Diabetic foot ulcer. Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: Patients in the intervention group will use one slow-release capsule of vitamin C 500 mg daily for 8 weeks. Intervention 2: Control group: Patients in the control g
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound size (length and width). Timepoint: At the beginning of the study and 8 weeks after the start of the intervention. Method of measurement: Ruler or 3D camera. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life. Timepoint: At the beginning of the study and 8 weeks after the start of the intervention. Method of measurement: SF-36 questionnaire.;Percentage of complete wound healing. Timepoint: The beginning of the intervention until 16 weeks after the start of the intervention (8 weeks after the end of the intervention as a follow-up). Method of measurement: The percentage of wound size reduction compared to the initial size. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArmin Nazeri
Mashhad University of Medical Sciences
Outcome results
None listed