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临床试验/NCT02241811
NCT02241811Unknown1 期

Deep Diabetic Foot Wound Treatment With Hydrogel Including 3% Sodium Pentaborate Pentahydrate

SB Istanbul Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
20
试验地点
1
主要终点
Wound healing, Complication

研究概览

简要总结

Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. This research is aim to observe the foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.

详细描述

Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. For these reason we prepared a hydrogel formulations.

Gel preparation:

Hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (Carbopol Ultrez-21, Lubrizol, USA) in distilled water. Neutralization buffer (1.6g of 1M sodium hydroxide solution for 1L polymer-water suspension) was used for the gelation of the polymer. Sodium pentaborate pentahydrate (3% w/v), F68 (2% w/v) and F127 (2% w/v) were mixed into the blank hydrogel and stored at 4 °C until it completely dissolved (approximately 24 h). pH of the hydrogel formulation was set to 6.5-7.0 using 1M sodium hydroxide. The hydrogel without any active ingredient was used as negative control (vehicle).

For the first group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate, and for the control group after wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic Foot wounds

排除标准

  • 未提供

研究组 & 干预措施

Control

Placebo Comparator

After wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.

干预措施: Placebo (Drug)

3% Sodium Pentaborate Pentahydrate

Experimental

For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.

干预措施: 3% Sodium Pentaborate Pentahydrate (Drug)

结局指标

主要结局

Wound healing, Complication

时间窗: 2 months

observation of wound healing and complications

次要结局

未报告次要终点

研究者

发起方
SB Istanbul Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erhan Aysan

MD Prof.

SB Istanbul Education and Research Hospital

研究点 (1)

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