Does a Therapeutic Stocking Prevent Diabetic Foot Ulcer Recurrence in a Randomized Controlled Trial?

Objective To evaluate the effectiveness of a protective foot care (PFC) stocking on the recurrence of diabetic foot ulcers. Methods Three hundred eighty-one subjects with previously healed diabetic foot ulcers were prospectively enrolled and randomized to either patient-selected socks or PFC stockings, made of a two-layer padded, friction-reducing fiber. All patients received therapeutic shoes and insoles, diabetic foot education, and were followed every 12 weeks for a total of 30 months. Patients in the PFC group were given seven new pairs of stockings at each visit. This study was performed at sites in Texas and the UK and investigators were blinded to the treatment. We compared intervention groups with t test and chi square. Results At baseline, there were no differences between groups for sex, age, history of amputation, or retinopathy. There was no difference in the incidence of ulcer development (stocking 39% vs control 44%, p=0.31). width="0"> > > colspan="2" width="222"> > width="138"> Stocking N=195 > width="132"> Control N=186 > width="78"> p-value__  > > > colspan="2" width="222"> Male__  > width="138"> 144 > width="132"> 143 > width="78"> 0.49 > > > colspan="2" width="222"> Age__  > width="138"> 52.1±11.1 > width="132"> 56.1±6.8 > width="78"> 0.28 > > > colspan="2" width="222"> Race/Ethnicity > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Caucasian > width="138"> 166 > width="132"> 144 > width="78"> 0.053 > > > width="24"> > width="198"> African > width="138"> 17 > width="132"> 23 > width="78"> 0.25 > > > width="24"> > width="198"> Asian > width="138"> 6 > width="132"> 13 > width="78"> 0.08 > > > width="24"> > width="198"> Other > width="138"> 2 > width="132"> 3 > width="78"> 0.61 > > > width="24"> > width="198"> Hispanic > width="138"> 56 > width="132"> 42 > width="78"> 0.17 > > > colspan="2" width="222"> Region of enrollment > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> United States > width="138"> 125 > width="132"> 109 > width="78"> 0.27 > > > width="24"> > width="198"> United Kingdom > width="138"> 70 > width="132"> 77 > width="78"> > > > colspan="2" width="222"> Diabetes > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Type 2 > width="138"> 173 > width="132"> 161 > width="78"> 0.52 > > > colspan="2" width="222"> Ankle brachial index_  > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Right PT > width="138"> 1.1±0.24 > width="132"> 1.1±0.29 > width="78"> 0.43 > > > width="24"> > width="198"> Right DP > width="138"> 1.1±0.28 > width="132"> 1.1±0.29 > width="78"> 0.79 > > > width="24"> > width="198"> Left PT > width="138"> 1.1±0.29 > width="132"> 1.2±0.29 > width="78"> 0.23 > > > width="24"> > width="198"> Left DP > width="138"> 1.1±0.23 > width="132"> 1.1±0.25 > width="78"> 0.33 > > > colspan="2" width="222"> Neuropathy > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Right VPT >25Hz > width="138"> 132 > width="132"> 139 > width="78"> 0.13 > > > width="24"> > width="198"> Right missed spots on SWMF > width="138"> 176 > width="132"> 156 > width="78"> 0.06 > > > width="24"> > width="198"> Left VPT >25Hz > width="138"> 129 > width="132"> 143 > width="78"> 0.02 > > > width="24"> > width="198"> Left missed spots on SMWF > width="138"> 168 > width="132"> 176 > width="78"> 0.02 > > > colspan="2" width="222"> Previous foot amputation > width="138"> 55 > width="132"> 64 > width="78"> 0.19 > > > colspan="2" width="222"> Smoking history > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Current smoker > width="138"> 25 > width="132"> 23 > width="78"> 0.89 > > > width="24"> > width="198"> Former smoker > width="138"> 62 > width="132"> 51 > width="78"> 0.35 > > > colspan="2" width="222"> Alcohol consumption > width="138"> > width="132"> > width="78"> > > > width="24"> > width="198"> Current drinker > width="138"> 57 > width="132"> 54 > width="78"> 0.97 > > > width="24"> > width="198"> Former drinker > width="138"> 42 > width="132"> 27 > width="78"> 0.08 > > > colspan="2" width="222"> Retinopathy > width="138"> 66 > width="132"> 60 > width="78"> 0.74 > > > colspan="2" width="222"> Outcome > width="138"> > width="132"> > width="78"> > > > colspan="2" width="222"> Developed ulcer > width="138"> 76 > width="132"> 82 > width="78"> 0.31 > > > > Conclusion Preliminary studies showed significant reduction in plantar pressures with use of padded socks, but this trial showed no difference in the incidence of ulcer development. DFU healing is multifactorial. Padding the foot alone does not counteract the effect of pathomechanics, foot deformity, or vascular compromise.