Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02316483
• Date of registration: 09/12/2014
• Prospective Registration: No
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes
• Scientific title: Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes
• Date of first enrolment: December 2013
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02316483
• Study type: Observational

Countries of recruitment

Qatar

Contacts

• Name: Charbel Abi Khalil, MD
• Affiliation: Weill Cornell Medical College in Qatar

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Must provide informed consent

2. Must hold Qatari passport

3. Males or Females ages 30 years or older to minimize the potential confounding
contribution of other forms of diabetes mellitus

4. In patients with Diabetes, no concomitant diseases except for micro- and macrovascular
complications of diabetes (nephropathy, retinopathy, peripheral arterial disease,
coronary artery disease, neuropathy) or symptoms of the metabolic syndrome
(hypertension, dyslipidemia and obesity).

5. Not taking any chronic medications (except of the diabetes, cardiovascular related
drugs, anti-inflammatory drugs and/or any other treatment used for Charcot foot).

Exclusion Criteria:

1. Other forms of diabetes (Type I, MODY, secondary diabetes)

2. Active pregnancy

3. Active infection or acute illness of any kind (except for Charcot foot)

4. Chronic inflammation (auto-immune diseases) or infection

5. Evidence of malignancy within the past 5 years

6. Chronic hematological disorders known to affect HBA1C results such as
hemoglobinopathies (e.g., sickle cell disease and thalassemia), increased red-cell
turnover (e.g., hemolytic anemia and spherocytosis)

7. Acute or critical limb ischemia.

8. Osteomyelitis

9. History of recent (within 6 months) immunosuppressive treatment including
corticosteroids and anti-TNF-alpha compounds.



Age minimum: 30 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Charcot Arthropathy

Type 2 Diabetes

Primary Outcome(s)

Assess the effect of initial methylation on kidney function in patients with type 2 diabetes mellitus, weather they have or not Charcot foot disease and for whom we have baseline kidney function, in a 2-year follow-up. [Time Frame: 6 months]

Charcot Foot's vascular complications [Time Frame: 6 months]

HBA1C >8.5% on total and gene-specific methylation. [Time Frame: 6 months]

Charcot foot in monocyte epigenetics [Time Frame: 6 months]

Secondary ID(s)

13-00031 [JIRB]

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Weill Cornell Medical College in Qatar

Hamad Medical Corporation