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临床试验/CTRI/2025/07/090902
CTRI/2025/07/090902尚未招募2 期

Effectiveness of topical Insulin in Diabetic Foot Ulcer compared to normal saline dressing among inpatients of a tertiary health centre: A randomized control trial

Indira Gandhi medical College and research institute1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
84
试验地点
1
主要终点
parameters : based on bates jenson score

研究概览

简要总结

all the consented participants will be admitted and would undergo the following investigations. Complete blood count, Fasting, postprandial blood sugar ,LFT , RFT , HbA1C , Doppler, X-ray , wound swab / pus culture sensitivity. Initial wound debridement (if needed) - removal of necrotic debris, slough, foreign body will be done. Patients will be selected by consecutive sampling , randomized into two groups by block randomization and allocation concealment will be done by SNOSE technique.Initial wound assessment will be done before randomization by the principle investigator. Both the groups will be started on empirical intravenous antibiotics (cefotaxime and metronidazole) which will be modified after the culture sensitivity reports, will receive same Diabetic diet from hospital, and their diabetic medications (such that blood glucose values are controlled).No intervention will be done for the systemic disease of the patient. Patients will be receiving daily dressing : test group will be receiving insulin dressing and the control group will be receiving normal saline dressing . The dressing solutions will be freshly prepared and opaque containers will be used. Periodical wound assessment will be done during the hospital stay using bates jenson wound assessment tool. Once the wound is healed or after two weeks (whichever is earlier) , the patient will be discharged.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adult individuals (age 18 and above) diagnosed with diabetes(Type 1 and 2).
  • Willingness to participate and provide informed consent.
  • Grade 1 and 2 of diabetic ulcer (Wagner-Meggitt classification).

排除标准

  • Patients with previous surgery for diabetic foot earlier b.
  • Allergic reactions or contraindications to insulin.
  • Non-compliance with the treatment plan d.
  • X-ray features of osteomyelitis e.
  • Doppler showing gross atherosclerotic changes and venous abnormalities f.
  • Other clinically significant medical conditions that would impair wound healing (renal, hepatic, immunodeficiency, hematological, neurological diseases and malignancies) g.
  • patients in intensive care unit.

结局指标

主要结局

parameters : based on bates jenson score

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

size of the ulcer

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

depth

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

edge

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

necrotic tissue

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

exudate

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

undermining of edges

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

peripheral tissue edema , induration

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

granulation tissue

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

epithelialization .

时间窗: day 2, day 4, day 6, day 8, day 10, day 12 , day 14.

次要结局

  • Difference in rate of healing between saline & insulin(At 2nd 4th 6th 8th 10th 12th 14th day)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Porshiya

Indira Gandhi medical College and research institute

研究点 (1)

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