Does Edetate Disodium Reduce Cost of Care of Patients with Diabetes and Critical Limb Ischemia?

Purpose: Edetate disodium-based therapy reduces cardiovascular events in post–myocardial infarction patients with diabetes and peripheral artery disease. We previously reported healing of open wounds, no amputations, and improved disease specific quality of life in seven patients completing at least 40 edetate disodium–based infusions. We calculated health care expenditures in the year preceding compared with the year following initiation of open-label edetate disodium–based infusions.

Materials and Methods: A retrospective chart review of seven patients who completed at least 40 infusions of edetate disodium–based therapy was performed, and information regarding procedures, imaging, and medical visits was recorded for 1 year before and 1 year after the start of this therapy, spanning years from 2014 to 2018. The cost of treatments was estimated using published national Medicare reimbursements. We do not present formal statistical testing because of the small sample size and exploratory nature of the analyses.

Results: The mean age of the seven patients was 76 years ± 8.3, and 57% were male, baseline urine creatinine was 0.92 ± 0.24 mg/dL (mean ± standard deviation). Coronary artery disease was found in 86% (n = 6), smoking history in 29% (n = 2), and nonhealing ulcer or dry gangrene in 57% (n = 4). The SVS WIFI risk staging score was high risk in 43% (n = 3) and moderate in 57% (n = 4). The median and interquartile ranges cost of treatment in the year before the first chelation infusion were $9560 ($4072–$37,212) and for the year after the first infusion $1295 ($758–$10,566), an 86% reduction.

Conclusions: Edetate disodium–based therapy may be an effective adjunct pharmacotherapy in the treatment of patients with critical limb ischemia. The present cost survey provides a signal that this therapy may be beneficial at a favorable cost. Larger studies will be necessary to further explore cost and benefit of this treatment. TACT3a, a double blind, placebo-controlled, randomized trial, is currently in progress.