Filgrastim in the Treatment of Infected Diabetic Foot Ulcers: Retrospective Cost Analysis of a Phase II Randomised Clinical Trial.

Objective: A retrospective cost-minimisation study of a randomised clinical trial comparing the resource use and treatment cost of hospitalised diabetic patients with infected foot ulcers with and without filgrastim (5 µg/kg/day) support for 7 days consecutively. Design: Costs were estimated from the hospital perspective. Resource use data were collected from patient record files. Unit cost data were gathered from the hospital administration records. A decision tree model was built to estimate the mean cost for each treatment arm. Patients: Forty patients were randomised. At study entry, all had infected ulcers and were clinically investigated regarding their vascular condition. At inclusion no significant difference was observed between cases and controls. Results: Clinical results showed that the recovery of the filgrastim-treated patient was quicker, resulting in an earlier hospital discharge. The intent-to-treat cost analysis demonstrated that the mean cost savings were £2666 (36%) in favour of the filgrastim treatment arm. Sensitivity analysis was performed on patient type, probability distribution, unit cost and hospital duration. Subgroup analysis identified that the cost savings ranged from £3129 (39%) to £155 (4%) when patients with vascular problems and/or tissue necrosis were excluded from the analysis. Conclusion: The overall clinical benefit observed with the use of filgrastim could be translated into cost savings. These measured cost savings should, however, be interpreted cautiously as patient selection may have occurred that appeared during the in-hospital stay. More patients in the control group experienced a bad vascular condition inducing more costly interventions. The results need therefore to be confirmed in a large phase III randomised clinical trial. [ABSTRACT FROM AUTHOR]