Status:
WITHDRAWN
Exercise Induced Hypoalgesia Diabetes
Lead Sponsor:
University of Miami
Conditions:
Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this research study is to learn whether different forms of exercise can reduce pain experienced by individuals with painful diabetic peripheral neuropathy.
Eligibility Criteria
Inclusion
- Subjects between the ages of 18 - 65.
- Subjects with confirmed Diabetes Mellitus as defined by the American Diabetes Association (ADA), a glycosylated hemoglobin (HbA1c) of 6.5%, a fasting blood glucose \> 126 mg/dL, or an oral glucose tolerance test \> 200 mg/dL.
- Subjects who have stocking and/or glove distribution neuropathy symptoms as drawn on the painDETECT questionnaire.
- Subjects who have neuropathic pain as defined by a minimum score of 4 or higher on the Douleur Neuropathique en 4 Questions (DN4). In addition, the location of pain must be present within the same region of neuropathy symptoms.
- Subjects who have an ankle brachial index (ABI) between 0.7 and 1.4.
Exclusion
- Subjects who have pain due to some other form of neuropathy (chemo-induced neuropathy, alcohol induced neuropathy, exposure to toxins/chemicals, vitamin b12 deficiency, etc.) assessed via a medical history.
- Subjects with current or history of central nervous system disorders.
- Subjects with resting hypertension (HTN) \>/= 160/90 mmHg or known uncontrolled hypertension, coronary artery disease, heart failure, retinopathy, chronic obstructive pulmonary disease, end-stage renal disease, or current open foot ulcers.
- Subjects who are unable to achieve walking a minimum distance of 400 meters in the six-minute walk test.
- Subjects with Reynaud's disease or cold urticaria.
- All vulnerable populations including adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners, individuals with cognitive impairment.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05296642
Start Date
August 1 2022
End Date
August 31 2023
Last Update
May 25 2022
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136