Acute COVID-19, Diabetic Neuropathy, Long COVID-19, Postural Orthostatic Tachycardia Syndrome (POTS)
Conditions
Keywords
COVID, Diabetic Neuropathy, Postural orthostatic tachycardia syndrome, POTS
Brief summary
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system.
Detailed description
This is a prospective, longitudinal study involving 300 participants for a single visit to compare Long COVID-19 neurocutaneous biosignatures with those of other disorders affecting the sensory and autonomic nervous system. The evaluations will include clinical assessments, neurologic exams, patient reported outcome surveys, and skin biopsies from three locations. Data will be collected on the amount of P-SYN in cutaneous nerve fibers. The cohorts of interest are as follows: 1. 100 participants with Long COVID-19 defined by NIH PASC criteria 2. 100 participants with acute COVID-19 who tested positive for COVID-19 without persistent symptoms defined WHO criteria 3. 50 participants with postural orthostatic tachycardia syndrome (POTS) 4. 50 participants with diabetic neuropathy There are no plans for additional visits at this time. If interested to learn more about this study, please complete the form here for someone to contact you. "here" would take you to the said form.
Interventions
None listed
Sponsors
CND Life Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
, just one of the following: * Long COVID-19 defined by NIH PASC criteria OR * Acute COVID-19 who tested positive for COVID-19 without persistent symptoms OR * Postural orthostatic tachycardia syndrome (POTS) OR * Diabetic neuropathy
Exclusion criteria
* Clinical evidence of severe peripheral vascular disease * History of ulceration, poor wound healing or vascular claudication * History of allergic reaction to local anesthesia (for biopsy collection) * Use of oral anticoagulants (aspirin or Plavix alone is allowed) * History of a bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes | Current - December 31,2025 | This is a single site study of subjects with Long COVID, subject with a previous positive COVID test without persistent symptoms, and POTS subjects and diabetics. Neurocutaneous biosignatures will provide insight into the pathology and nervous system changes that occur in patients suffering from sensory and autonomic function changes. |
Countries
United States
Outcome results
None listed