STEP UP to Avert Amputation in Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- VA Office of Research and Development
- Enrollment
- 241
- Locations
- 1
- Primary Endpoint
- Ulceration
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Ulceration
Time Frame: 18 months
High-resolution standard view digital photographs of the feet and footwear will be obtained and reviewed by the investigators blinded to group assignment, and a suspected ulcer or nonulcerative plantar lesion below the malleoli will be referred to a panel of three blinded (as to group assignment) adjudicators, all clinical experts. Lesions will be judged as absent/nonulcerative lesion/ulcer; involving/not involving the plantar surface (defined as involving the weight-bearing surface of the foot); and related to metatarsal head (MTH)/not related to MTH. Adjudicators will not confer with each other or with the study staff, and the majority opinion will be taken as the final judgment. Ulcers will be judged to be present if the integrity of both the epidermis and dermis is broken. When ulcers occur in between study visits, the adjudication committee will review the medical records and make the determination.
Secondary Outcomes
- Foot health-specific quality of life(18 months)
- Foot care skills(18 months)
- General Quality of Life(18 months)
- plantar pressure(18 months)
- step count(18 months)