DiabetesNCT01804478
Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg
A study testing Mild pneumatic compression in people with Diabetes and Healthy, run by University of California, San Diego at 1 site in United States.
Trial summary
SPECIFIC AIMS The limbs of diabetic patients are associated with decreases in capillary density, arterial inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing and viability of tissue, especially in patients with peripheral vascular disease and diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Mild pneumatic compression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Feb 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- As long as there is no exclusion criteria
Who cannot join
- History of lower extremity vascular diseases such as atherosclerosis, intermittent claudication, acute or chronic deep venous thrombosis, presence of ankle edema, stasis dermatitis, active lower extremity ulcers or wounds, diabetic foot ulcers, diabetic neuropathy, history of lower extremity surgery.
- Pregnant women.
- Patients with abnormally large or misshapen legs.
- Patients with existing ulcers.
- Patients with poor underlying health.
- Patients with allergies to the study materials.
Show all 9Show fewer
- Patients who recently developed deep venous thrombosis (6 months)
- Patients with congenital A/V malformations.
- Patients with paraplegia.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92103
About this study
SPECIFIC AIMS
The limbs of diabetic patients are associated with decreases in capillary density, arterial inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing and viability of tissue, especially in patients with peripheral vascular disease and diabetes. The investigators hypothesize that mild external compression can restore the decreases in skin and muscle blood flow and that there would be greater increases in microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow will be measured using Photoplethysmography (PPG) before, during, and after external compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS).
Read more
The specific aims are:
- To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF) microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
- To measure muscle oxygenation changes in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
- To optimize pressures of Continuous Compression to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
- To optimize compression pressures, duration, and frequency of Intermittent Pneumatic Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
- To measure microcirculatory response to compression in patients with diabetes
- Continue to validate of photoplethysmography as a tool for measuring microcirculation.
Read the detailed description
BACKGROUND AND SIGNIFICANCE
Therapies utilizing external compression of the leg prevent deep venous thrombosis, decrease lower extremity edema, manage chronic venous insufficiency, and increase healing in the treatment of venous stasis ulcers. In diabetic patients' feet, microcirculation is compromised leading to increased chances of ulcer formation. Therefore, therapies utilizing compression of the lower leg could be beneficial to this population as compression therapies have shown to increase limb perfusion. In recent decades, investigators have found that intermittent compression of the calf or foot can produce acute increases in arterial inflow to a limb. Moreover, intermittent pneumatic compression at high pressures (120 mmHg) increases skin perfusion and popliteal artery inflow. Compression stockings produce much lower pressures (around 20-40 mmHg) but still aid in ulcer healing. The commercial systems have used rapid compression lasting for 3 s or less, with foot and calf pressures (80-100 mmHg). Longer compression durations (10 s at 60 mmHg) with moderate inflation rates in supine patients are effective in increasing flow velocity in the femoral artery, which means that systems do not necessarily need high levels of compression and rapid inflation periods that can be uncomfortable. An optimal therapy for individual patients with peripheral vascular disease should increase microvascular flow in the limb for the longest period possible.
Relatively little is known about local circulation in the context of treatment of venous disease with compression therapies. It is known that venous disease decreases muscle and skin oxygenation, and that there are acute and chronic physiologic adaptations to compression therapies such as increases in large and small vessel blood flow and capillary growth. Compression pressures ranging from 20-120 mmHg are used, but there is little physiologic evidence to support an optimal pressure for therapy. Little previous research has looked at the duration of hyperemia during external compression, but for the purpose of therapy it is important, since a compression cycle must set to maximize periods of hyperemia. Another unknown is whether intermittent compression increases blood flow to a greater extent compared to continuous compression. The major variables in compression therapies are compression pressure, duration of compression, and the frequency of compression. The investigators are not aware of any studies to date that have examined these variables in the context of skin and muscle microvascular blood flow in the leg.
Photoplethysmography (PPG) is a non-invasive optical technique that measures local microvascular blood flow. PPG directs light from a light emitting diode (LED) toward the skin; light is scattered and absorbed by the skin and deeper tissues. Green light LEDs are placed close to the photodetector to measure skin blood flow. Infrared LEDs are placed farther from the photodetector and penetrate up to several centimeters into underlying muscle. Blood flow changes in the tissue cause changes in the intensity of scattered light recorded by the photodetector. This technique has been validated in multiple studies against invasive methods and is considered to be the best non-invasive measurement of local muscle blood flow. For skeletal muscle, PPG provides equivalent results when compared with the invasive laser Doppler technique. However, frequent motion artifacts and local tissue trauma limit laser Doppler's usefulness. In patients with central venous hypertension due to heart failure, it is hypothesized that increases in compression-induced leg muscle microvascular blood flow will occur in proportion to increases in central venous pressure. It is also hypothesized that in patients with diabetes, increases in compression-induced foot microvascular blood flow will occur in proportion to increases in central venous pressure.
