Clinical Trial: Characterization of the Charcot Foot
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: Follow-up on Cross-sectional Study of Known Population With Charcot Osteoarthropathy - Metabolic, Physiologic and Pathologic Changes
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 Summary: please see above
Sponsor: Bispebjerg Hospital
Current Primary Outcome: Disease progression in the previously affected foot [ Time Frame: initiation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Bone mineral density of os. calcaneus [ Time Frame: initiation ]
- Peripheral neuropathy in the feet [ Time Frame: initiation ]
- Peripheral blood supply [ Time Frame: initiation ]
- Altered levels of bone resorption markers [ Time Frame: initiation ]
Original Secondary Outcome: Same as current
Information By: Bispebjerg Hospital
Dates:
Date Received: June 27, 2014
Date Started: September 2014
Date Completion: July 2017
Last Updated: January 11, 2016
Last Verified: January 2016
