Infrared Wraps Effect on Oxygenation of Diabetics Arm, Feet and Lower Leg

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes

In brief

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. Infrared is currently used in saunas and various textiles as general wellness products that purport to improve various health conditions and augment microcirculation. This study is intended to investigate specifically whether wraps capable of harnessing infrared energy can improve oxygenation in the feet, arms and lower legs of diabetics using noninvasive transcutaneous oximetry to do so.

Key facts

Study ID

NCT04460612

Run by

Yale University

People needed

39

Starts

2021-05-26

Expected to finish

2022-07-12

Last updated by the study team

2022-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with Type 1 or Type 2 Diabetes Mellitus between the ages of 18 and 80 years old.

You may not qualify if…

• 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

Where it is running

• Endocrine Associates Of Connecticut — Hamden, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.