Diabetes frequently leads to decreased sensation in the legs caused by peripheral neuropathy (DPN). DPN is an important risk factor for the development of foot ulceration, one of the most common causes for hospital admissions and lower-limb amputations among diabetic patients. In the United States, diabetes complications are the leading cause of non-traumatic amputations, accounting for 86,000 of them annually. Treatments to improve sensation in DPN patients would decrease the patient's risk for foot ulceration and lower-extremity amputation, and improve the patient's overall prognosis and quality of life. The goal of this research project is to assess the effectiveness of a non-invasive peristaltic pulse pneumatic compression device (PCD) in a home treatment program to improve the symptoms of diabetic peripheral neuropathy (e.g. numbness, pain, and tingling in the legs) and the neurovascular functioning of the nerves in the legs (as determined by nerve conduction testing). Sixty subjects diagnosed with DPN who have abnormal nerve conduction testing will be enrolled in the study following informed consent. Subjects will be randomly placed in one of two groups: a control group using a NormaTec PCD that looks and operates like all the NormaTec PCDs in the study, but that will be adjusted so that no compression is delivered to the leg;and an experimental group who will use an accurately calibrated device that delivers physiologic dynamic compression to the leg. Both the subjects and the research investigators will be unaware of the particular group in which a subject is placed. Each subject will be evaluated monthly for both subjective and objective responses. Subjective matters (e.g. "do you have more sensation in your feet?") will be appraised with a standardized diabetic questionnaire. Objective matters (e.g. "does the subject respond to stimuli in the foot?") will be appraised with measureable non-invasive bedside testing: vibration, soft-touch cotton ball, sharp-touch jagged wooden sticks, and electro-diagnostic testing to measure nerve conduction. When the study concludes, the two groups will be compared statistically to determine if a PCD improves symptoms of DPN. If the study shows that a peristaltic pulse pneumatic compression device can significantly improve DPN symptoms, we anticipate that the device will quickly become standard care for DPN. By so doing, the incidence of extremely costly non-healing diabetic wounds and limb loss can be radically reduced.

Public Health Relevance

Project Narrative Diabetic peripheral neuropathy affects over 7 million Americans, often leading to non-healing wounds and leg amputation. Unfortunately, no effective treatment exists. This study will test an innovative technology that promises to halt and even reverse the symptoms of this devastating condition.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK088634-01
Application #
7928482
Study Section
Special Emphasis Panel (ZRG1-DKUS-E (53))
Program Officer
Jones, Teresa L Z
Project Start
2010-09-30
Project End
2011-08-31
Budget Start
2010-09-30
Budget End
2011-08-31
Support Year
1
Fiscal Year
2010
Total Cost
$199,956
Indirect Cost
Name
Normatec Industries, Lp
Department
Type
DUNS #
111448069
City
Newton
State
MA
Country
United States
Zip Code
02459