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

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ClinicalTrials.gov Identifier: NCT01573897
Recruitment Status : Recruiting
First Posted : April 10, 2012
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom

Brief 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.

Condition or disease
Diabetic Foot Sleep Apnea

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 : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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 Start Date : May 2012
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Foot-wound without SAS
patients with diabetic foot wound(or at risk of diabetic foot wound) without sleep apnea syndrome
Foot-wound with SAS
patients with diabetic foot wound(or at risk of diabetic foot wound) with sleep apnea syndrome



Primary Outcome Measures :
  1. 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) ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573897


Contacts
Contact: Anne Laure Borel, MD-PhD 33476765509 ALborel@chu-grenoble.fr
Contact: Jean Christian Borel, PhD 33476510304 j.borel@agiradom.com

Locations
France
Diabetes and Endocrinology Unit, Grenoble University Hospital Recruiting
Grenoble, France, 38043
Sponsors and Collaborators
AGIR à Dom
Investigators
Principal Investigator: Anne Laure Borel, MD-PhD Diabetes and Endocrinology Unit, Grenoble University Hospital

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01573897     History of Changes
Other Study ID Numbers: 12-AGIR-01
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by AGIR à Dom:
Diabetes
Sleep apnea
Diabetic foot
microcirculation

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies