Clinical trial NCT02356848: STEP UP to Avert Amputation in Diabetes
Official title: STEP UP to Avert Amputation in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Foot Ulcer
Keywords: self-care
self-monitoring
secondary prevention
foot ulcer
Diabetic Foot Ulcer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-02-05
Enrollment: 241
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 amputation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults (21 years) with Type 2 diabetes
* History of healed diabetic foot ulcer (\>3 months)
* Diabetes 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ulceration
timeFrame: 18 months
Secondary outcomes:
measure: Foot care skills
timeFrame: 18 months
measure: General Quality of Life
timeFrame: 18 months
measure: Foot health-specific quality of life
timeFrame: 18 months
measure: plantar pressure
timeFrame: 18 months
measure: step count
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Sundar Natarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: