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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by AGIR à Dom
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01573897
First received: April 6, 2012
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
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
Diabetic Foot
Sleep Apnea

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT01573897     History of Changes
Other Study ID Numbers: 12-AGIR-01 
Study First Received: April 6, 2012
Last Updated: January 7, 2016
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on December 09, 2016