- Being tested
- Mild pneumatic compression
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild pneumatic compressionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Compression | Experimental | Both diabetic and control subjects will undergo mild pneumatic compression while tissue oxygenation and blood flow are recorded with a non-invasive NIRS and PPG device Receives: Behavioral: Mild pneumatic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Blood Flow
To measure muscle blood flow microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
Measured: 12 months
Secondary outcomes (1)
Skin Blood Flow
To measure skin blood flow microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMay 2005
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armando Rosales, MD, University of California, San Diego
- Investigators
- Alan R Hargens, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804478
- Sponsor's protocol ID
- 091793
- Status last verified
- Mar 2013
- First submitted
- 25 Feb 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Morris RJ, Woodcock JP. Evidence-based compression: prevention of stasis and deep vein thrombosis. Ann Surg. 2004 Feb;239(2):162-71. doi: 10.1097/01.sla.0000109149.77194.6c.
PubMed 14745323Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, Comerota AJ Jr. Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg. 1996 Aug;172(2):130-4; discussion 135. doi: 10.1016/S0002-9610(96)00134-1.
PubMed 8795514Eze AR, Cisek PL, Holland BS, Comerota AJ Jr, Verramasuneni R, Comerota AJ. The contributions of arterial and venous volumes to increased cutaneous blood flow during leg compression. Ann Vasc Surg. 1998 Mar;12(2):182-6. doi: 10.1007/s100169900138.
PubMed 9514239van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8. doi: 10.1016/s0741-5214(94)70217-9.
PubMed 8201706Trent JT, Falabella A, Eaglstein WH, Kirsner RS. Venous ulcers: pathophysiology and treatment options. Ostomy Wound Manage. 2005 May;51(5):38-54; quiz 55-6.
PubMed 16014984Abu-Own A, Cheatle T, Scurr JH, Coleridge Smith PD. Effects of intermittent pneumatic compression of the foot on the microcirculatory function in arterial disease. Eur J Vasc Surg. 1993 Sep;7(5):488-92. doi: 10.1016/s0950-821x(05)80358-5.
PubMed 8405490Delis KT, Labropoulos N, Nicolaides AN, Glenville B, Stansby G. Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):270-7. doi: 10.1053/ejvs.1999.1028.
PubMed 10753690Morris RJ, Woodcock JP. Effects of supine intermittent compression on arterial inflow to the lower limb. Arch Surg. 2002 Nov;137(11):1269-73. doi: 10.1001/archsurg.137.11.1269.
PubMed 12413316Agu O, Baker D, Seifalian AM. Effect of graduated compression stockings on limb oxygenation and venous function during exercise in patients with venous insufficiency. Vascular. 2004 Jan;12(1):69-76. doi: 10.1258/rsmvasc.12.1.69.
PubMed 15127858Junger M, Steins A, Hahn M, Hafner HM. Microcirculatory dysfunction in chronic venous insufficiency (CVI). Microcirculation. 2000;7(6 Pt 2):S3-12.
PubMed 11151969Morris RJ, Woodcock JP. Intermittent venous compression, and the duration of hyperaemia in the common femoral artery. Clin Physiol Funct Imaging. 2004 Jul;24(4):237-42. doi: 10.1111/j.1475-097X.2004.00556.x.
PubMed 15233839Sandberg M, Zhang Q, Styf J, Gerdle B, Lindberg LG. Non-invasive monitoring of muscle blood perfusion by photoplethysmography: evaluation of a new application. Acta Physiol Scand. 2005 Apr;183(4):335-43. doi: 10.1111/j.1365-201X.2005.01412.x.
PubMed 15799770Zhang Q, Lindberg LG, Kadefors R, Styf J. A non-invasive measure of changes in blood flow in the human anterior tibial muscle. Eur J Appl Physiol. 2001 May;84(5):448-52. doi: 10.1007/s004210100413.
PubMed 11417434Hanna GB, Newton DJ, Harrison DK, Belch JJ, McCollum PT. Use of lightguide spectrophotometry to quantify skin oxygenation in a variable model of venous hypertension. Br J Surg. 1995 Oct;82(10):1352-6. doi: 10.1002/bjs.1800821018.
PubMed 7489162Zhang Q, Styf J, Lindberg LG. Effects of limb elevation and increased intramuscular pressure on human tibialis anterior muscle blood flow. Eur J Appl Physiol. 2001 Oct;85(6):567-71. doi: 10.1007/s004210100496.
PubMed 11718286
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Microvascular Blood Flow During Mild External Compression of the Leg
- ClinicalTrials.gov ID
- NCT01804478
- Acronym / sponsor ID
- 091793
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Mar 2013 (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.
