Clinical Study

The clinical study of the first generation of the LifeCuff device was conducted in a vascular clinic in Ocean County, NJ by Dr. Matthew Regulski. All successive incoming patients with chronic diabetic wounds were included in the study, regardless of their other comorbidities, making this a “real-world” study. Many of the 40 patients included in the study were elderly and had a number of other preexisting conditions and diseases, such as smoking, kidney disease, COPD, etc. There were a total of 41 wounds treated using repeated RIC (rRIC), with one patient having two wounds.

 

Patients were treated 3 times a week for 12 weeks by a visiting nurse applying LifeCuff at their homes. In some cases, the treatment was extended for a total of 20 weeks, based on a recommendation of the treating physician.

 

Matched controls were used to assess the results of the study, using patients from the same clinic matched by the location and the size of the wounds. The matched patients were treated in the few years prior to the study by the same physician using a “standard-of-care” approach.

 

The study showed a strong 2X increase in the healing rate reaching 75% in this difficult-to-treat cohort.