The CareFUL Prevention Trial

Inclusion Criteria:

1. Men and women, 18 years of age or older at the time of consent;

2. Clinical diagnosis of Diabetes Mellitus ;

3. At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months
since heeling), based on medical records or if these cannot be obtained to the
subject's best recollection OR current or recurring hemorrhage into callus under at
least one MTH in a patient with a prior MTH related plantar ulcer that has been
documented in the medical record;

4. Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the
area of current hemorrhagic callus >450 kPa;

5. Loss of Protective Sensation (refer to Section 7.2.6);

6. Community ambulator defined as having the ability or potential for ambulation outside
in the community including the ability to traverse low-level environmental barriers
such as curbs, stairs, or uneven surfaces, or better by subject report;

7. Ability to give consent;

8. In the opinion of the site PI the subject is willing and able to comply with the
scheduled visits, treatment plan, and other trial procedures for the duration of the
study.

Exclusion Criteria:

1. 1. Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion
of the site PI;

2. Partial foot amputation greater than of two metatarsal heads or rays per foot; toe
amputations with the metatarsal heads left in place are permissible; complete foot
amputation on one side (i.e. ambulation with a prosthesis) is permissible;

3. Charcot process that is active in the opinion of the site PI (requires immobilization
beyond use of footwear that would be available through the study);

4. A prior ulcer on the plantar aspect of the heel within the last year, to the
subject's best recollection that in the opinion of the site PI has high probability
of recurring in the study footwear;

5. A prior ulcer on the weightbearing aspect of any toe within the last year, to the
subject's best recollection that in the opinion of the site PI has high probability
of recurring in the study footwear;

6. A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence
at any time in the past, to the subject's best recollection that in the opinion of
the site PI has high probability of recurring in the study footwear;

7. A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence
at any time in the past, if the associated plantar pressure is >450kPa

8. Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar
pressure;

9. Need for an ankle-foot orthoses in the opinion of the site PI or another provider;

10. Need for more complex intervention, i.e. the site PI's decision is that the study
footwear would not be adequate for the subject's needs, e.g. a rigid outsole or
custom molded shoes are deemed necessary.