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Characterization of the Charcot Foot

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02335931
Enrollment
21
Registered
2015-01-12
Start date
2014-09-30
Completion date
2017-07-31
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Charcot's Joint, Complications of Diabetes Mellitus

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

Interventions

None listed

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Followed in the previous study

Exclusion criteria

* Unable to attend follow-up

Design outcomes

Primary

MeasureTime frame
Disease progression in the previously affected footinitiation

Secondary

MeasureTime frame
Bone mineral density of os. calcaneusinitiation
Peripheral neuropathy in the feetinitiation
Peripheral blood supplyinitiation
Altered levels of bone resorption markersinitiation

Other

MeasureTime frame
Amputationsinitiation
Diabetes regulationinitiation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026