Status:
UNKNOWN
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Collaborating Sponsors:
Instituto de Salud Carlos III
Hospital Universitario Reina Sofia de Cordoba
Conditions:
Foot, Diabetic
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
The ageing population and the increase in diabetes raise the prevalence of chronic skin ulcers (CCU). In diabetics, precursor cell mobilization decreases. In wounds, the inflammation is prolonged and ...
Eligibility Criteria
Inclusion
- Signature of the informed consent
- Age between 50 and 80 years
- Diagnosis of Diabetes Mellitus for more than 1 year
- Documented diagnosis of peripheral artery disease
- HbA1c \< 9%
- Category 5 in the Rutherford-Becker classification
Exclusion
- Poor cognitive function, dementia or psychiatric conditions
- Osteomyelitis, gangrene, malignancy or immunocompromised disease
- Thromboangiitis obliterans or Buerger's disease
- Clinical evidence of invasive infection in the target limb requiring IV antibiotherapy
- Presence of neuropathic ulcers only
- Human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05243368
Start Date
October 20 2023
End Date
December 31 2024
Last Update
October 25 2023
Active Locations (1)
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1
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Andalusia, Spain, 14004