Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers

2019 ◽  
Vol 28 (12) ◽  
pp. 808-816 ◽  
Author(s):  
Ralf Lobmann ◽  
Matthias Augustin ◽  
Holger Lawall ◽  
Wolfgang Tigges ◽  
Christoph Potempa ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Markov Model ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Treatment Costs ◽  
Sensitivity Analyses ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Serious Adverse Events ◽  
Double Blind

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.

scholarly journals Pirfenidone Accelerates Wound Healing in Chronic Diabetic Foot Ulcers: A Randomized, Double-Blind Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
Luz E. Gasca-Lozano ◽  
Silvia Lucano-Landeros ◽  
Héctor Ruiz-Mercado ◽  
Adriana Salazar-Montes ◽  
Ana Sandoval-Rodríguez ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Collagen Fiber ◽  
Controlled Trial ◽  
Inflammatory Cells ◽  
Foot Ulcers ◽  
Diallyl Disulfide ◽  
Diabetic Foot Ulcers ◽  
Double Blind ◽  
Antiseptic Agent ◽  
Healing Score

Background. Diabetic foot ulcers are one disabling complication of diabetes mellitus. Pirfenidone (PFD) is a potent modulator of extracellular matrix. Modified diallyl disulfide oxide (M-DDO) is an antimicrobial and antiseptic agent. Aim. To evaluate efficacy of topical PFD + M-DDO in a randomized, double-blind trial versus ketanserin in the treatment of noninfected chronic DFU. Methods. Patients received PFD + M-DDO or ketanserin for 6 months. Relative ulcer volume (RUV) was measured every month; biopsies were taken at baseline and months 1 and 2 for histopathology and gene expression analysis for COL-1α, COL-4, KGF, VEGF, ACTA2 (α-SMA), elastin, fibronectin, TGF-β1, TGF-β3, HIF-1α, and HIF-1β. Results. Reduction of median RUV in the PFD + M-DDO group was 62%, 89.8%, and 99.7% at months 1–3 and 100% from months 4 to 6. Ketanserin reduced RUV in 38.4%, 56%, 60.8%, 94%, 94.8%, and 100% from the first to the sixth month, respectively. Healing score improved 4.5 points with PFD + M-DDO and 1.5 points with ketanserin compared to basal value. Histology analysis revealed few inflammatory cells and organized/ordered collagen fiber bundles in PFD + M-DDO. Expression of most genes was increased with PFD + M-DDO; 43.8% of ulcers were resolved using PFD + M-DDO and 23.5% with ketanserin. Conclusion. PFD + M-DDO was more effective than ketanserin in RUV reduction.

scholarly journals Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245652
Author(s):  
Franck Maunoury ◽  
Anaïs Oury ◽  
Sophie Fortin ◽  
Laetitia Thomassin ◽  
Serge Bohbot ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Diabetic Foot ◽  
Cost Savings ◽  
Wound Dressings ◽  
Sensitivity Analyses ◽  
Foot Ulcers ◽  
Base Case ◽  
Diabetic Foot Ulcers ◽  
Lifetime Horizon ◽  
Life Years

This study assesses the cost-effectiveness of Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) wound dressings versus neutral dressings in the management of diabetic foot ulcers (DFUs) from a French collective perspective. We used a Markov microsimulation cohort model to simulate the DFU monthly progression over the lifetime horizon. Our study employed a mixed method design with model inputs including data from interventional and observational studies, French databases and expert opinion. The demographic characteristics of the simulated population and clinical efficacy were based on the EXPLORER double-blind randomized controlled trial. Health-related quality of life, costs, and resource use inputs were taken from the literature relevant to the French context. The main outcomes included life-years without DFU (LYsw/DFU), quality-adjusted life-years (QALYs), amputations, and lifetime costs. To assess the robustness of the results, sensitivity and subgroup analyses based on the wound duration at treatment initiation were performed. Treatment with the TLC-NOSF dressing led to total cost savings per patient of EUR 35,489, associated with gains of 0.50 LYw/DFU and 0.16 QALY. TLC-NOSF dressings were established as the dominant strategy in the base case and all sensitivity analyses. Furthermore, the model revealed that, for every 100 patients treated with TLC-NOSF dressings, two amputations could be avoided. According to the subgroup analysis results, the sooner the TLC-NOSF treatment was initiated, the better were the outcomes, with the highest benefits for ulcers with a duration of two months or less (+0.65 LYw/DFU, +0.23 QALY, and cost savings of EUR 55,710). The results from the French perspective are consistent with the ones from the German and British perspectives. TLC-NOSF dressings are cost-saving compared to neutral dressings, leading to an increase in patients’ health benefits and a decrease in the associated treatment costs. These results can thus be used to guide healthcare decisionmakers. The potential savings could represent EUR 3,345 per treated patient per year and even reach EUR 4,771 when TLC-NOSF dressings are used as first line treatment. The EXPLORER trial is registered with ClinicalTrials.gov, number NCT01717183.

Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing

2020 ◽  
Vol 29 (10) ◽  
pp. 543-551
Author(s):  
Ralf Lobmann ◽  
Arthur Grünerbel ◽  
Holger Lawall ◽  
Claas Lüdemann ◽  
Stephan Morbach ◽  
...  
Keyword(s):  
Wound Healing ◽  
Cost Effectiveness ◽  
Markov Model ◽  
Diabetic Foot ◽  
Treatment Costs ◽  
Wound Dressings ◽  
Double Blind ◽  
Direct Treatment ◽  
Sucrose Octasulfate ◽  
The Impact

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.

The Cost Effectiveness of Apligraf?? Treatment of Diabetic Foot Ulcers

2003 ◽  
Vol 21 (16) ◽  
pp. 1171-1183 ◽  
Author(s):  
W Ken Redekop ◽  
Joseph McDonnell ◽  
Paul Verboom ◽  
Kornelia Lovas ◽  
Zoltan Kalo
Keyword(s):  
Cost Effectiveness ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
The Cost

scholarly journals Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound-Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): An Open-Label Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4032
Author(s):  
José Luis Lázaro-Martínez ◽  
Francisco Javier Álvaro-Afonso ◽  
David Sevillano-Fernández ◽  
Yolanda García-Álvarez ◽  
Irene Sanz-Corbalan ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Cellular Proliferation ◽  
Controlled Trial ◽  
Surgical Debridement ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Debridement ◽  
Randomized Controlled ◽  
Ultrasound Assisted ◽  
Surgical Group

We aimed to evaluate the effects of ultrasound-assisted wound (UAW) debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving 51 outpatients with complicated diabetic foot ulcers that either received surgical debridement (n = 24) or UAW debridement (n = 27) every week during a six-week treatment period. Compared to patients receiving surgical debridement, patients treated with UAW debridement exhibited significantly improved cellular proliferation, as determined by CD31 staining, Masson’s trichrome staining, and actin staining. Bacterial loads were significantly reduced in the UAW debridement group compared to the surgical group (UAW group 4.27 ± 0.37 day 0 to 2.11 ± 0.8 versus surgical group 4.66 ± 1.21 day 0 to 4.39 ± 1.24 day 42; p = 0.01). Time to healing was also significantly lower (p = 0.04) in the UAW group (9.7 ± 3.8 weeks) compared to the surgical group (14.8 ± 12.3 weeks), but both groups had similar rates of patients that were healed after six months of follow-up (23 patients (85.1%) in the UAW group vs. 20 patients (83.3%) in the surgical group; p = 0.856). We propose that UAW debridement could be an effective alternative when surgical debridement is not available or is contraindicated for use on patients with complicated diabetic foot ulcers.

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