Characterization of the Charcot Foot

Complications of Diabetes Mellitus Clinical Trial

Official title:

Follow-up on Cross-sectional Study of Known Population With Charcot Osteoarthropathy - Metabolic, Physiologic and Pathologic Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335931
• Other study ID #: H-1-2014-055
• Status: Completed
• Start date: September 2014
• Est. completion date: July 2017

Study information

• Verified date: March 2020
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

please see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Followed in the previous study

Exclusion Criteria:

• Unable to attend follow-up

Related Conditions & MeSH terms

• Arthropathy, Neurogenic
• Charcot's Joint
• Complications of Diabetes Mellitus
• Diabetes Complications

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	København NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Amputations		initiation
Other	Diabetes regulation		initiation
Primary	Disease progression in the previously affected foot		initiation
Secondary	Bone mineral density of os. calcaneus		initiation
Secondary	Peripheral neuropathy in the feet		initiation
Secondary	Peripheral blood supply		initiation
Secondary	Altered levels of bone resorption markers		initiation