STEP UP to Avert Amputation in Diabetes

NIH RePORTER · VA · I01 · · view on reporter.nih.gov ↗

Abstract

 DESCRIPTION (provided by applicant): Anticipated Impacts on Veterans' Healthcare: While amputation rates for veterans with diabetes have been reduced with system and provider intervention, they continue to be high. Amputation is a devastating complication that is preceded in > 80% of cases by a diabetic foot ulcer. This study applies advanced behavioral theories to intervene to improve care for Veterans at risk for amputation combined with dermal thermometry. If this promising theory-driven approach can work in a clinical setting where improvements in foot care are urgently needed for these vulnerable Veterans with a previous ulcer, it will be an important scientific contribution that coud lower the risk of recurrent ulcers and amputation in Veterans with diabetes. Project Background: Veterans with diabetes who have had a previous ulcer are at highest risk for new ulcers and amputation, particularly if they have neuropathy or vascular disease and have poor foot self-care or non- adherence to diet, medication, and exercise recommendations. It is difficult to activate at-risk patients to improve self-care and detect foot abnormalities or inflammation at an early stage, particularly when they have other risks to manage. Interventions targeting mediators of amputation risk (ulcer recurrence) promise to lower risk and improve outcomes in these high-risk Veterans. Dermal thermometry effectively allows for early identification of inflammation and is a warning sign to contact a healthcare professional. Interventions are more effective when they are behaviorally tailored and combine multiple behavioral theories. This study will evaluate a comprehensive risk-stratified personalized tailored intervention aimed to improve self-care and reduce ulcer recurrence in Veterans with diabetes and prior diabetic foot ulcer. Project Objectives: Proposed is a randomized controlled trial (RCT) testing the effectiveness of a comprehensive tailored intervention (TI) aimed to improve self-care and self-monitoring (including dermal thermometry) through behavioral counseling. The primary specific aim is to evaluate if TI reduces the proportion of recurrent ulcers at 18 months compared to the current practice (CP) group. The secondary specific aims are to evaluate the impact of TI on foot care skills, quality of life (QOL), peak plantar pressure, and step count compared to CP at 18 months. Exploratory aims will be to examine the impact of TI on amputation, gait temporal-spatial parameters, C-reactive protein, glycosylated hemoglobin (A1c) and depression at 18 months compared to CP. Project Methods: We will recruit adults with diabetes who have had a previously healed foot ulcer. Using a blinded RCT, we will test the effect of TI in relation to CP. Participants in TI will receive a comprehensive intervention including telephone counseling and tailored mailings from health counselors. The TI is an integrated, personalized intervention targeting foot self-care and se...

Key facts

NIH application ID
9905319
Project number
5I01RX001858-06
Recipient
VA MEDICAL CENTER
Principal Investigator
SUNDAR NATARAJAN
Activity code
I01
Funding institute
VA
Fiscal year
2020
Award amount
Award type
5
Project period
2015-03-01 → 2020-11-30