The effect of Vitamin C for healing of diabetic foot ulcer and quality of life: a randomized, double-blind, placebo-controlled trial

Mashhad University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•Presence of diabetic foot ulcer; Wagner ulcer 1or 2 (classified according to the Wagner classification system)
•If more than one ulcer is present, the largest ulcer classified as Wagner 1 or 2 is selected
•The selected wound must be at least four centimeters away from a non-target wound and, according to the researcher, unlikely to merge with another wound within 8 weeks after randomization.
•A well-defined leg ulcer, circular or oval in shape (measurable with a simple ruler), located on the plantar, medial, or lateral surface of the foot (including all surfaces of the toes), and without bone exposure
•Measurement of wound area (length ? width) between 2 cm2 and 20 cm2
•The selected wound should not be clinically infected
•Ankle brachial index (ABI) greater than or equal to 0.7
•Palpable Dorsalis Pedis pulse in both legs
•Male or female between 18 and 80 years old
•Avoiding the use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressants, and cytotoxic agents
•Absence of gangrene, severe ischemia, and persistent fever over 38°C
•No smoking, alcohol or drug addiction
•Patient willingness and written informed consent to participate in the study and take study pills, but no other vitamin supplements, during the study. (Persons taking vitamin supplements were eligible after a two-month abstinence period)

•Previous use of vitamin C supplements
•Confirmed presence of osteomyelitis, or if osteomyelitis is suspected
•Patients with renal failure, liver failure, immune system failure, cancer and severe peripheral arterial disease
•The patient's blood vessels are non-compressible for ABI testing
•According to Sander's classification system, the patient should be diagnosed with active Charcot
•A patient with mental, developmental, physical and emotional disorders
•The individual's unwillingness to continue to cooperate during the study or if they have not completed their treatment
•Pregnancy or lactating

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