Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06117436
Other study ID # CSDFU81
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 19, 2023
Est. completion date December 3, 2025

Study information

Verified date November 2023
Source Ain Shams University
Contact Hadeer Eid Eliwa, master
Phone 01000617696
Email hadeir.eid@fue.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 3, 2025
Est. primary completion date December 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt National Institute of Diabetes and Endocrinology Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound Healing size ulcer length, width, and depth in Cm 3 months
Secondary Effect on Matrix Metalloproteinase-9 (MMP-9) level will be used by ELISA Kit 3 months
Secondary Occurrence of infection any symptoms of infection Include (Redness, Edema and pain at the site of infection) 3 months
Secondary Treatment-related side effects. by asking the patient by phone call 3 months
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Completed NCT03285542 - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty N/A
Recruiting NCT05474911 - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. N/A
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04849143 - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation N/A
Completed NCT03596112 - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care N/A
Recruiting NCT05169814 - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds Early Phase 1
Completed NCT04545476 - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities N/A
Completed NCT06020157 - Comparison of Simple and Continuous Suture Techniques in Oral Surgery N/A
Recruiting NCT05133570 - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Withdrawn NCT03668665 - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" Phase 3
Completed NCT03703479 - Effect of A-PRF After Removal of Wisdom Teeth N/A
Recruiting NCT03204851 - Microlyte Dressing in the Management of Wounds N/A
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A
Completed NCT05252260 - Comparison of Diode Laser-Assisted Vestibuloplasty And Conventional Vestibuloplasty N/A