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IIR 14-009 – HSR Study

IIR 14-009
Preventing Amputations by Tailored Risk-based Intervention to Optimize Therapy
Sundar Natarajan, MD MSc
VA NY Harbor Healthcare System, New York, NY
New York, NY
Funding Period: April 2015 - September 2020
Veterans with diabetes are at high 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 glycosylated hemoglobin A1c and other risk factors.

We are conducting 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), glycosylated hemoglobin (A1c), blood pressure (BP) and low-density lipoprotein (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, compared to CBP, 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 the aforementioned outcomes; and cost-effectiveness.

We will randomize 404 Veterans with diabetes who are at higher than normal risk of foot ulcers [Preventing Amputations in Veterans Everywhere (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 randomized controlled trial (RCT) design, 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.

Data collection is ongoing. We have enrolled 393 participants and randomized 327 participants by 3/27/18.

This study evaluates 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 and 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 contribution that could lower the risk of amputation in Veterans with diabetes.

External Links for this Project

NIH Reporter

Grant Number: I01HX001580-01A1

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Journal Articles

  1. Salovaara PK, Li C, Nicholson A, Lipsitz SR, Natarajan S. Navigating COVID-19 and related challenges to completing clinical trials: Lessons from the PATRIOT and STEP-UP randomized prevention trials. Clinical trials (London, England). 2023 Apr 1; 20(2):153-165. [view]

DRA: Aging, Older Veterans' Health and Care, Diabetes and Other Endocrine Conditions
DRE: Prevention
Keywords: Adherence, Cost-Effectiveness, Diabetes, Outcomes - Patient, Self-Care
MeSH Terms: none

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