The Need:  A Human and Financial Crisis

Diabetic wounds have become a human and financial crisis.  Addressing this crisis has become our initial target.

An estimated 1.5 million Americans have diabetic foot ulcers (DFU).  More than half will become infected and 20% of these will lead to amputation.  Patient survival two years after amputation is 62%; 31% after five years. The estimated US cost of DFU management is $9 billion to $13 billion per year - greater than prostate and breast cancer combined.

The numbers will get worse.  The diabetes epidemic is driven in part by aging and the obesity epidemic, both of which are burgeoning.  Diabetic wounds will grow by 112 percent between 2015 and 2020 from 25+ million Americans to 55 million. 

The current standard of care heals only 25% to 35%. Existing therapies are limited in effectiveness, nonstandard in delivery and can be prohibitively expensive.  Most of them treat symptoms rather than underlying causes. We are developing an alternative.

We Deliver A New Approach to Healing Diabetic Wounds

The cause of chronic diabetic wounds appears to be ischemic damage to tissue, a frequent cause of multiple debilitating diseases and death, including pressure wounds, sepsis and stroke in addition to diabetic wounds.

Ischemia is inadequate blood supply to an organ. It kills cells and damages tissues by depriving them of the oxygen and nutrients they need to stay alive.

A 25-year-old therapy called Remote Ischemic Conditioning (RIC) was developed to protect the body from ischemic damage. It is believed to prompt cellular signaling that releases multiple factors which activate the body’s innate mechanism for healing itself.  RIC is delivered by using a blood pressure cuff and a systematic protocol to induce transient limb ischemia.

A 2015 Journal of the American College of Cardiology article states: “RIC is safe and effective, noninvasive, easily feasible, and inexpensive.”

Our Adjunctive Therapy Application Uses RIC in a New Way to Condition the Body to Heal Chronic Wounds

Our therapy application is Continual Remote Ischemic Conditioning (cRIC).

  • RIC.  Blood flow is systematically blocked and restored for 40 minutes in 4 successive cycles by inflating a blood pressure cuff – just once before or during an acute event with the intention of protecting an organ from possible future damage.

  • Continual RIC.  A systematic protocol repeats the basic RIC process 2-3 times per week for 12 weeks or more after 4 weeks of Standard of Care with the intention of healing a chronic condition and restoring healthy tissue.

Yes, ischemia - inadequate blood flow – stops wounds from healing by depriving tissues of oxygen and nutrients they need to stay alive. But, managed in this way, temporary ischemia helps to activate the body’s self-healing and tissue regeneration.

Two studies have found Continual RIC therapy beneficial for diabetic foot ulcers

Advanced RIC Studies of Diabetic Foot Ulcers:  Shaked

Dr. Gad Shaked, Head of the Trauma Unit at Soroka and Ben Gurion Universities in Beersheba, Israel published a study in February 2015 in Wound Repair and Generation conducted among 40 randomized and single blinded DFU patients.

Dosing:  One group of 24 received standard of care plus 3 RIC therapies 2 weeks apart for 6 weeks. The other group of 16 received the standard of care plus 3 sham therapies two weeks apart for 6 weeks.

Healing Rate:  The Shaked study achieved 41% healing – 9 of the 22 patients who completed the study – vs. none for the 12 patients who completed the sham therapy. 

Advanced RIC Studies of Diabetic Foot Ulcers:  Regulski

Dr. Matthew Regulski, DPM, a principal at Ocean County Foot & Ankle Associates, PC, and Director of the Wound Care Institute of Ocean County, is conducting an ongoing RIC study of diabetic wound patients, sponsored by LifeCuff Technologies, which he started in July 2018.  It differs from the Shaked study in three respects and has had even more positive results:

  1. Dosing.  RIC therapy 2-3 times per week instead of every 2 weeks with the treatment period extended to 12 weeks for all patients, plus up to 8 additional weeks for unhealed patients.

  2. Replaced the sham therapy group with a “matched group” of patients with similar overall health and wound sizes from control groups in past DFU studies at Dr. Regulski’s practice, which showed a 25% 12-week healing rate, consistent with broad averages.

  3. Used a LifeCuff Technologies automated device to deliver consistent therapy on each therapy.

Healing Rate.  As of September 30, 2019, the Regulski study, which is ongoing, had achieved 79% healing for the 20-week period – 23 of 29 patients who completed the study – and 61% healing for the 12-week period – 17 of 29 patients.  In the matched group, the healing rates were 30% for 20 weeks and 25% for 12 weeks.