036 MIST Ultrasound: The results of a multicenter, randomized, double-blind, sham-controlled trial of the healing of diabetic foot ulcers

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.

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

Journal of Diabetes Research ◽

10.1155/2017/3159798 ◽

2017 ◽

Vol 2017 ◽

pp. 1-12 ◽

Cited By ~ 6

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.

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Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial

The Lancet Diabetes & Endocrinology ◽

10.1016/s2213-8587(17)30438-2 ◽

2018 ◽

Vol 6 (3) ◽

pp. 186-196 ◽

Cited By ~ 71

Author(s):

Michael Edmonds ◽

José Luis Lázaro-Martínez ◽

Jesus Manuel Alfayate-García ◽

Jacques Martini ◽

Jean-Michel Petit ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Diabetic Foot ◽

Controlled Trial ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Double Blind ◽

Sucrose Octasulfate ◽

Randomised Controlled

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Is there randomized controlled trial evidence to support the use of growth factors for diabetic foot ulcers?

Cochrane Clinical Answers ◽

10.1002/cca.1093 ◽

2016 ◽

Author(s):

Carlos Fernando Grillo-Ardila

Keyword(s):

Randomized Controlled Trial ◽

Growth Factors ◽

Diabetic Foot ◽

Controlled Trial ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Randomized Controlled ◽

Trial Evidence

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Autologous platelet rich plasma promotes the healing of non-ischemic diabetic foot ulcers. A randomized controlled trial

Annals of Vascular Surgery ◽

10.1016/j.avsg.2021.10.061 ◽

2021 ◽

Author(s):

El Mahdy Hossam ◽

Ayman H.K. Alserr ◽

Constantine N. Antonopoulos ◽

Ahmed Zaki ◽

Waleed Eldaly

Keyword(s):

Randomized Controlled Trial ◽

Diabetic Foot ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Randomized Controlled ◽

Autologous Platelet Rich Plasma ◽

Autologous Platelet

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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

Journal of Clinical Medicine ◽

10.3390/jcm9124032 ◽

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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