Results of Our Quality of Life Study

Circufiber, Inc. in partnership with Matthew Capozzi, DPM, D.ABFAS, FACFAS, CWS conducted a pilot survey for a novel sock for the diabetic patient.

INTRODUCTION

Nearly one in ten Americans has been diagnosed with Diabetes Mellitus (DM) and another 96 million US citizens have pre-diabetes. In the United States each year more than a million new cases are diagnosed. A significant amount of DM patients develops poor circulation to their feet and lower legs as well as loss of sensation to the feet (neuropathy). Losing the 'gift of pain' can lead to infections in the feet and ultimately amputation or even death. Preventing foot and lower leg problems is paramount for the treatment of patients with DM. Frequent visits to the podiatrist are vital to discover even a small cut on the foot becomes worse, such as an infection. At a podiatry visit preventative measures are imparted on the patient, including what foot problems to look out for, proper shoe gear, when to call for an emergency and generalized good foot health. In the past DM patients have had no standard sock option to wear that were recommended by a podiatrist. Wearing socks daily should be automatic for a DM patient. Socks prevent blister formation, wick away moisture from the foot, keep the foot warm and provide a protective barrier from dirt and bacteria. Circufiber socks are attempting to disrupt the DM sock world. Circulight® IR technology is a proprietary blend of thermo-reactive minerals that when incorporated into the socks work with the body's energy to produce healing infrared light. The human body naturally emits heat. Circulight® IR technology absorbs this heat and re-emits back into the body in the form of infrared light. Tissues and cells absorb the infrared light, triggering the release of Nitric Oxide (NO) and the natural process of vasodilation. The minerals are woven into the socks so the Circulight® IR won't wash out or wear out, giving the user the same benefits each time.


OBJECTIVE

The survey sought to determine the overall patient satisfaction and product efficacy (for the treatment/relief of pre survey symptoms) of the Circufiber All Day diabetic socks compared to regular socks when worn daily.


METHODS

To test the effectiveness of The Circufiber socks they were distributed to people living with type 2 diabetes to participate in a 6-week Quality of Life Survey. The subjects were recruited throughout the United States with the majority living in the Northeastern part of the country. The survey required people to wear Circufiber All Day diabetic socks for a minimum of 6 hours each day for 6 consecutive weeks. Participants were asked to complete a weekly questionnaire reporting on their experience wearing Circufiber socks. Participants received 7 pairs of Circufiber All Day diabetic socks in a variety of styles/heights for the study and kept the socks at the conclusion of the study. Each participant who successfully completed the 6-week study received a $50 Visa Gift Card and was eligible for a drawing for a $500 Apple Gift Card. Participants’ names, personal information and specific responses were kept strictly confidential. Individual data was only used with the expressed consent of the participating individual. There were strict eligibility requirements to participate in the survey. Each subject had to be at least 18 years of age and a resident of the United States or its territories. They must currently be living with some stage of type 2 DM and they had to be free from foot and/or lower leg skin ulcers/sores. Lastly, they must not be affiliated with Circufiber Inc. or employed by any of its official partners (YaleUniversity, TH Mills). The study was performed at two different times of the year. Group 1 began in November 2021 and finished in February 2022. A total of 32 people completed the survey. Group 2 started the study in February 2022 and completed in April 2022 where 48 people completed the study. In all, 80 people fulfilled all the obligations to successfully complete the study.


RESULTS

97% of the users stated they noticed benefits or improvements in their feet by wearing the Circufiber All Day diabetic socks. 91% agreed they would like to continue wearing the socks in the future and that they were more likely to exercise while wearing the socks. Foot conditions showed improvement to multiple issues including cold toes (63%), foot swelling (47%), pain (57%) and pins and needles (46%). 83% said wearing the socks inspires them to make healthier choices and 99% said they would recommend the socks to others. The participants were asked what type of foot/ankle conditions that bother them. The most common answers were foot/ankle swelling, cold toes, generalized foot pain, pins and needles and arch pain. 85% of the subjects noticed improvements in their foot/leg problems within the first 2 weeks of wearing the socks and 97% were less symptomatic overall.

DISCUSSION

The results of the survey were overwhelmingly positive. Knowing that a diabetic patient using the Circufiber socks would be more likely to exercise and make healthier life choices is what stands out to me. The goal as a medical professional is to aid patients to live a happy, healthy life while managing any chronic condition. We have seen that living a normal life with DM is possible with good medical care, diet, and exercise. If Circufiber socks can in any way improve lifestyle changes while at the same time improving foot and ankle symptoms, then it should become well known in the diabetic sock world. A trial is being done at Yale University by Dr. Adam Myerson, MD to assess the oxygenation of tissue when using the Circufiber socks. The study is very promising for Circufiber.

In my practice I have had roughly 25 patients give feedback on the socks. The results have been nothing but positive with most saying their feet have never felt better. I have also noticed improvement in dry skin to the feet along with less symptomatic Raynaud's phenomenon. Having few options to offer my patients with regards to sock wear, Circufiber is starting to become part of my office protocol for my diabetic patients to help with foot problems. Socks are something my patients should be wearing daily and if they can have added benefit of symptom improvement, in a safe way, then I believe Circufiber socks will soon be synonymous with diabetic socks.


CONCLUSION

Data suggests significant patient satisfaction using the Circufiber socks. Currently a study is concluding at Yale University measuring the tissue oxygenation levels when using the Circufiber socks versus a placebo. More scientific studies may be valuable in the future. Possible randomized trials with Circufiber socks vs placebo, incidence of ulcer formation while wearing Circufiber socks compared to placebo and more in-depth quality of life studies would help. There could also be applications for the Circufiber socks in post-operative edema treatment or even wound care. All in all, the initial response from the user has been positive and encouraging for further uses and research.


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