Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Wound Heal

Treatments: Drug: Selenium; Drug: Cilostazol

Study type: Interventional

Funder types: Other

Identifiers

NCT06117436

CSDFU81

Details and patient eligibility

About

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 to find a novel intervention that improve wound healing in diabetic foot ulcer to improve patients' quality of life, reduce amputation rate, and reduce the mortality rate among diabetic foot ulcer patients

Enrollment: 206 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

1. Wagner's grade 5 patients (because of the indications for amputation).
2. Patients with poor glycemic control at the time of inclusion (HbA1c>12%).
3. Patients who need either direct graft or indirect revascularization procedure during the study.
4. Patients with Cilostazol or Selenium allergy.
5. Patients with Cilostazol contraindications (Heart Failure, bleeding disorder).
6. Patients with a history of comorbidities that interfere with wound healing (cancers, congestive heart failure, end-stage renal disease, and liver failure).
7. Presence of clinical signs of active infection unresponsive to oral antibiotics (oedema, erythema, discharge, regional lymph node enlargement, pain, or fever).
8. Patients who take medications that interfere with wound healing (glucocorticoids, immunosuppressive and cytotoxic drugs) at the time of inclusion.
9. Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 3 patient groups

Control Group

No Intervention group

Description:

patients will receive standard wound care and diabetes management (that includes bed rest with elevation, antibiotics, analgesics, and dressings).

Cilostazol Group

Active Comparator group

Description:

patients will receive Cilostazol 100 mg tablets per oral once daily in addition to standard wound care and diabetes management.

Treatment:

Drug: Cilostazol

Cilostazol & Selenium Group

Active Comparator group

Description:

Cilostazol 100 mg tablets plus Selenium 200 mcg tablets per oral once daily, in addition to standard wound care and diabetes management.

Treatment:

Drug: Cilostazol

Drug: Selenium