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

AGIR à Dom

Status: Terminated

Conditions: Diabetic Foot; Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT01573897

12-AGIR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Foot-wound without SAS

Description:

patients with diabetic foot wound(or at risk of diabetic foot wound) without sleep apnea syndrome

Foot-wound with SAS

Description:

patients with diabetic foot wound(or at risk of diabetic foot wound) with sleep apnea syndrome