跳至主要内容
临床试验/CTRI/2021/03/032248
CTRI/2021/03/032248已完成不适用

A study to compare the effectiveness of Topical insulin Vs Honey dressing on Diabetic foot ulcer among patients with Diabetic mellitus residing in Urban and Rural population, Erode.

Mrs Chandramathi K1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Wound healing after intervening topical insulin and honey dressing will be the primary outcome of this study.

研究概览

简要总结

This study was a randomized, blocked RCT superiority trial, comparing the efficacy of topical insulin Vs honey dressing on diabetic foot ulcer among patients with diabetes mellitus residing in urban and rural population in experimental arm I, III & II, IV.

In Topical insulin dressing5 units of human actrapid insulin was diluted with 1 ml of normal saline and sprayed  into diabetic foot ulcer.. After 5 minutes dry gauze covered over the diabetic foot ulcer. This dressing was applied for 30 minutes once a day for one month.

In Honey dressing commercially purchased 1 ml of honey was poured into sterile bowl and thin layer of gauze is soaked in honey. Soaked honey gauze topically applied over the diabetic foot ulcer as a thin layer. After 5 minutes dry gauze covered over the diabetic foot ulcer. This dressing was applied for 30 minutes once a day for one month.

Topical insulin and honey dressing was applied for 30 minutes once a day for one month.

Wagner Classification of diabetic foot ulcer and Bates Jensen wound assessment tool was used to assess the diabetic foot ulcer in experimental Arm I, II, III and IV.

two Post-test were conducted after intervening topical insulin Vs honey dressing by adopting Bates Jensen wound assessment tool, at the end of day 15 and 30 among patients with Diabetes mellitus in urban and rural populations in experimental Arm I, II, III and IV respectively

Level of diabetic foot ulcer was majority of patients were wound regeneration in pre-test after application of topical insulin and honey dressing, in post-test the level of diabetic foot ulcer were in mild wound healthy, comparing pre-test score in topical and honey dressing the post-test score level was reduced so both the dressing were effective but comparing topical insulin dressing the honey dressing was very effective.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria: Patients with Diabetic mellitus Age group between 30 and 65 years With grade 1 and 2 ulcers selected by using Wagner classification of diabetic foot ulcer Who are willing to participate in the study.

排除标准

  • Exclusion Criteria: Patients with Diabetic mellitus Absence of peripheral pulse in dorsalis pedis artery, posterior tibial artery, anterior tibial artery Uncontrolled wound bleeding Severe malnutrition assessed by BMI Anemia and Hypo-proteinemia Severe infection & Burns Immunodeficiency diseases Renal failure Liver dysfunction Ischemic limbs Osteomyelitis Varicose ulcer.

结局指标

主要结局

Wound healing after intervening topical insulin and honey dressing will be the primary outcome of this study.

时间窗: Mean Bates wound assessment scale, Time point- 4 weeks | Wound healing after intervening topical insulin and honey dressing will be the primary outcome of this study.

次要结局

  • Mean Bates wound assessment scale(Time point- 4 weeks)

研究者

发起方
Mrs Chandramathi K
申办方类型
Other [self]

研究点 (1)

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