Veterans with diabetes are at risk for foot ulcers and amputations, particularly if they have neuropathy, vascular disease or anatomic abnormalities, and have poor foot self-care, poor foot self-monitoring and/or nonadherence to diet, medication, and exercise. It is difficult to activate at-risk Veterans to improve self-care and self-monitoring, and lower other amputation risks such as A1c and other risk factors. Proposed is a randomized controlled trial testing the effectiveness of a comprehensive personalized behavioral intervention (PBI) aimed to improve foot self-care, foot self-monitoring, and modifiable risks for amputation such as peripheral vascular disease (PVD), A1c, BP and LDL using behavioral counseling combined with dermal thermometry. The primary specific aim is to evaluate the effect of PBI on the proportion of ulcerative and non-ulcerative lesions compared to current best practice (CBP) in diabetes. The secondary specific aims are to evaluate the impact of PBI on foot self-care skills, foot education and adherence, A1c, BP and LDL, and quality of life at 6 months; its longer-term effects at 12 months on foot care, adherence and risk factors; and cost-effectiveness compared to CBP. We will recruit 404 Veterans with diabetes who are at higher than normal risk of foot ulcers [PAVE score of 1, 2 or 3 (with no history of ulcers or amputations)]. The interventions will be standardized and fidelity of the intervention will be maintained. Using a blinded RCT, we will test the effect of PBI in relation to CBP. Key outcomes are non-ulcerative and ulcerative lesions, foot-care skills, foot care education, adherence to diet and medication, general and foot health-specific quality of life, A1c, BP, and LDL. Outcomes will be measured at baseline, 6 and 12 months. All analyses will be intent-to-treat. This study will evaluate a comprehensive risk-stratified PBI targeting multiple behaviors related to self-care, self-monitoring and amputation risk. This study applies advanced behavioral theories to intervene to improve care for Veterans at risk for amputation. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed, it will be an important scientific contribution that could lower the risk of amputation in Veterans with diabetes.
This study will evaluate a comprehensive personalized behavioral intervention aimed to improve foot self-care, self- monitoring (which includes dermal thermometry), and modifiable risks for amputation such as peripheral vascular disease (PVD), A1c, BP and LDL to prevent diabetic foot ulcers in Veterans at higher than normal risk of amputation. This intervention is a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost- effective approach to improving diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to ulceration.
