NCT01573897

Impact of Sleep Apnea on Diabetic Foot Wound.

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: AGIR à Dom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Foot
• Sleep Apnea

Timeline

• Start date: 2012-06-04
• Primary completion: 2016-11-15
• Completion: 2016-11-15
• First posted: 2012-04-10
• Last updated: 2018-06-28

Locations

1 site across 1 country: France