Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
Brief Summary: The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further.

The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy.

The specific aims of the study are:

* To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
* To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.


Options:
A: Inclusion Criteria:

* Diagnosed type 1 or 2 diabetes mellitus
* Age 50 years or older
* Absent 5.07 Semmes Weinstein monofilament sensation to \> 1 point on both feet
* Residence within 50 miles of Columbia, MO
* Functioning telephone service
* Not currently participating in 20 or more minutes of moderately intense activity more than twice a week

Exclusion Criteria:

* Hospitalization in the last year for any of the following reasons:
* Proliferative diabetic retinopathy
* Accelerated hypertension (systolic BP \>200 or diastolic BP \> 120)
* Myocardial infarction or unstable angina
* New hemodynamically significant arrhythmia
* Acute congestive heart failure
* Failure to attend 3 of the last 5 scheduled clinic visits
* Foot deformities requiring a custom shoe
* "Timed Up and Go" test 3 \> 15 seconds Subjects unable to ambulate without assistance
* Severe cardiac autonomic neuropathy
* Lower extremity amputation \> one digit
* Heart, kidney or other transplant
* Currently unhealed foot ulcer (or healed for less than 1 month
B: Inclusion Criteria:

1. T2D defined by ADA criteria.
2. Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".
3. Moderate DPN severity with a UENS of 2-18.
4. Age between 30 and 75.
5. Under the care of an identified Primary Care Physician (PCP).

Exclusion Criteria:

1. Any alternative cause for peripheral neuropathy. The following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin B12, serum protein electrophoresis and immunofixation. ANA and TSH may be obtained if clinically indicated and not available from clinical records.
2. Family history of a non-diabetic neuropathy in a first-degree relative.
3. Severe or longstanding neuropathy: UENS \> 18 or history of foot ulceration or amputation.
4. Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator.
5. Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
6. A serious medical condition that might shorten life span or prevent exercise.
7. Subjects with obesity or hypertension considered in a dangerous range (BMI\> 45, systolic BP \>170, or diastolic BP \>110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons.
8. An inability to understand or cooperate with the procedures of the study
9. Females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy.
10. If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
C: Inclusion Criteria:

* Age \>18 years AND admitted to critical care unit
* Ventilated \>48-hours (via endotracheal tube) OR received continuous non- invasive ventilation (NIV)/non-invasive continuous positive airways pressure (CPAP)
* Admitted to ICU \> 48-hours and evidence of SIRS
* Glasgow Coma Score (GCS) 15 (of 15) AND Abbreviated Mini-Mental Test Score (AMMTS) \>/= 8 (of 10) on enrolment into rehabilitation programme
* Mobilising on ward to a degree sufficient as to begin a majority of proposed exercises. Clinical stability for observed exercise as judged by trial team is a prerequisite.
* Participant willingness to complete a programme of exercise based therapy aimed at reducing weakness and shortness of breath: subjective weakness or dyspnoea relative to their pre-admission state is implicit

Exclusion Criteria:

* Patients referred for terminal care or prognosis likely to be less than 12-months
* Unstable coronary artery syndrome
* Limb amputation (given special requirement for orthotics/rehabilitation)
* Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance \<100 metres)
* Stroke with hemiparesis (likely need for specialised rehabilitation/stay on stroke unit)
* Severe, disabling locomotor problem or severe burns, which prevent effective participation in the exercises contained in the rehabilitation programme.
* Psychiatric disease necessitating anti-psychotic medication, deliberate drug overdose as the admitting ICU indication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
* Patients undergoing renal haemodialysis (given the associated commitment to outpatient attendance)
* Extra contractual ICU referral (only if distance greater than suitable for twice weekly travel)

Additional exclusion criteria for muscle biopsy samples:

* Coagulopathy e.g. warfarin use
D: Inclusion Criteria:

* All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.

Exclusion Criteria:

* Patients with any evidence of use of diabetic peripheral neuropathy study medications.
* Patients with evidence of gestational diabetes (ICD-9: 648.8) due to variation in treatment and monitoring for women who are pregnant.
* Patients who simultaneously received a new diagnosis for depression or seizure conditions

Answer: A