Status:
COMPLETED
Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
Lead Sponsor:
Ain Shams University
Conditions:
Wound Heal
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The growing incidence of DM can lead to the increased prevalence of diabetic foot complications, which have become a serious medical, social, and economic concern of global importance. this study aims...
Eligibility Criteria
Inclusion
- Eligible patients will be adult diabetic patients aged 18 years and older with non-ischemic diabetic foot ulcers Wagner's grade 2, 3, and 4.
Exclusion
- Wagner's grade 5 patients (because of the indications for amputation).
- Patients with poor glycemic control at the time of inclusion (HbA1c\>12%).
- Patients who need either direct graft or indirect revascularization procedure during the study.
- Patients with Cilostazol or Selenium allergy.
- Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).
- Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure).
- Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever).
- Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion.
- Non-diabetic patients with foot wounds due to vascular or dermatological reasons.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06117436
Start Date
October 19 2023
End Date
January 30 2025
Last Update
February 18 2025
Active Locations (1)
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1
National Institute of Diabetes and Endocrinology
Cairo, Egypt