CTRI/2019/06/019714尚未招募未知
Vitamin D supplements in diabetic foot infection: a prospective observational study in a tertiary healthcare facility
Manipal McGill Center for Infectious Diseases0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Confirmed diagnosis of DM type 1 or 2.
- •2.Presence of 1 or more DFU, less than 15 cm in
- •its biggest diameter, with a Texas University
- •score <= 2. (For DFU patients)
- •3.Low Serum vitamin D level (Cohort study)
- •4.Prescribed with oral vitamin D supplements
- •about the equivalent to 3,300 IU/day for 3
- •months (Study Cohort)
- •5.Clinical evidence of foot infection diagnosed
- •by culture positivity and/or leucocytes in the
- •presence of fever. [For diabetic foot infection
- •(DFI) patients]
- •6.Pharmacological treatment for both glycemic
- •control and foot infection.
- •7.Willingness to participate in the study and to
- •give the informed consent form.
排除标准
- •1.Unconfirmed DM diagnosis.
- •2.Any pathology that, based on the judgment of
- •the researcher, could alter the course of DFU
- •(neoplasias, immunological disorders, etc).
- •3.Renal insufficiency requiring dialysis
- •4.DFU with a Texas score >2.
- •5.Critical ischemia of IL diagnosed by Doppler
- •ultrasound and defined by ankle/arm index
- •6.Clinical findings suggesting complicated venous
- •insufficiency of IL.
- •7.Distal necrosis of the limb with the ulcer.
- •8.Pregnant or breastfeeding women.
- •9.Mentally or neurologically disabled patients
- •that are considered not fit to approve their
- •participation in the study.
- •10.Patients having clinical evidence of vascular
- •insufficiency or taking immunosuppressants,
- •multivitamins, Ca supplements and drugs that
- •interfere with vitamin D metabolism were
- •excluded from the study. (Cohort study)
- •11.Unwilling to give informed consent.
研究者
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