Charcot JointNCT00157222
Characterizing and Diagnosis's of the Charcot Foot (Charcot Osteoarthropathy) in Diabetic Patients
An observational study of Charcot Joint and Diabetic Foot, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Charcot Joint, Diabetic Foot
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2005to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute Charcot
- Chronic Charcot
- Polyneuropathy
- Operation of the foot
Who cannot join
- Pregnancy
- Infection of the foot
- Impert blood flow in the leg.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, 2200
tomas m Christensen, m.d, +45 35316661, tc12@bbh.hosp.dk
About this study
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 0,2 % the prevalence is 7,5 %. In the group of patients with neuropathy the prevalence is even higher -29%.
Read more
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.
Read the 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:
- Patients with diabetes and acute Charcot foot.
- Patients with diabetes and chronic Charcot foot.
- Patients with diabetes and amputation of the first toe.
- Patients with diabetes and polyneuropathy.
- 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.
- Conditions
- Charcot Joint, Diabetic Foot
- Keywords
- Charcot, Diabetic, osteoporosis
- Medical subject headings
- Arthropathy, Neurogenic, Diabetic Foot, Osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMay 2005
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, The Danish Diabetes Association, Clinical and basic research ballerup, Steno Diabetes Center Copenhagen
- Investigators
- Ole L Svendsen, M.D, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157222
- Sponsor's protocol ID
- (KF) 01 2587558
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 8 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing and Diagnosis's of the Charcot Foot (Charcot Osteoarthropathy) in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00157222
- Acronym / sponsor ID
- (KF) 01 2587558
- Conditions
- Charcot Joint, Diabetic Foot
- Keywords
- Charcot, Diabetic, osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, The Danish Diabetes Association, Clinical and basic research ballerup, Steno Diabetes Center Copenhagen
- Study start
- May 2005
- Study completion
- Apr 2008
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 0,2 % the prevalence is 7,5 %. 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:
- Patients with diabetes and acute Charcot foot.
- Patients with diabetes and chronic Charcot foot.
- Patients with diabetes and amputation of the first toe.
- Patients with diabetes and polyneuropathy.
- 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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Acute Charcot
- Chronic Charcot
- Polyneuropathy
- Operation of the foot
Key exclusion criteria (3 listed)
- Pregnancy
- Infection of the foot
- Impert blood flow in the leg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole L Svendsen, M.D principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Charcot Joint and Diabetic Foot, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas, m Christensen, M.D (+45 35316661, tc12@bbh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2005.