Characterizing and Diagnosis’s of the Charcot Foot (Charcot Osteoarthropathy) in Diabetic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
H. Lundbeck A/S
The Danish Diabetes Association
Clinical and basic research ballerup
Steno Diabetes Center
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00157222
First received: September 8, 2005
Last updated: December 7, 2005
Last verified: September 2005
  Purpose

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.


Condition
Charcot Joint
Diabetic Foot

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Characterizing and Diagnosis’s of the Charcot Foot (Charcot Osteoarthropathy) in Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Estimated Enrollment: 50
Study Start Date: May 2005
Estimated Study Completion Date: April 2008
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Charcot
  • Chronic Charcot
  • Polyneuropathy
  • Operation of the foot

Exclusion Criteria:

  • Pregnancy
  • Infection of the foot
  • Impert blood flow in the leg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157222

Contacts
Contact: Tomas, m Christensen, M.D +45 35316661 tc12@bbh.hosp.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2200
Contact: tomas m Christensen, m.d    +45 35316661    tc12@bbh.hosp.dk   
Sponsors and Collaborators
Bispebjerg Hospital
H. Lundbeck A/S
The Danish Diabetes Association
Clinical and basic research ballerup
Steno Diabetes Center
Investigators
Principal Investigator: Ole L Svendsen, M.D Bispebjerg Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157222     History of Changes
Other Study ID Numbers: (KF) 01 2587558
Study First Received: September 8, 2005
Last Updated: December 7, 2005
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Charcot
Diabetic
osteoporosis

Additional relevant MeSH terms:
Arthropathy, Neurogenic
Diabetic Foot
Joint Diseases
Musculoskeletal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 01, 2014