Characterization of the Charcot Foot

NCT02335931 | Completed

• 1 other identifier: H-1-2014-055
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Charcot's Joint; Complications of Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Disease progression in the previously affected foot

  initiation

Secondary Outcomes (4)

• 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 Outcomes (2)

• Amputations

  initiation

• Diabetes regulation

  initiation

Study Arms (2)

Charcot foot

Patients with Charcot foot and diabetes mellitus 1 or 2

No charcot foot

patients with diabetes mellitus type 1 or 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Followed in the previous study

You may not qualify if:

• Unable to attend follow-up

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

København NV, 2400, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen full blood samples

MeSH Terms

Conditions

Arthropathy, Neurogenic; Diabetes Complications

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Rasmus B Jansen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: January 12, 2015
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

DK (1)