Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157222
Status:
UNKNOWN
Last Update Posted:
2005-12-08
First Post:
2005-09-08
Brief Title:
Characterizing and Diagnosiss of the Charcot Foot Charcot Osteoarthropathy in Diabetic Patients
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Characterizing and Diagnosiss of the Charcot Foot Charcot Osteoarthropathy in Diabetic Patients
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The condition Charcot foot has been known in more than 130 years and yet there still remains a large effort to find the cause diagnostic and medical treatment of the condition
Charcot neuroarthropathy is a progressive disease of bone and joints characterized by often-painless bone and joint destruction in limbs that have lost sensory innervation The incidence of acute Charcot among diabetic patients is 02 the prevalence is 75 In the group of patients with neuropathy the prevalence is even higher -29
The diagnosis is often made on a clinical basis particularly in the early stages of the condition The aim of this study is to find a method that makes the diagnosis primarily on the basis of paraclinical information
Clinical presentation
The typical patients have had diabetes in 10 years and have distal symmetrical neuropathy
The common lesion is unilateral with an acute phase which may occur either spontaneously or be triggered by a minor trauma The foot becomes swollen warm red and oedematous Some patients have pain and the condition could be misdiagnosed as cellulites acute gout deep vein thrombosis and osteomyelitis If the patient has a foot ulcer it is important to rule out osteomyelitis and cellulites
In the initial phase it is difficult to make the right diagnose because Charcot is a rare condition This leads to a delay in the treatment of the Charcot foot which for the moment is reduction of weight bearing The patient is equipped with an air cast and the non weight-bearing regime is in some cases maintained in 12 months
The chronic Charcot is characterized by established deformity The deformity can be in different sites in the foot the most common is in the mid foot Because of the deformity there is abnormal weight pressure on the weight bearing sites on the foot This is associated with callus formation and there is a higher risk for ulceration
Charcot neuroarthropathy is a progressive disease of bone and joints characterized by often-painless bone and joint destruction in limbs that have lost sensory innervation The incidence of acute Charcot among diabetic patients is 02 the prevalence is 75 In the group of patients with neuropathy the prevalence is even higher -29
The diagnosis is often made on a clinical basis particularly in the early stages of the condition The aim of this study is to find a method that makes the diagnosis primarily on the basis of paraclinical information
Clinical presentation
The typical patients have had diabetes in 10 years and have distal symmetrical neuropathy
The common lesion is unilateral with an acute phase which may occur either spontaneously or be triggered by a minor trauma The foot becomes swollen warm red and oedematous Some patients have pain and the condition could be misdiagnosed as cellulites acute gout deep vein thrombosis and osteomyelitis If the patient has a foot ulcer it is important to rule out osteomyelitis and cellulites
In the initial phase it is difficult to make the right diagnose because Charcot is a rare condition This leads to a delay in the treatment of the Charcot foot which for the moment is reduction of weight bearing The patient is equipped with an air cast and the non weight-bearing regime is in some cases maintained in 12 months
The chronic Charcot is characterized by established deformity The deformity can be in different sites in the foot the most common is in the mid foot Because of the deformity there is abnormal weight pressure on the weight bearing sites on the foot This is associated with callus formation and there is a higher risk for ulceration
Detailed Description:
Method
The investigation is a case control study where the aim is to test a set off clinical tests to see if the diagnose Charcot foot can be made paraclinical The assumption is that there are other parameter than the clinical observation that differ between the Charcot patient and a patient with polyneuropathy
The study will consist of a variety of examinations All patients will undergo a clinical examination by the same physician including a neurological status
The paraclinical examinations consist of blood samples x-ray of the foot if normal then MR-scanning of the foot skeletal Scintigraphy DEXA scanning distal blood pressure beat to beat examination to decide the autonomous neuropathy If the patient has a positive skeletal scintigraphy and ulceration on the foot or elevated infection parameter in the blood sample then a leukocyte scintigraphy will be performed in order to rule out osteomyelitis
The population that we will include in the study is divided in 5 groups
1 Patients with diabetes and acute Charcot foot
2 Patients with diabetes and chronic Charcot foot
3 Patients with diabetes and amputation of the first toe
4 Patients with diabetes and polyneuropathy
5 Patients with diabetes and without polyneuropathy All patients will undergo the full examination program with the exception of the cases mentioned above
Conclusions
There is need for a better diagnostic of the condition Charcot foot due to the severe longtime complication in form of disablement In some cases even amputation of the foot If the diagnosis is made earlier obviously one can start the intervention earlier and this will improve the survival of the foot
Another advantage is that agreed criteria for the diagnosis of Charcot would help in allowing comparison of different treatments
The investigation is a case control study where the aim is to test a set off clinical tests to see if the diagnose Charcot foot can be made paraclinical The assumption is that there are other parameter than the clinical observation that differ between the Charcot patient and a patient with polyneuropathy
The study will consist of a variety of examinations All patients will undergo a clinical examination by the same physician including a neurological status
The paraclinical examinations consist of blood samples x-ray of the foot if normal then MR-scanning of the foot skeletal Scintigraphy DEXA scanning distal blood pressure beat to beat examination to decide the autonomous neuropathy If the patient has a positive skeletal scintigraphy and ulceration on the foot or elevated infection parameter in the blood sample then a leukocyte scintigraphy will be performed in order to rule out osteomyelitis
The population that we will include in the study is divided in 5 groups
1 Patients with diabetes and acute Charcot foot
2 Patients with diabetes and chronic Charcot foot
3 Patients with diabetes and amputation of the first toe
4 Patients with diabetes and polyneuropathy
5 Patients with diabetes and without polyneuropathy All patients will undergo the full examination program with the exception of the cases mentioned above
Conclusions
There is need for a better diagnostic of the condition Charcot foot due to the severe longtime complication in form of disablement In some cases even amputation of the foot If the diagnosis is made earlier obviously one can start the intervention earlier and this will improve the survival of the foot
Another advantage is that agreed criteria for the diagnosis of Charcot would help in allowing comparison of different treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None