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Objective: To develop a venous leg ulcer (VLU) risk stratification system for use in research and clinical practice. Approach: U.S. Wound Registry data were examined retrospectively and assigned an outcome. Bivariate analysis identified significant variables ( p < 0.05) that were used to create a multivariable logistic regression model. Ulcers with data for wound area at the first visit before debridement were included in regression analysis, which was based on a 90% development sample. The model was validated on a hold-out 10% data sample. Results: The original dataset included 26,713 VLUs, of which 11,773 ulcers were eligible for preliminary analysis and 10,942 ulcers were eligible for regression analysis. The 90% development model included 9,898 ulcers, of which 7,498 healed (75.8%). The 10% validation sample included 1,044 ulcers, of which 809 healed (77.5%). The following variables significantly predicted healing: number of concurrent wounds of any etiology, wound size, wound age (in days), evidence of bioburden/infection, being nonambulatory, and hospitalization for any reason. Innovation: The VLU Wound Healing Index (WHI) is a comprehensive, validated risk stratification model for predicting VLU healing that incorporates patient- and wound-specific variables. Conclusions: The WHI can identify which VLUs most likely require adjunctive therapies to heal, prioritize referral to venous experts, risk-stratify ulcers to create more generalizable clinical trials and understand the impact of clinical interventions. The Centers for Medicare and Medicaid Services accepts this method for reporting VLU outcome under the Quality Payment Program.
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Fife et al. (2019) studied this question.
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