- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573897
Impact of Sleep Apnea on Diabetic Foot Wound. (SAS-FOOT)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Grenoble, France, 38043
- Diabetes and Endocrinology Unit, Grenoble University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Foot-wound without SAS
patients with diabetic foot wound(or at risk of diabetic foot wound) without sleep apnea syndrome
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Foot-wound with SAS
patients with diabetic foot wound(or at risk of diabetic foot wound) with sleep apnea syndrome
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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
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Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Laure Borel, Pr MD PhD, Diabetes and Endocrinology Unit, Grenoble University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Signs and Symptoms, Respiratory
- Foot Ulcer
- Sleep Apnea Syndromes
- Diabetic Foot
- Apnea
Other Study ID Numbers
- 12-AGIR-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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