ABSTRACT
OBJECTIVE: A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing. METHOD: Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model. RESULTS: The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of 2482-3278 (sucrose octasulfate dressing) and 2768-3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of 2482 and 2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of 3450 and 6054, respectively (CE=3520, 6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor. CONCLUSION: Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates.
Subject(s)
Anti-Ulcer Agents/administration & dosage , Bandages , Diabetic Foot/therapy , Sucrose/analogs & derivatives , Wound Healing , Adult , Aged , Aged, 80 and over , Diabetes Complications , Diabetes Mellitus , Diabetic Foot/drug therapy , Double-Blind Method , Female , Germany , Humans , Male , Middle Aged , Sucrose/therapeutic use , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Diabetes is one of the most widespread diseases in Germany. Common complications are diabetic foot ulcers (DFU), which are associated with a cost-intensive treatment and serious adverse events, such as infections, amputations. This cost-effectiveness analysis compares two treatment options for patients with DFU: a TLC-NOSF dressing versus a neutral dressing, assessed through a European double-blind randomised controlled trial (RCT), Explorer. METHODS: The evaluation of the clinical outcomes was associated to direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings, from the perspective of the statutory health insurance in Germany. Due to the long mean healing time of a DFU, the observation period was extended from 20 to 100 weeks in a Markov model. RESULTS: After 20 weeks, and with complete closure as a primary endpoint, the model revealed direct treatment costs for DFU of 2,864.21 when treated with a TLC-NOSF dressing compared with 2,958.69 with the neutral control dressing (cost-effectiveness: 6,017.25 versus 9,928.49). In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were 5,882.87 compared with 8,449.39 with the neutral dressing (cost-effectiveness: 6,277.58 versus 10,375.56). The robustness of results was underlined by several sensitivity analyses for varying assumptions. The frequency of weekly dressing changes had the most significant influence in terms of parameter uncertainty. CONCLUSION: Overall, the treatment of DFU with a TLC-NOSF dressing is supported from a health economic perspective, because both the treatment costs and the cost-effectiveness were superior compared with the neutral wound dressing.
