OBJECTIVES: The purpose of this analysis is to compare the costs of healing diabetic foot ulcers using two different human allograft treatments over a 16-week period in similar type patients.

METHODS: Matched diabetic patients from 2 published studies, based on comorbidities , age, sex, wound size, and wound location were evaluated over a 16-week period for complete diabetic foot ulcer (DFU) closure defined as (100%) re-epithelialization (healing) in using both cryopreserved umbilical cord (Neox) and human placental membrane (Grafix). The direct medical costs to achieve healing (100% re-epithelialization) including initial treatment and complications/sequelae (e.g. amputation) were evaluated in a decision tree model (TreeAge Pro 2017). Sensitivity analysis using a tornado diagram and one-way sensitivity evaluated those variables which had the greatest effect on the model.

RESULTS: The baseline characteristics of the patients were similar, though only the Neox group had been positively diagnosed with osteomyelitis. Compared to Grafix, Neox resulted in a lower overall cost ($13,751 less costly) to achieve healing over the 16-week period ($9,895 vs. $23,646). Healing rates at 16 weeks were higher in Neox vs. Grafix (56% vs. 52%; ITT analysis). Sensitivity analysis identified the following variables and threshold values affecting which therapy to use (value at which Grafix would be the less costly alternative): cost Grafix applications <$2,440 and cost of Neox applications >$19,516.

CONCLUSIONS: In complex DFUs with exposed tendon, muscle or bone, the use of Neox was the less costly option to attain higher wound closure rates over the same time period. This was due to the fact that fewer Neox product applications were required. Prospective randomized controlled trials or manufacturer sponsored registries might be considered in order to verify these early results for this serious condition and unmet medical need.