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

This study is currently recruiting participants.

Verified May 2012 by AGIR à Dom

Sponsor:

Information provided by (Responsible Party):

AGIR à Dom

ClinicalTrials.gov Identifier:

NCT01573897

First received: April 6, 2012

Last updated: May 2, 2012

Last verified: May 2012

History of Changes

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 assess the impact of positive airway pressure therapy on PtcO2 measured at the end of the night.

Condition	Intervention
Diabetic Foot Sleep Apnea	Device: Positive airway pressure therapy

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
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:

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health Oxygen Therapy Sleep Apnea

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Device: Positive airway pressure therapy Patients with diabetic foot wound and sleep apnea syndrome are treated by positive airway pressure therapy for 2 consecutive nights versus sham-pressure therapy in a cross-over design (2nights of wash-out between effective therapy and placebo) Other Name: positive airway pressure therapy

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

No publications provided

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:	May 2, 2012
Health Authority:	France: Committee for the Protection of Personnes

Keywords provided by AGIR à Dom:

Diabetes
Sleep apnea
Diabetic foot
Positive Airway Pressure therapy

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 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 May 22, 2013

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