Characterization of the Charcot Foot

NCT ID: NCT02335931

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-07-31

Brief Summary

The project concerns a type of very debilitating diabetic foot complications called Charcots osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of the load bearing joints, primarily in the feet, resulting in loss of structure and remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain and walking disability for the patient. Reconstruction is often very difficult or impossible, and furthermore the collapse can lead to chronic foot ulcers and infections, which in the worst case can be fatal.

Treatment options are currently limited to early diagnosis and physical offloading (immobilisation), assisted wound healing and surgical intervention.

The purpose of this project is to investigate and describe the bone-related factors, which separate COA from other, less acute, diabetic foot changes. The investigators wish to describe the long term consequences of COA - both anatomically, physiologically and biochemically.

The investigators will be doing this in a follow-up investigations on a group of COA patients tested 8 years ago. Little is known of the long term changes to the bone structure after acute COA, and the investigators want to visualize to what extend the bone damage is permanent.

To do this the investigators will be using DXA-scans, x-ray, blood tests including bone markers, neurophysiological tests and occlusion plethysmography.

Detailed Description

please see above

Conditions

Charcot's Joint; Complications of Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Charcot foot

Patients with Charcot foot and diabetes mellitus 1 or 2

No interventions assigned to this group

No charcot foot

patients with diabetes mellitus type 1 or 2

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Followed in the previous study

Exclusion Criteria

• Unable to attend follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rasmus Bo Jansen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rasmus B Jansen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg Hospital

København NV, , Denmark

Countries

Denmark

Other Identifiers

H-1-2014-055

Identifier Type: -

Identifier Source: org_study_id