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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT04006392
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older. Significant spontaneous pain of 50 or greater on the 0-100 VAS for the feet overall.
* Existing clinical diagnosis of diabetes induced Peripheral Neuropathy.
* Significant spontaneous foot pain that occurs comparably bilaterally.
* Foot pain is chronic, ongoing for at least 3 months, bilaterally.
* Subject has been on a stable anti-diabetic medication regimen or on no anti-diabetic medication regimen for the prior 30 days.
* Subject has not used or is willing to abstain from using analgesics within 7 days prior to study start.
* Subject has been on a stable dosage of antidepressants for at least 90 days prior to study start and is willing and able to maintain that stable dosage throughout study participation OR subject has not used or is willing to abstain from using antidepressants for 30 days prior to study start.
* Subject has been on a stable dosage of any of Neurontin, Lyrica, Tramadol and Opioid medicines such as Ultram and Ultracet for at least 90 days prior to study start and is willing and able to maintain that stable dosage throughout study participation OR subject has not used or is willing to abstain from using any of the these medications for 30 days prior to study start.
* Subject has not received or is willing to abstain from receiving any injections of local anesthetics such as lidocaine within 30 days prior to study start.
* Subject is able and willing to take over-the-counter Regular Strength Tylenol tablets to manage pain, as needed, throughout the study.
* Subject is willing and able to refrain from consuming any over-the-counter and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout study participation, except for the study-specific pain relief medication of over-the-counter Tylenol.
* Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the study, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
* Can communicate fluently in English and can read and write English sufficiently to comply with the study procedures and complete the information in the Subject Diary.
Exclusion Criteria:
* Subject's foot pain is undiagnosed, or has been diagnosed as being other than, or in addition to, diabetes induced Peripheral Neuropathy.
* Subject's foot pain is unilateral or notably different between the two feet.
* Serious organ disease or other serious primary disease merger.
* Diabetes ketosis, ketoacidosis or severe infection within the past two weeks.
* Current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis, peripheral vascular disease.
* Cancer or treatment for cancer in the past 6 months.
* Surgical intervention to treat diabetic peripheral neuropathy foot pain, including implantation of a pain relief device.
* Active infection, wound, or other external trauma to the areas to be treated with the laser.
* Medical, physical, or other contraindications for, or sensitivity to, light therapy.
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
* Any condition or other variable that in the opinion of the investigator may confound or interfere with the evaluation of the effectiveness of the investigational treatment or otherwise render the subject unable to comply with the requirements of the study protocol.
* Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study.
* Participation in a clinical study or other type of research in the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04006392
Study Brief:
Protocol Section:
NCT04006392