Status:
COMPLETED
Infrared Wraps Effect on Oxygenation of Diabetics Arm, Feet and Lower Leg
Lead Sponsor:
Yale University
Collaborating Sponsors:
CIRCUFIBER, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study seeks to prove that wraps manufactured with infrared textile are capable of augmenting peripheral circulation in the lower legs, arm and feet of participants with Diabetes Mellitus. Infrare...
Detailed Description
Infrared energy is a type of electromagnetic energy that is invisible, and is further subdivided into three subsets based on wavelength. Far infrared (FIR or IR-C) is a subset of energy in the infrare...
Eligibility Criteria
Inclusion
- Patient with Type 1 or Type 2 Diabetes Mellitus between the ages of 18 and 80 years old.
Exclusion
- Chronic kidney disease treated by dialysis or those with a eGFR\<30 mL/min/1.73m2
- Alcohol or any illicit substance abuse
- Use of systemic corticosteroids within previous 3 months
- Has ever received immunosuppressive agents
- Has ever undergone radiation therapy
- Has ever used cytotoxic agents
- Pregnant, breast-feeding or attempting to become pregnant
- History of known peripheral arterial disease or lower extremity amputation
- Any neurologic disease or other condition preventing normal ambulation
- History of significant trauma to the lower extremities, major orthopedic or neurological damage to the lower extremities
- History of saphenous venous graft harvesting
- Ankle-Brachial Index of 0.40 or lower
- Any ulcer or open wound on the lower extremities
- Inability to lie flat for up to 90 minutes at a time
- Any symptoms within past 21 days of cough, fever, sore throat, chills, body aches, shortness of breath, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit
- COVID positive nasal swab within past 21 days
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04460612
Start Date
May 26 2021
End Date
July 12 2022
Last Update
July 14 2022
Active Locations (1)
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1
Endocrine Associates Of Connecticut
Hamden, Connecticut, United States, 06517