Clinical Studies – Flowkeepers

Swelling Reduction

Ten volunteers with ankle edema of various etiologies were studied at baseline and after wearing FlowKeepers for 12-24 hours. Five participants had swelling of one leg only, and 5 participants showed bilateral edema. Both limb volumes were evaluated by fluid displacement before and after the stimulation period using FlowKeepers. Both groups of participants showed a statistically significant mean volume reduction (approximately 15% reduction in the bilateral group of participants, and 25% in the unilateral group) – this after wearing the medical device for 12-24 hours, depending on the individual. Researchers concluded that FlowKeepers® is a fast, and potentially very effective method of reducing fluid buildup of the legs or ankles.*

Venous Blood Flow

Ten healthy volunteers, ages 28-67 were recruited to affix the FlowKeepers device to their right calf muslce about 2 inches below the knee. A baseline Doppler ultrasound measurement of the central femoral venous blood flow was made with the device inactive. Subsequent measurements were made with the device activated, with the volunteer in various positions. FlowKeepers was shown to significantly increase venous blood flow of the lower extremities, measured by central femoral vein Doppler flow velocity studies, in all positions tested including recumbent, sitting with and without compression, and standing. The average venous flow velocity while wearing FlowKeepers was approximately 5 times more than baseline, in erect position. Increases in flow at ALL positions were improved by statistically significant margins.*

Wound Care

This study was designed to evaluate the effect of FlowKeepers on patients with chronic leg ulcers. People who are sedentary often develop slow-healing wounds or ulcers on their legs due to reduced tissue oxygenation of the feet. A study at the Wound Care Center of Norwalk Hospital in Connecticut showed significant increases in tissue oxygenation levels.* The measurement was determined using transcutaneous oxygen pressure (tcpO2), a non-invasive method that quantifies skin oxygenation. Six participants were enrolled, of which 5 had chronic, leg or foot ulcers. One was a healthy volunteer. Two measurement sites were taken in each person. Following FlowKeepers use for 30 minutes, tcpO2 increased from 34.2 to 47.7 mmHg in the ulceration group, and 45 to 54 mmHg in the healthy volunteers.

Wakefulness and Performance

This study was designed to evaluate wakefulness and performance in the sleep deprived. Performance of pilots, air traffic controllers, key military and security personnel are impacted by sleep deprivation. Driver sleepiness is a causative factor in 30% of all U.S. motor vehicle crashes and 21% of fatal crashes. Certain factors increase sleepiness such as diminished sensory input and increased splanchnic circulation. Thus, providing sensory stimulation and enhanced peripheral circulation and venous return, might help fight sleepiness. FlowKeepers® was found to help maintain wakefulness and improve performance in healthy, sleep deprived individuals.* We surmise the benefit may be related to ongoing sensory and motor activation, along with enhanced peripheral circulation.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.