Characterization of the Charcot Foot

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

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.

Study Overview

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

Detailed Description

please see above

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Denmark
  • København NV, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Follow-up study, population of patients referred with charcot foot 8 years ago. Control population without Charcot foot, taken from the outpatient clinic.

Description

Inclusion Criteria:

• Followed in the previous study

Exclusion Criteria:

• Unable to attend follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Charcot foot; Patients with Charcot foot and diabetes mellitus 1 or 2
No charcot foot; patients with diabetes mellitus type 1 or 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease progression in the previously affected foot	initiation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Amputations	initiation
Diabetes regulation	initiation

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Rasmus B Jansen, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Joint Diseases; Musculoskeletal Diseases; Diabetes Complications; Arthropathy, Neurogenic
• Other Study ID Numbers: H-1-2014-055