The CareFUL Prevention Trial

Exclusion Criteria

• •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.