Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study

Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes.
While most of these ulcers can be treated successfully, some will persist and become
infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic
ulcers will require amputation of the affected limb, resulting in staggering costs for both
the patient and the healthcare system. Prevention by identifying people at higher risk is key
for better clinical management of such patients. It is not uncommon for patients suffering
from diabetes to have concomitant lower extremity edema or venous insufficiency and they
subsequently may benefit from graduated compression. However, because of the common
association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians
are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and
possibility of gangrene.

A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot
Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The
device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and
offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back
to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The
offloading boot design holds the foot and lower leg in a position that reduces shear and
friction forces and provides a reduction in plantar pressure.

The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This
data will be downloaded at each clinic visit. The boot cannot pump blood around the
participant's foot unless fitted correctly and the battery is charged up overnight.

The purpose of this study is to conduct an interventional study study with N=15 diabetic
subjects with active foot ulcers to assess whether PulseFlow foot compression device can help
improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of
gait.

The key goals of the proposed project are to test whether a specially designed compression
device can improve lower extremity perfusion, whilst also simultaneously improving the
balance and walking performance. Investigators envision the use of this specially designed
offloading device with compression capability will help reduce the incidence of diabetic foot
ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device
might enhance daily physical activity as well as walking performance. Investigators will
conduct a prospective clinical study to validate these hypotheses. Potential changes in
walking and spontaneous daily physical activities will be assessed using validated
technologies that include walking analyzer system, balance assessment using body worn
sensors, and computerized pressure insoles.