Impact of Sleep Apnea on Diabetic Foot Wound (SAS-FOOT)
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||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|
- Transcutaneous oxygen tension (PtcO2) [ Time Frame: 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
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573897
|Contact: Anne Laure Borel, MD-PhD||33476765509||ALborel@chu-grenoble.fr|
|Contact: Jean Christian Borel, PhDfirstname.lastname@example.org|
|Diabetes and Endocrinology Unit, Grenoble University Hospital||Recruiting|
|Grenoble, France, 38043|
|Principal Investigator:||Anne Laure Borel, MD-PhD||Diabetes and Endocrinology Unit, Grenoble University Hospital|