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临床试验/CTRI/2025/07/090972
CTRI/2025/07/090972尚未招募不适用

Assessment of Vitamin D levels in patients with Neuropathic Diabetic Foot Ulcers and its correlation with SINBAD score at index presentation

Dr Samridhi Agrawal1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Quantifying the Vitamin D deficiency in patients with neuropathic diabetic foot ulcers.

研究概览

简要总结

The study is a prospective cross-sectional study that will be conducted in the Department of General Surgery, Kasturba Hospital, Manipal. The study will undergo approval by the Institutional Ethics Committee. Informed consent will be taken from the participants at the time of enrolment from all the willing participants in the General Surgery OPD. Study population will include patients with non- infected neuropathic diabetic foot ulcers and relevant history and examination will be conducted to screen for inclusion and exclusion criteria. The ulcer will be examined and scored on the basis of SINBAD system Site, Ischemia, Neuropathy, Bacterial infection, Area, Depth. Serum Vitamin D levels which have been sent by the consultants as a routine protocol will be noted. Blood drawn for other lab investigations will suffice for Vitamin D level assessment also. No additional blood will be drawn separately for Vitamin D level assessment, which is a standard protocol for patients with diabetic neuropathy and reports will be collected from lab viewer. As per prior studies in the Department, the Podiatry Clinic of our Department does Vitamin D levels as a routine practice for all patients with Diabetic Neuropathy, without incurring additional costs. The severity of Vitamin D deficiency will be classified as per US Endocrine Society Classification, compared to the ulcer severity score. Finally, a correlation will be established between Vitamin D and the wound severity score. A p value of <0.05 will be considered statistically significant. The patient will be assessed during the index visit for diabetic foot ulcer and no follow up will be required.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more than or equal to 18 years with type 2 diabetes mellitus
  • Presence of non-infected neuropathic diabetic foot ulcer.

排除标准

  • 1.Patients with infected diabetic foot ulcers Any two or more of the following) a)Local swelling or induration b)Erythema 0.5-2.0 cm around ulcer c)Local tenderness or pain d)Local warmth e)Purulent discharge (thick, opaque to white, or sanguineous)
  • Non-neuropathic ulcers (e.g., venous, arterial, pressure ulcers).
  • Patients with chronic kidney disease (CKD) stage 4 or 5
  • Patients on high-dose vitamin D supplementation (more than 2000 IU/day) in the past 6 months.
  • Patients with other conditions affecting Vitamin D metabolism (e.g., liver disease, hyperparathyroidism, kidney, or malignancy-related).

结局指标

主要结局

Quantifying the Vitamin D deficiency in patients with neuropathic diabetic foot ulcers.

时间窗: At baseline

次要结局

  • 1. Categorizing the patients with Neuropathic DFUs based on vitamin D deficiency, insufficiency, or sufficiency.

研究者

发起方
Dr Samridhi Agrawal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Samridhi Agrawal

Kasturba Medical College, MAHE, Manipal

研究点 (1)

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