Impact of Sleep Apnea on Diabetic Foot Wound.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-04

Study Completion Date

2016-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Prevalence and Implications of Obstructive Sleep Apnea in the Population of a Wound Center

NCT00679757

Obstructive Sleep Apnea Non-healing Wounds

COMPLETED

CPAP Effect on Vascular Function in Obstructive Sleep Apnea

NCT02623088

Obstructive Sleep Apnea

COMPLETED

Sleep Disordered Breathing and Diabetes

NCT00901472

Type 2 Diabetes Obstructive Sleep Apnea

COMPLETED

Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

NCT01629862

Sleep Apnea, Obstructive Diabetes Mellitus

COMPLETED PHASE2

Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

NCT05462834

Sleep-Disordered Breathing Glucose Intolerance

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Foot-wound without SAS

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

No interventions assigned to this group

Foot-wound with SAS

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No