- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04039308
Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle
Přehled studie
Postavení
Podmínky
Detailní popis
Diabetes mellitus affected approximately 422 million people worldwide in 2016 . Diabetic complications including diabetic peripheral neuropathy and peripheral arterial disease remain prevalent in the USA and worldwide and challenging to treat. Due to loss of protective sensation and impaired vascular supply, these can lead to serious foot complications including deformity, diabetic foot ulceration, Charcot neuroarthropathy and infection .
Charcot neuroarthropathy is a devastating orthopedic condition that afflicts patients with diabetes. It is an inflammatory condition that affects the foot and ankle with varying degrees of bone destruction and deformity. The true incidence or prevalence of this condition is not known.
However, estimates demonstrate incidence to be between 0.1 and 0.9%
. Two principal pathways for the disease have been proposed. The neurotraumatic theory suggests that the loss of neuroprotection causes repetitive microtrauma. The opposing hypothesis, the neurovascular, is that sympathetic neuropathy results in hyperaemia. This leads to increased osteoclastic activity resulting in bone resorption and fragmentation.
The active form of charcot foot arthropahy is often misdiagnosed as tenosynovitis, cellulitis, or gout. The majority of these patients endure a short period of disability that is treated by some form of immobilization for a variable period of time with minimal resultant long-term disability. The diagnosis is not often clear until resolution of the swelling when a resultant residual deformity is appreciated.
Eichenholtz classification is used to define Charcot foot clinical stages. Brodsky the classification, in the other hand, allows us to locate the lesion anatomically.
The incidence of diabetic neuroarthropathy varies among the anatomical regions of the foot and ankle according to Brodsky classification. Approximately 70% of cases affect the tarsometatarsal joint (type 1). Type-1 disease is the least likely to require surgical stabilization, although the most common type to cause plantar ulceration. Type-2 disease involves the midtarsal and subtalar joints and accounts for approximately 20% of cases. Type-3 disease affects approximately 10% of patients, and occurs mainly in the ankle. Type 2 and type 3 are the most likely to progress to instability and often require long-term bracing or surgical reconstruction.
The surgical techniques described in the literature include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening and, eventually, amputation.The goal of Charcot neuroarthropathy treatment, both orthopedic and surgical is to obtain an ulcer free, stable plantigrade foot, without osteomyelitis and able to ambulate. Achieving these goals notably reduces the rate of amputations.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients with inactive form of Charcot arthropathy of the foot and ankle due to diabetes mellitus.
Patients received surgical management.
Exclusion Criteria:
- Active form of Charcot arthropathy of the foot and ankle. Non deforming Charcot arthropathy of the foot and ankle. Patients with heavy infection or vascular affection that necessitate amputation.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Pouze případ
- Časové perspektivy: Retrospektivní
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.
Časové okno: 3 years
|
Assessment of accuracy of correction in patients with Charcot neuroarthropathy of the foot and ankle using follow up x rays and measuring the foot and ankle angles.
The normal angles are documented, so we will compare these angles with the normal ones.
|
3 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 1-World Health Organzation, Global report on diabetes .Geneva 2016
- Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.
- Rogers LC, Frykberg RG, Armstrong DG, Boulton AJ, Edmonds M, Van GH, Hartemann A, Game F, Jeffcoate W, Jirkovska A, Jude E, Morbach S, Morrison WB, Pinzur M, Pitocco D, Sanders L, Wukich DK, Uccioli L. The Charcot foot in diabetes. Diabetes Care. 2011 Sep;34(9):2123-9. doi: 10.2337/dc11-0844.
- Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003 May;26(5):1435-8. doi: 10.2337/diacare.26.5.1435.
- Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.
- El-Mowafi H, Abulsaad M, Kandil Y, El-Hawary A, Ali S. Hybrid Fixation for Ankle Fusion in Diabetic Charcot Arthropathy. Foot Ankle Int. 2018 Jan;39(1):93-98. doi: 10.1177/1071100717735074. Epub 2017 Oct 16.
- 8-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.
- Brodsky JW. Management of Charcot joints of the foot and ankle in diabetes. Semin Arthroplasty. 1992; 3: 58-62.
- Brodsky JW. Patterns of breakdown in the Charcot tarsus of diabetics and relation to treatment. Foot and Ankle 1986;5:353.
- Lowery NJ, Woods JB, Armstrong DG, Wukich DK. Surgical management of Charcot neuroarthropathy of the foot and ankle: a systematic review. Foot Ankle Int. 2012 Feb;33(2):113-21. doi: 10.3113/FAI.2012.0113.
- Anthony S., Pomeroy G. (2016) Exostectomy for Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
- Tan E.W., Schon L.C. (2016) Plate Fixation Techniques for Midfoot and Forefoot Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
- Use of External Fixation for the Management of the Diabetic Foot and AnkleDO - 10.1007/978-3-319-27623-6_13 - The Surgical Management of the Diabetic Foot and Ankle
- Ramanujam CL, Zgonis T. Surgical Correction of the Achilles Tendon for Diabetic Foot Ulcerations and Charcot Neuroarthropathy. Clin Podiatr Med Surg. 2017 Apr;34(2):275-280. doi: 10.1016/j.cpm.2016.10.013. Epub 2016 Dec 30. Review.
- Gentili A, Masih S, Yao L, Seeger LL. Pictorial review: foot axes and angles. Br J Radiol. 1996 Oct;69(826):968-74. doi: 10.1259/0007-1285-69-826-968.
- Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.
- 18-Abetz L, Sutton M, Brady L, McNulty P, Gagnon DD. The diabetic foot ulcer scale (DFS): a quality of life instrument for use in clinical trials. Prac Diabetes Int. 2002;19:167-175.
- Robinson AH, Pasapula C, Brodsky JW. Surgical aspects of the diabetic foot. J Bone Joint Surg Br. 2009 Jan;91(1):1-7. doi: 10.1302/0301-620X.91B1.21196.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Deformity in Charcot foot
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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