This study will evaluate a comprehensive tailored behavioral intervention aimed to improve
foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent
ulcers in Veterans at highest risk of amputation. This intervention may be 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 improve diabetes-related foot health behavior,
and other risk factors in patients who are vulnerable to devastating consequences related to
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 nonadherence 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.
Proposed is a randomized controlled trial 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 time to ulceration,
quality of life (QOL), plantar pressure, physical activity and foot care skills compared to
the CP group.
The investigators will recruit adults with diabetes who have had a previously healed ulcer.
The intervention will be standardized and fidelity of the intervention will be maintained.
Using a blinded randomized controlled trial (RCT), the investigators will test the effect of
TI in relation to CP. Key outcomes are ulceration, quality of life (QOL), plantar pressure,
physical activity and foot care skills. Outcomes will be measured at baseline, 6, 12 and 18
months. All analyses will be intent-to-treat.
This study will evaluate a comprehensive tailored intervention targeting multiple behaviors
related to self-care and amputation risk. 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 could lower the risk of recurrent
ulcers and amputation in Veterans with diabetes.
- Adults (21 years) with Type 2 diabetes
- History of healed diabetic foot ulcer (>3 months)
- Diabetes drug therapy for > 6 months
- An available phone and receiving continuity of care at the VA (at least 2 primary care
visits in the previous 1.5 years at the recruitment site)
- Patients with an active foot ulcer
- Acute cardiovascular disease (CVD) events < 3 months ago
- Poor estimated short-term survival (< 1 year)
- Recent major surgery (< 3 months)
- Prior foot amputation
- Inability to exercise
- Temporary residence in the area
- Inability to provide consent will be excluded
Sundar Natarajan, MD MSc
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Sundar Natarajan, MD MSc
Phone: (212) 686-5000