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The effect of Vitamin C for healing of diabetic foot ulcer

Phase 3
Recruiting
Conditions
Diabetic foot ulcer.
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Registration Number
IRCT20210315050706N2
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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