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OpenTrials
Completed

NCT Number: NCT06117436

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

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

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Key information

Conditions

Wound Heal

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National Institute of Diabetes and Endocrinology

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Cilostazol

Drug

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

Other names: cilosort

selenium

Drug

Selenium 200 mcg oral tablet once daily

Primary outcomes

  1. Wound Healing size

    Time frame: 3 months

    ulcer length, width, and depth in Cm

Secondary outcomes

  1. Effect on Matrix Metalloproteinase-9 (MMP-9) level

    Time frame: 3 months

    will be used by ELISA Kit

  2. Occurrence of infection

    Time frame: 3 months

    any symptoms of infection Include (Redness, Edema and pain at the site of infection)

  3. Treatment-related side effects.

    Time frame: 3 months

    by asking the patient by phone call

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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