An observational study in Diabetic Foot and Sleep Apnea, sponsored by AGIR à Dom. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by AGIR à Dom · Observational
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 35 is below the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →AGIR à Dom is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound
Exclusion Criteria:
patients with diabetic foot wound(or at risk of diabetic foot wound) without sleep apnea syndrome
patients with diabetic foot wound(or at risk of diabetic foot wound) with sleep apnea syndrome
Transcutaneous oxygen tension (PtcO2)
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
Time frame: Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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AGIR à Dom