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

NCT04460612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-07-14

No results posted yet for this study

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

Interventions

DEVICE

Active IR sock

Subjects will be wearing the infrared socks for 60 minutes

OTHER

Placebo socks

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

Sponsors & Collaborators

  • CIRCUFIBER, Inc.

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Adam B Mayerson, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2022-07-12
Completion
2022-07-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460612 on ClinicalTrials.gov