## Protocol Section
### Identification Module
**NCT ID:** NCT02386579

**Brief Title:** Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy

#### Organization Study ID Info
**ID:** H-1-2014-069
#### Organization
**Class:** OTHER
**Full Name:** Bispebjerg Hospital
### Status Module
#### Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-31

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-02

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2015-03-12
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-27
**Study First Submit QC Date:** 2015-03-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bispebjerg Hospital

#### Responsible Party

**Investigator Affiliation:** Bispebjerg Hospital

**Investigator Full Name:** Rasmus Bo Jansen

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow.

Patients will be compared with healthy diabetic controls.

### Conditions Module

**Conditions:**

- Arthropathy, Neurogenic

- Diabetes Complications

- Diabetes Mellitus

### Design Module

#### Bio Spec

**Description:** blood serum samples

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 5

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Blood sample measurements

**Label:** Diabetics with Charcot foot

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diabetics with Charcot foot

**Description:** Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water

**Name:** Blood sample measurements

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** RANKL

**Time Frame:** 10 min between measurements

#### Secondary Outcomes

**Measure:** osteocalcin

**Time Frame:** 10 min between measurements

**Measure:** CTX-I

**Time Frame:** 10 min between measurements

**Measure:** sRAGE

**Time Frame:** 10 min between measurements

**Measure:** P1NP

**Time Frame:** 10 min between measurements

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist

Exclusion Criteria:

* Osteoporosis
* Anti-osteoporotic treatment
* Lower extremity amputation
* Lower extremity infection

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Diabetes patients with and without acute charcot foot

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: HIGH

- As Found: Diabetes Complications

- ID: M4485

- Name: Arthropathy, Neurogenic

- Relevance: HIGH

- As Found: Arthropathy, Neurogenic

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001177

- Term: Arthropathy, Neurogenic

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000048909

- Term: Diabetes Complications

### Misc Info Module

- Version Holder: 2024-05-24
