Quality of life in healing diabetic wounds: does the end justify the means?

The objective of this investigation was to compare the health-related quality of life (QoL) among persons participating in a randomized clinical trial of pressure-offloading modalities to heal diabetic foot wounds and diabetic neuropathic foot ulcers. In this prospective clinical trial, 63 patients with superficial noninfected, non-ischemic plantar neuropathic diabetic foot ulcers were randomized to 1 of 3 offloading modalities: total contact cast (TCC), a half-shoe, or a removable cast walker (RCW). A Short-Form 36 questionnaire (SF-36) was used to measure health-related QoL of patients before and after the 12-week study period. The overall mean baseline physical and mental summary scores for the entire population studied were 65.2 +/- 6.5 and 60.7 +/- 5.3, respectively. There were statistically significant differences between the pre- and posttreatment responses in 7 of the 8 SF-36 scales, with the nonsignificant trend in all cases signifying improvement in overall QoL. Patients' overall QoL improved regardless of the pressure-offloading device employed, although this trend was erased when the groups were dichotomized based on whether or not they healed during the study period. In conclusion, the results of this study suggest the potential moderating role of closure of a foot ulcer on the effects of the offloading modality on a patient's QoL. Specifically, the results suggest that in diabetic patients with neuropathic foot ulcers, QoL may have less to do with how an index wound is treated than it does with whether or not the wound heals.

RCT Entities:   Population Interventions Outcomes