Characterization of the Charcot Foot

Completed

• Conditions: Charcot's Joint; Complications of Diabetes Mellitus

• Registration Number: NCT02335931
• Lead Sponsor: Bispebjerg Hospital

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

Study Timeline

• Study First Submitted: 2014-06-27
• Study Start: 2014-09
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2017-01
• Study Completion: 2017-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-28
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Followed in the previous study

Exclusion Criteria

• Unable to attend follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression in the previously affected foot	initiation

Secondary Outcome Measures

Name	Time	Method
Peripheral neuropathy in the feet	initiation
Altered levels of bone resorption markers	initiation
Bone mineral density of os. calcaneus	initiation
Peripheral blood supply	initiation

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 København NV, Denmark