Piloting Prevention

RFU and DePaul researchers are collaborating to pilot behavioral interventions aimed at increasing physical activity in adults at risk of one of diabetes’ most insidious complications — the foot ulcer.

Patients at risk for diabetic foot ulcer (DFU) face a worrisome choice: to exercise and risk developing difficult-to-heal sores that can lead to amputation, or forego the physical activity that is critical to glycemic control and effective diabetes management.

DFUs threaten quality of life. They can cause a sudden halt in daily activities, which in turn can lead to depression. They’re also expensive to treat. 

A study published in 2014 by the journal Diabetes Care found that DFUs impose a “substantial burden on public and private payers, ranging from $9 to $13 billion in addition to the costs associated with diabetes itself.”

A new Pilot Grant study, funded through the Alliance for Health Sciences between Rosalind Franklin University and DePaul University, is working to empower people at risk for DFU to take control of their health and to discover low-cost strategies to help them exercise safely. 

“The idea is to give them the best possible prevention mechanisms so they don’t develop a wound, while encouraging them in a gradual, controlled manner to increase their physical activity level,” said Ryan Crews, MS, CCRP, a kinesiologist and assistant professor in the Dr. William M. Scholl College of Podiatric Medicine’s Center for Lower Extremity Ambulatory Research (CLEAR).

It’s innovative. It’s contemporary. It’s highly relevant. It’s prevention and treatment at the same time. It could change practice.” ELIZABETH MOXLEY, PhD, RN

“I’m very excited about this study,” said Dr. Moxley, assistant professor in DePaul’s School of Nursing at the RFU campus, who helped develop participant screening and baseline assessment protocols and who will triage patient concerns. “It’s innovative. It’s contemporary. It’s highly relevant. It’s prevention and treatment at the same time. It could change practice.”

Study participants will spend eight weeks learning how to exercise in a safe and gradual way, and how to use technology to access medical and psychological support.

Dr. Schneider, in the College of Health Professions, and Mr. Crews, who discovered they share an interest in diabetes and physical activity, preceded their bid for competitive pilot grant funding with a review paper in an attempt to discover: “What don’t we know about increasing activity in people with DFUs?”

The answer is — a lot.

“We found that the literature largely excludes people with DFUs and/or people with neuropathy,” Dr. Schneider said. “They’re excluded from studies because they’re at greater risk for ulcers; because researchers are hesitant to bring in these high-risk populations.”

People with diabetes who suffer from peripheral neuropathy, which causes weakness, numbness and pain in the extremities, and who, consequently, often live sedentary lifestyles, may develop DFUs after sudden bursts in physical activity, like a day spent shopping at a mall or strolling through a fairground.

“For people with diabetes, exercise is crucial,” Mr. Crews said. “For people with risk factors like loss of sensation or deformity or a history of DFUs, the advice, ‘Just stay off your feet,’ may avoid a wound, but it causes other negative consequences.”

Study participants make four visits to CLEAR for introductory monitoring and education, then stay in touch with the research team via text messaging and online social networking for coaching on behavioral strategies to increase physical activity. Each participant is given a Fitbit fitness tracker, which comes with an attached social network.

Dr. Schneider, an expert in health psychology and the use of novel interventions to increase physical activity, is supervising a psychology graduate student who oversees the study’s social networking and posts key health and study information.

“It will be interesting to see if this technology is feasible for an older population,” Dr. Schneider said. “Our goal is to remove barriers to exercise. People with diabetes face all the usual barriers and also an increased incidence of depression, lack of energy, guilt.”

Evidence-based practices for preventing DFUs are also being employed. Study participants are provided home monitoring devices to check their feet for signs of inflammation and early tissue damage. They’re fitted with good shoes and custom made orthoses that are tailored to the shape of the foot and designed to protect it from pressure.

“We’re measuring the loading profile of the foot prior to initiating any changes in activity levels then sending that data and 3D scans to the start-up we’re working with,” Mr. Crews said. “They will mill the devices based on our data. The idea is to give our people the best possible wound prevention mechanisms and the knowledge and tools to be successful.”

Mr. Crews and Dr. Yalla will also work with DePaul’s Dr. Hwang, who will oversee mobility data transmitted from participants by PAMSys lightweight activity sensors and pocket-sized GPS loggers — fertile ground for additional research.

“We can access activity information not only on walking, but also on sitting, standing and lying down in combination with location data,” Dr. Yalla said.

Dr. Hajela, an expert in designing and implementing gait rehabilitation interventions for people with neurological problems, will supervise treadmill training in the early part of the study and compare the resulting data to Fitbit data from the field. The pilot study, she said, speaks highly of the alliance’s interprofessional, collaborative focus and the kinds of projects it’s putting forward.

“I feel privileged to be part of this team where every member brings in a new perspective,” Dr. Hajela said.

The call is intensifying for interdisciplinary, team-based prevention and management of diabetes and its complications.

“The study of the diabetic foot was, for a long time, neglected,” Mr. Crews said. “It’s finally getting more notice and we’re moving toward the prevention of pedal complications associated with diabetes.

“While there’s definitely more money in treating complications, we now understand the awful cost of treating those complications.”

This story first appeared in the Spring 2016 issue of Helix Magazine.