skin hydration and transmits data to a smartphone, unlike traditional treatments that may involve medication or more invasive procedures. This sensor provides a novel way to monitor skin health, which can be particularly useful for managing conditions like Sickle Cell Disease where skin hydration may be a concern.23467
What data supports the effectiveness of the Skin Hydration Sensor treatment for sickle cell disease?
Research suggests that hydration can reduce the severity of sickle cell disease, and the Skin Hydration Sensor could help monitor and manage hydration levels effectively. This is supported by studies showing that better hydration correlates with reduced painful crises in sickle cell patients.89101112
Who Is on the Research Team?
Enrico Novelli, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for individuals aged 12 or older who have been diagnosed with Sickle Cell Disease, including various genotypes like SS, SC, and others. Participants must be able to give legal consent to all study procedures. Those under 12 or currently in other clinical trials for experimental therapies cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants' skin hydration is measured at baseline state of health using the Delfin MoistureMeterEpiD hydration sensor.
Crisis Assessment
Skin hydration, serum osmolality, hyperadhesion, elongation index, point of sickling, and urine osmolality are measured before and after fluid resuscitation therapy during a vaso-occlusive crisis (VOC) or vaso-occlusive episode (VOE).
Follow-up
Participants are monitored for safety and effectiveness after the assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Skin Hydration Sensor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Enrico Novelli
Lead Sponsor
Enrico M Novelli
Lead Sponsor