Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT00573261
Eligibility Criteria:
Inclusion Criteria:
* Outpatients aged 18 years or older
* Meet criteria for diagnosis of diabetic neuropathy
* Average daily pain scores greater than or equal to 4 by Visual Analog Scale
* Ability to give informed consent
* No pregnancy
Exclusion Criteria:
* Patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, PTSD, obsessive compulsive disorder, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts
* Patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. These patients must take the last dose of gabapentin the night before starting the study.
* Patients being non-compliant with diabetic control
* Inability to wear the LifeShirt
* Unable to participate or answer questions using a personal digital assistant input device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00573261
Study Brief:
Protocol Section:
NCT00573261