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

NCT04460612 | Completed

• 1 other identifier: 2000027079
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in oxygenation of feet and lower legs

  Transcutaneous oxygen measurements will be compared between placebo and active IR sock

  60 minutes

Study Arms (2)

Placebo Sock

PLACEBO COMPARATOR

Placebo Socks will be placed on participants feet either first or second for 60 minutes

Device: Active IR sock; Other: Placebo socks

Active IR Sock

ACTIVE COMPARATOR

Active IR socks will be placed on participants feet either first or second

Device: Active IR sock; Other: Placebo socks

Interventions

Active IR sock DEVICE

Subjects will be wearing the infrared socks for 60 minutes

Also known as: Infrared sock

Active IR Sock; Placebo Sock

Placebo socks OTHER

Placebo Socks will be placed on participants feet first for 60 minute

Active IR Sock; Placebo Sock

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Yale University: lead
• CIRCUFIBER, Inc.: collaborator

Study Sites (1)

Endocrine Associates Of Connecticut

Hamden, Connecticut, 06517, United States

Location

Related Publications (10)

• Shui S, Wang X, Chiang JY, Zheng L. Far-infrared therapy for cardiovascular, autoimmune, and other chronic health problems: A systematic review. Exp Biol Med (Maywood). 2015 Oct;240(10):1257-65. doi: 10.1177/1535370215573391. Epub 2015 Feb 25.

  PMID: 25716016 BACKGROUND

• Vatansever F, Hamblin MR. Far infrared radiation (FIR): its biological effects and medical applications. Photonics Lasers Med. 2012 Nov 1;4:255-266. doi: 10.1515/plm-2012-0034.

  PMID: 23833705 BACKGROUND

• Lin CC, Chang CF, Lai MY, Chen TW, Lee PC, Yang WC. Far-infrared therapy: a novel treatment to improve access blood flow and unassisted patency of arteriovenous fistula in hemodialysis patients. J Am Soc Nephrol. 2007 Mar;18(3):985-92. doi: 10.1681/ASN.2006050534. Epub 2007 Jan 31.

  PMID: 17267744 BACKGROUND

• Ise N, Katsuura T, Kikuchi Y, Miwa E. Effect of far-infrared radiation on forearm skin blood flow. Ann Physiol Anthropol. 1987 Jan;6(1):31-2. doi: 10.2114/ahs1983.6.31. No abstract available.

  PMID: 3675759 BACKGROUND

• Rowley WR, Bezold C, Arikan Y, Byrne E, Krohe S. Diabetes 2030: Insights from Yesterday, Today, and Future Trends. Popul Health Manag. 2017 Feb;20(1):6-12. doi: 10.1089/pop.2015.0181. Epub 2016 Apr 28.

  PMID: 27124621 BACKGROUND

• Geiss LS, Li Y, Hora I, Albright A, Rolka D, Gregg EW. Resurgence of Diabetes-Related Nontraumatic Lower-Extremity Amputation in the Young and Middle-Aged Adult U.S. Population. Diabetes Care. 2019 Jan;42(1):50-54. doi: 10.2337/dc18-1380. Epub 2018 Nov 8.

  PMID: 30409811 BACKGROUND

• Trinks TP, Blake DF, Young DA, Thistlethwaite K, Vangaveti VN. Transcutaneous oximetry measurements of the leg: comparing different measuring equipment and establishing values in healthy young adults. Diving Hyperb Med. 2017 Jun;47(2):82-87. doi: 10.28920/dhm47.2.82-87.

  PMID: 28641320 BACKGROUND

• Zimny S, Dessel F, Ehren M, Pfohl M, Schatz H. Early detection of microcirculatory impairment in diabetic patients with foot at risk. Diabetes Care. 2001 Oct;24(10):1810-4. doi: 10.2337/diacare.24.10.1810.

  PMID: 11574447 BACKGROUND

• International Commission on Non-Ionizing Radiation Protection (ICNIRP). ICNIRP statement on far infrared radiation exposure. Health Phys. 2006 Dec;91(6):630-45. doi: 10.1097/01.HP.0000240533.50224.65. No abstract available.

  PMID: 17099407 BACKGROUND

• McClue G, Celliant Study of Thirteen (13) Healthy Subjects. 2005 (unpublished) https://celliant.com/wp-content/uploads/2020/04/Celliant-Published-Studies-Compilation-of-Clinical-Technical-and-Physical-Trials-April-2020-min.pdf

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adam B Mayerson, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Infrared wraps will be compared to non-infrared placebo wraps which are identical in appearance.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blind Randomized Placebo Controlled using the patients as their own controls. Patients will be randomized to receive either placebo wraps or the infrared wraps and then crossover to the alternative wrap.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: May 26, 2021
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)