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Impact of Sleep Apnea on Diabetic Foot Wound. (SAS-FOOT)

2018年6月27日更新者：AGIR à Dom

Influence of Sleep Apnea Syndrome and Its Treatment by Positive Airway Pressure Therapy on Transcutaneous Oxygen Tension (PtcO2) in Patients With Foot Wound or at Risk for Foot Wound

Sleep apnea syndrome (SAS) is a common comorbidity of type 1 and type 2 diabetes. A low transcutaneous oxygen tension (PtcO2) measured on the foot is pejorative prognostic factor for the healing of a diabetic foot wound. SAS causes intermittent nocturnal hypoxia and sympathetic overactivity. The investigators hypothesized that SAS could be a factor reducing the PtcO2.Therefore, the main objective of this study is to assess the variation in PtcO2 between the end of the night and midday in patients with -or at risk of- diabetic foot wound according to the presence or not of sleep apnea syndrome.The secondary objective is to address the microvascularisation of diabetic patients having foot wounds according to their status regarding sleep apnea syndrome.

研究概览

地位

终止

条件

详细说明

The study is observational, cross-sectional. Presence of sleep apnea syndrome will be assessed on the same night than the main outcome, that is the difference in PtcO2 between 5:00 AM and 12:00AM. Microvascularisation will be assessed by Laser Speckle Contrast Imaging Analysis (LASCA).

Sample size is estimated at 60 patients based on previous revascularisation studies having PtcO2 as main outcome.

An intermediary analysis is planned after 40 inclusions.

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Grenoble、法国、38043
    - Diabetes and Endocrinology Unit, Grenoble University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound

描述

Inclusion Criteria:

Types 1 or 2 or MODY diabetes with diabetic foot wound (or at risk of foot wound stage 2 and 3 (see reference PMID:18442189).
Patients covered by social insurance

Exclusion Criteria:

Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Foot-wound without SAS patients with diabetic foot wound(or at risk of diabetic foot wound) without sleep apnea syndrome
Foot-wound with SAS patients with diabetic foot wound(or at risk of diabetic foot wound) with sleep apnea syndrome

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Transcutaneous oxygen tension (PtcO2) 大体时间：Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)	Transcutaneous oxygen tension (PtcO2)is measured with a Radiometer TCM4 (Radiometer, Copenhagen, Denmark) device, on the dorsum of the foot at the base of the second metatarsal, or as close to this location as possible. Calibration is performed before each measurement. All measurements are performed in supine position after 20 min of rest. Room temperature is kept constant (around 21°C-24°C). Patients are asked to avoid smoking or drinking coffee for at least 2 h before investigations	Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AGIR à Dom

调查人员

首席研究员：Anne-Laure Borel, Pr MD PhD、Diabetes and Endocrinology Unit, Grenoble University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年6月4日

初级完成 (实际的)

2016年11月15日

研究完成 (实际的)

2016年11月15日

研究注册日期

首次提交

2012年4月6日

首先提交符合 QC 标准的

2012年4月9日

首次发布 (估计)

2012年4月10日

研究记录更新

最后更新发布 (实际的)

2018年6月28日

上次提交的符合 QC 标准的更新

2018年6月27日

最后验证

2018年6月1日