Personalized nutrition to improve wound healing in diabetic patients
Evaluation of Personalized Nutritional Intervention Together With the Application of MSC-derived Exosomes on the Regenerative Capacity and Wound Healing of Cutaneous Ulcers in Diabetics
This study tests if personalized nutrition can help diabetic patients heal their chronic wounds better and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba Academic / other |
| Locations | 1 site (Córdoba, Andalucía) |
| Trial ID | NCT05243368 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of personalized nutritional interventions on the healing of chronic cutaneous ulcers in diabetic patients. The study recognizes that malnutrition is a significant risk factor for poor wound healing in diabetics and seeks to correct nutritional deficiencies to create a more favorable healing environment. By utilizing exosomes derived from stem cells, the intervention aims to enhance tissue regeneration and accelerate the healing process. Participants will receive tailored nutritional support based on their individual needs to improve their overall healing outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are diabetic patients aged 50 to 80 years with chronic cutaneous ulcers and documented peripheral artery disease.
Not a fit: Patients with conditions such as osteomyelitis, gangrene, or those who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance wound healing in diabetic patients, reducing complications and improving quality of life.
How similar studies have performed: While the approach of using personalized nutrition in wound healing is gaining attention, this specific intervention combining nutritional support with exosome therapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Córdoba, Andalucía
- Hospital Universitario Reina Sofía de Córdoba — Córdoba, Andalucía, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Casado-Díaz, PhD — Maimonides Biomedical Research Institute of Cordoba
- Study coordinator: Antonio Casado-Díaz, PhD
- Email: bb1cadia@uco.es
- Phone: 957213814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.