4.5.0.0 Treat­ment

Peo­ple with neu­ropa­thy or ev­i­dence of in­creased plan­tar pres­sures (e.g., ery­the­ma, warmth, or cal­luses) may be ad­e­quately man­aged with well-fitted walk­ing shoes or ath­let­ic shoes that cush­ion the feet and re­dis­tribute pres­sure. Peo­ple with bony de­for­mi­ties (e.g., ham­mer­toes, promi­nent metatarsal heads, bunions) may need extra wide or deep shoes. Peo­ple with bony de­for­mi­ties, in­clud­ing Char­cot foot, who can­not be ac­com­mo­dat­ed with com­mer­cial ther­apeutic footwear, will re­quire cus­tom-‍mold­ed shoes. Spe­cial con­sid­eration and a thor­ough workup should be per­formed when pa­tients with neu­ropa­thy pre­sent with the acute onset of a red, hot, swollen foot or ankle, and Char­cot neu­roarthropa­thy should be ex­clud­ed. Early di­ag­no­sis and treat­ment of Char­cot neu­roarthropa­thy is the best way to pre­vent de­for­mi­ties that in­crease the risk of ul­cer­a­tion and am­pu­ta­tion. The rou­tine pre­scrip­tion of ther­apeutic footwear is not gen­er­ally rec­om­mend­ed. How­ev­er, pa­tients should be pro­vided ad­e­quate in­for­ma­tion to aid in se­lec­tion of ap­pro­pri­ate footwear. Gen­er­al foot-‍wear rec­om­men­da­tions in­clude a broad and square toe box, laces with three or four eyes per side, padded tongue, qual­i­ty lightweight ma­te­ri­als, and sufficient size to ac­com­mo­date a cush­ioned in­sole. Use of cus­tom ther­apeutic footwear can help re­duce the risk of fu­ture foot ul­cers in high-‍risk pa­tients (145,147).

Most di­a­bet­ic foot in­fec­tions are polymi­cro­bial, with aer­o­bic gram-‍pos­i­tive cocci. Staphy­lo­coc­ci and strep­to­coc­ci are the most com­mon causative or­gan­isms. Wounds with­out ev­i­dence of soft tis­sue or bone in­fec­tion do not re­quire an­tibi­ot­ic ther­a­py. Em­pir­ic an­tibi­ot­ic ther­a­py can be nar­row­ly tar­geted at gram-‍pos­i­tive cocci in many pa­tients with acute in­fec­tions, but those at risk for in­fec­tion with an­tibi­ot­ic-‍re­sis­tant or­gan­isms or with chron­ic, pre­vi­ous­ly treat­ed, or se­vere in­fec­tions re­quire broad­er-‍spec­trum reg­i­mens and should be re­ferred to spe­cialized care cen­ters (148). Foot ul­cers and wound care may re­quire care by a po­di­a­trist, or­tho­pe­dic or vas­cu­lar sur­geon, or re­ha­bil­i­ta­tion spe­cialist ex­pe­ri­enced in the man­age­ment of in­di­vid­u­als with di­a­betes (148).

Hy­per­bar­ic oxy­gen ther­a­py (HBOT) in pa­tients with di­a­bet­ic foot ul­cers has mixed ev­i­dence sup­port­ing its use as an ad­junc­tive treat­ment to en­hance wound heal­ing and pre­vent am­pu­ta­tion (149-151). In a rel­a­tive­ly high-‍qual­i­ty dou­ble-‍blind study of pa­tients with chron­ic di­a­bet­ic foot ul­cers, hy­per­bar­ic oxy­gen as an ad­junc­tive ther­a­py re­sulted in significant­ly more com­plete heal­ing of the index ulcer in pa­tients treat­ed with HBOT com­pared with place­bo at 1 year of fol­low-‍up (152). How­ev­er, mul­ti­ple sub­se­quently pub­lished stud­ies have ei­ther failed to demon­strate a benefit of HBOT or have been rel­a­tive­ly small with po­ten­tial flaws in study de­sign (150). A well-con­ducted ran­domized con­trolled study per­formed in 103 pa­tients found that HBOT did not re­duce the in­di­ca­tion for am­pu­ta­tion or fa­cil­i­tate wound heal­ing com­pared with com­pre­hen­sive wound care in pa­tients with chron­ic di­a­bet­ic foot ul­cers (153). A sys­tematic re­view by the In­ter­na­tion­al Work­ing Group on the Di­a­bet­ic Foot of in­ter­ven­tions to im­prove the heal­ing of chron­ic di­a­bet­ic foot ul­cers con­clud­ed that anal­y­sis of the ev­i­dence con­tin­ues to pre­sent method­olog­i­cal chal­lenges as ran­domized con­trolled stud­ies re­main few, with a ma­jor­i­ty being of poor qual­i­ty (150). HBOT also does not seem to have a significant ef­fect on health-‍re­lat­ed qual­i­ty of life in pa­tients with di­a­bet­ic foot ul­cers (154,155). A re­cent re­view con­clud­ed that the ev­i­dence to date re­mains in­con­clu­sive re­gard­ing the clin­i­cal and cost-ef­fectiveness of HBOT as an ad­junc­tive treat­ment to stan­dard wound care for di­a­bet­ic foot ul­cers (156). Re­sults from the re­cently pub­lished Dutch DAMO­CLES (Does Ap­ply­ing More Oxy­gen Cure Lower Ex­trem­i­ty Sores?) trial demon­strated that HBOT in pa­tients with di­a­betes and is­chemic wounds did not significant­ly im­prove com­plete wound heal­ing and limb sal­vage (157). The Cen­ters for Medi­care & Med­i­caid Ser­vices cur­rently cov­ers HBOT for di­a­bet­ic foot ul­cers that have failed a stan­dard course of wound ther­a­py when there are no mea­sur­able signs of heal­ing for at least 30 con­sec­u­tive days (158). HBOT should be a topic of shared de­ci­sion mak­ing be­fore treat­ment is con­sid­ered for se­lect­ed pa­tients with di­a­bet­ic foot ul­cers (158).