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

NCT06117436 | Completed Phase 2

• 1 other identifier: CSDFU81
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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 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

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Wound Healing size

  ulcer length, width, and depth in Cm

  3 months

Secondary Outcomes (3)

• Effect on Matrix Metalloproteinase-9 (MMP-9) level

  3 months

• Occurrence of infection

  3 months

• Treatment-related side effects.

  3 months

Study Arms (3)

Control Group

NO INTERVENTION

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

Cilostazol Group

ACTIVE COMPARATOR

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

Drug: Cilostazol

Cilostazol & Selenium Group

ACTIVE COMPARATOR

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

Drug: Cilostazol; Drug: Selenium

Interventions

Cilostazol DRUG

Cilostazol 100 MG oral tablet once daily antiplatelet, Selenium 200mcg tablet once daily, anti oxidant

Also known as: cilosort

Cilostazol & Selenium Group; Cilostazol Group

Selenium DRUG

Selenium 200 mcg oral tablet once daily

Cilostazol & Selenium Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Wagner's grade 5 patients (because of the indications for amputation).
• 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).
• Non-diabetic patients with foot wounds due to vascular or dermatological reasons.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

National Institute of Diabetes and Endocrinology

Cairo, Egypt

Location

Related Publications (1)

• Eliwa HE, Wakeel LME, Mahfouz AA, Sayed R. Impact of Cilostazol versus Cilostazol and Selenium Combination on The Healing of Diabetic Foot Ulcer Patients: ARandomized Controlled Trial. Diabetol Metab Syndr. 2026 Jan 6. doi: 10.1186/s13098-025-02053-4. Online ahead of print. No abstract available.

  PMID: 41495844 DERIVED

MeSH Terms

Interventions

Cilostazol; Selenium

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 7, 2023
• Study Start: October 19, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

EG (1)