Infrared Wraps Effect on Oxygenation of Diabetics Arm, Feet and Lower Leg
Condition: Diabetes
Study type: Interventional

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.
    

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 infrared spectrum that is thought to transfer energy in the form of heat,
      perceived by thermoreceptors in the skin as radiant heat. FIR is thought to be both absorbed
      by the human body but is also emitted in the 3-50 micron range, with a peak output at 9.4
      micron. The range of far infrared varies depending on which source is referenced but is
      generally felt to start at 3 to 5 microns. The use of FIR has been studied in various
      circumstances and thought to improve various biological functions via FIR heat lamps, saunas,
      ray devices and FIR emitting ceramics and fabrics. There are no short-term or long-term
      safety issues that have arisen in any studies thus far. As noted in the 2006 statement of the
      ICNIRP (International Commission on Non-Ionizing Radiation Protection), "…the contribution
      made by the IR-C spectral region (3-1,000 micron) is normally of no practical concern from a
      health hazard standpoint." FIR has been shown to increase blood flow in forearms, and access
      flow and survival of arteriovenous fistula in hemodialysis patients. An unpublished study, by
      McClue, reported an apparent increase in pedal circulation of approximately 10% using
      transcutaneous oxygen monitoring in healthy subjects wearing socks infiltrated with FIR
      emitting textiles. The mechanism of improving circulation is not entirely elucidated, however
      recent work suggests a role of increasing endothelial nitric oxide synthase, nitric oxide
      production and modulating profiles of circulating miRNAs (mircoRNA, small noncoding RNAs of
      ∼22nt in length which are involved in the regulation of gene expression at the
      posttranscriptional level).

      Type 2 Diabetes prevalence has increased significantly over the past decade, with estimates
      from 2015 of 26 million Americans diagnosed and predicted to increase to 32 million by 2020.
      Both Type 1 and Type 2 Diabetes is well known to increase the risk of nontraumatic lower
      extremity amputation by, amongst other factors, impairing circulation to the feet through
      both peripheral arterial disease and microvascular dysfunction.

      Noninvasive transcutaneous oximetry measurements of the leg have been validated as a valuable
      tool in assessing lower extremity circulation in both normal subjects and diabetic
      individuals.

      This trial seeks to prove that exposure to IR, through the use of newly developed socks
      (wraps here with same material) that contain thermoreactive particles woven into textile,
      which both emit IR and reflect the IR back from the body, can augment circulation in the
      feet, arms and lower legs of diabetic subjects. Noninvasive transcutaneous oximetry will be
      used as the assessment modality. If this study confirms this hypothesis, future studies may
      be planned to determine if the use of a IR-containing textile can prevent new ulcers from
      forming in high risk patients and perhaps even speed the healing of prevalent foot ulcers.

      Subjects will be recruited from both primary care and specialty medical offices who carry a
      diagnosis of Diabetes Mellitus, will be between the ages of 18 to 80 and will act as their
      own controls. The goal will be to enroll a minimum of one hundred (100) patients who will be
      evaluated noninvasively with transcutaneous oxygen measurements using Radiometer TCM
      (PeriFlux 5000) supplied by Radiometer America, Inc. Upon screening and after signing
      informed consent, patients will have ankle brachial index (ABI) measurements performed on
      both legs to exclude those who have severe peripheral arterial disease (ABI index or 0.4 or
      lower). Upon arrival on study day, subjects will have both feet evaluated by a registered
      nurse (RN), to ensure there are no signs of infection, active foot ulcers, or other open
      wounds. If there is any such evidence, the patients will be excluded from the trial and sent
      for further evaluation and treatment according to standard of care by their primary care
      clinicians or podiatrists.

      Subjects will be placed on an exam table reclined at a 120-degree angle with legs extended
      and supported by leg rest. The TCPO2 machine will have been turned on prior to patient
      arrival for calibration. If necessary, any hair on the subject's foot or leg will be removed
      in the area of fixation ring application by a disposable razor. The subject will then have up
      to 3 fixation rings attached, used for measuring TCPO2, placed on the lower leg and foot. The
      fixation rings will be further secured around the circumference with medical tape,
      approximately 1 inch by 0.5 inch per piece to further enhance the seal. In a double blind
      fashion, subjects will be randomized to have either placebo or IR wraps placed in a
      sequential way. The wrap will be placed over the foot, arm and lower leg covering the
      fixation rings. Three drops of contact solution will be placed inside each fixation ring,
      followed by attachment of the electrodes. There will then be a 30 minute rest/stabilization
      period allowing for the TCPO2 to stabilize (stabilization phase).

      The wraps will then be gently applied to the arm, feet and leg, while being careful not to
      disturb the fixation rings. The placebo wraps are identical in all ways to the study wrap,
      with the exception that the placebo wraps do not contain the proprietary thermoreactive
      minerals woven into the fabric. The active phase will then commence and continue for 60
      minutes, with TCPO2 measurements taking place continuously and recorded at least every 10
      minutes. At the end of the 60-minute study period, the leads will be removed, followed by the
      wraps. The fixation rings are not removed, however. The TCPO2 machine should be recalibrated
      after the leads are returned to the holding chamber, prior to the second half of the trial
      using the other wraps (either IR or placebo, whichever was not used in first session). There
      will then be a 10-minute break period, subjects will be allowed to use the restroom and may
      place loose foot coverings over their feet for ambulation. Following the subjects return to
      the exam table, the same above protocol will be followed, with 30 minutes of
      rest/stabilization after the leads are placed back on for the baseline readings prior to wrap
      placement. Repeat TCPO2 measurements will be obtained according to the same schedule as
      indicated above. Activity will be restricted during the active and stabilization phase of the
      protocol. Patients will be encouraged to void prior to initiation of each half of the
      protocol. However, should subjects have to use the bathroom during one of the active phases,
      the rest and stabilization phase will restart at time zero following the bathroom break and
      reattachment of the TCPO2 sensors. At the completion of the study, the leads and fixation
      rings will be removed and subjects will return placebo and study socks to the appropriate
      personnel.
    

Intervention name(s): Active IR sock; Placebo socks
Intervention type(s): Device; Other
Intervention description(s): Subjects will be wearing the infrared socks for 60 minutes; Placebo Socks will be placed on participants feet first for 60 minute
Other intervention name(s): Infrared sock
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment