Diabetic FootSAS-FOOTNCT01573897
Impact of Sleep Apnea on Diabetic Foot Wound.
An observational study of Diabetic Foot and Sleep Apnea, run by AGIR à Dom at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Sleep Apnea
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2012to 15 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound
Who may be able to join
- 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
Who cannot join
- Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
- Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease
Trial locations and contacts
1 site in 1 country.
France1 site
Diabetes and Endocrinology Unit, Grenoble University Hospital
Grenoble, 38043
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Foot, Sleep Apnea
- Keywords
- Diabetes, Sleep apnea, Diabetic foot, Microcirculation
- Medical subject headings
- Diabetic Foot, Sleep Apnea Syndromes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Transcutaneous oxygen tension is assessed at the end of the night (5:00a.m) and at midday (12:00 a.m)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study start4 Jun 2012
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Why it stopped: Difficulty including subjects corresponding to the criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Borel, Pr MD PhD, Principal investigator, Diabetes and Endocrinology Unit, Grenoble University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573897
- Sponsor's protocol ID
- 12-AGIR-01
- Acronym
- SAS-FOOT
- Status last verified
- Jun 2018
- First submitted
- 6 Apr 2012
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01573897
- Acronym / sponsor ID
- SAS-FOOT / 12-AGIR-01
- Conditions
- Diabetic Foot, Sleep Apnea
- Keywords
- Diabetes, Sleep apnea, Diabetic foot, Microcirculation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty including subjects corresponding to the criteria.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- 4 Jun 2012 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutives diabetic patients referred to our tertiary diabetes unit (Grenoble University Hopsital, France) for diabetic foot wound
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with sleep apnea syndrome previously treated by positive airway pressure therapy.
- Patients previously treated by additional oxygen therapy. Patient with unstable psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Difficulty including subjects corresponding to the criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Laure Borel, Pr MD PhD principal investigator
Diabetes and Endocrinology Unit, Grenoble University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Sleep Apnea, run by AGIR à Dom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty including subjects corresponding to the criteria.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.