Phase
Condition
Diabetic Foot Ulcers
Ulcers
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages 35-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
DFU is classified as Wagner 1 -2 on the Wagner classification system.
Persons with type 1 or type 2 diabetes with a non-healing ulcer of at least 4 weeksduration.
If more than one non-healing wound is present, the largest of the wounds that isclassified as a Wagner 1- 2.
The index ulcer had to be clinically non-infected.
Ankle Brachial Index (ABI) greater than or equal to 0.7.
HemoglobinA1C (HbA1c) < 12
Index foot ulcer located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces).
Wound area (length x width) measurement between 2 cm2 and 20 cm2.
Non-use of drugs that may interfere with wound healing, such as corticosteroids,immunosuppressive agents, and cytotoxic agents.
No smoking, alcohol or drug addiction.
Approved, informed, signed consent.
Exclusion
Exclusion Criteria:
Previous consumption of vitamin E and C supplements.
Index ulcer has exposed tendons, ligaments, muscle, or bone.
Confirmed presence of osteomyelitis, or if osteomyelitis is suspected.
Patients with renal deficiency, hepatic failure, has known immune insufficiency andcancer.
Subject is pregnant or plans to become pregnant during the duration of the trial.
Patient's blood vessels are non-compressible for ABI testing.
Patient is known to have a psychological, developmental, physical, emotionaldisorders.
Received systemic corticosteroids or immunosuppressive agents.
Study Design
Connect with a study center
Alavi Hospital
Mashhad, Razavi Khorasan 9137913316
Iran, Islamic Republic ofActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.