Impact of Sleep Apnea on Diabetic Foot Wound.

NCT01573897 | Terminated

• 1 other identifier: 12-AGIR-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Sleep Apnea

Keywords

Diabetes; Sleep apnea; Diabetic foot; Microcirculation

Outcome Measures

Primary Outcomes (1)

• Transcutaneous oxygen tension (PtcO2)

  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

  Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound

You may qualify if:

• 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

You may not qualify if:

• Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
• Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (1)

Diabetes and Endocrinology Unit, Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetic Foot; Sleep Apnea Syndromes; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anne-Laure Borel, Pr MD PhD

  Diabetes and Endocrinology Unit, Grenoble University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: June 4, 2012
• Primary Completion: November 15, 2016
• Study Completion: November 15, 2016
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

FR (1)