SPECIFIC AIMS
The limbs of diabetic patients are associated with decreases in capillary density, arterial inflow, and local blood flow of the leg. Decreased perfusion adversely affects wound healing and viability of tissue, especially in patients with peripheral vascular disease and diabetes. The investigators hypothesize that mild external compression can restore the decreases in skin and muscle blood flow and that there would be greater increases in microvascular blood flow induced by leg compression compared to healthy subjects. Blood flow will be measured using Photoplethysmography (PPG) before, during, and after external compression, and muscle oxygenation will be measured with Near Infrared Spectroscopy (NIRS).
The specific aims are:
- To measure Muscle Blood Flow (MBF), Skin Blood Flow (SBF), and Bone Blood Flow (BBF) microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
- To measure muscle oxygenation changes in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
- To optimize pressures of Continuous Compression to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
- To optimize compression pressures, duration, and frequency of Intermittent Pneumatic Compression (IPC) to induce maximum microcirculatory blood flow in healthy subjects and patients with diabetes.
- To measure microcirculatory response to compression in patients with diabetes
- Continue to validate of photoplethysmography as a tool for measuring microcirculation.
Detailed description
BACKGROUND AND SIGNIFICANCE
Therapies utilizing external compression of the leg prevent deep venous thrombosis, decrease lower extremity edema, manage chronic venous insufficiency, and increase healing in the treatment of venous stasis ulcers. In diabetic patients' feet, microcirculation is compromised leading to increased chances of ulcer formation. Therefore, therapies utilizing compression of the lower leg could be beneficial to this population as compression therapies have shown to increase limb perfusion. In recent decades, investigators have found that intermittent compression of the calf or foot can produce acute increases in arterial inflow to a limb. Moreover, intermittent pneumatic compression at high pressures (120 mmHg) increases skin perfusion and popliteal artery inflow. Compression stockings produce much lower pressures (around 20-40 mmHg) but still aid in ulcer healing. The commercial systems have used rapid compression lasting for 3 s or less, with foot and calf pressures (80-100 mmHg). Longer compression durations (10 s at 60 mmHg) with moderate inflation rates in supine patients are effective in increasing flow velocity in the femoral artery, which means that systems do not necessarily need high levels of compression and rapid inflation periods that can be uncomfortable. An optimal therapy for individual patients with peripheral vascular disease should increase microvascular flow in the limb for the longest period possible.
Relatively little is known about local circulation in the context of treatment of venous disease with compression therapies. It is known that venous disease decreases muscle and skin oxygenation, and that there are acute and chronic physiologic adaptations to compression therapies such as increases in large and small vessel blood flow and capillary growth. Compression pressures ranging from 20-120 mmHg are used, but there is little physiologic evidence to support an optimal pressure for therapy. Little previous research has looked at the duration of hyperemia during external compression, but for the purpose of therapy it is important, since a compression cycle must set to maximize periods of hyperemia. Another unknown is whether intermittent compression increases blood flow to a greater extent compared to continuous compression. The major variables in compression therapies are compression pressure, duration of compression, and the frequency of compression. The investigators are not aware of any studies to date that have examined these variables in the context of skin and muscle microvascular blood flow in the leg.
Photoplethysmography (PPG) is a non-invasive optical technique that measures local microvascular blood flow. PPG directs light from a light emitting diode (LED) toward the skin; light is scattered and absorbed by the skin and deeper tissues. Green light LEDs are placed close to the photodetector to measure skin blood flow. Infrared LEDs are placed farther from the photodetector and penetrate up to several centimeters into underlying muscle. Blood flow changes in the tissue cause changes in the intensity of scattered light recorded by the photodetector. This technique has been validated in multiple studies against invasive methods and is considered to be the best non-invasive measurement of local muscle blood flow. For skeletal muscle, PPG provides equivalent results when compared with the invasive laser Doppler technique. However, frequent motion artifacts and local tissue trauma limit laser Doppler's usefulness. In patients with central venous hypertension due to heart failure, it is hypothesized that increases in compression-induced leg muscle microvascular blood flow will occur in proportion to increases in central venous pressure. It is also hypothesized that in patients with diabetes, increases in compression-induced foot microvascular blood flow will occur in proportion to increases in central venous pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Compression | Experimental | Behavioral: Mild pneumatic compressionBoth diabetic and control subjects will undergo mild pneumatic compression while tissue oxygenation and blood flow are recorded with a non-invasive NIRS and PPG device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- As long as there is no exclusion criteria
Key exclusion criteria (9 listed)
- History of lower extremity vascular diseases such as atherosclerosis, intermittent claudication, acute or chronic deep venous thrombosis, presence of ankle edema, stasis dermatitis, active lower extremity ulcers or wounds, diabetic foot ulcers, diabetic neuropathy, history of lower extremity surgery.
- Pregnant women.
- Patients with abnormally large or misshapen legs.
- Patients with existing ulcers.
- Patients with poor underlying health.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mild pneumatic compression | Behavioural | Pneumatic Compression |
Primary outcome
Muscle Blood Flow
Time frame: 12 months
To measure muscle blood flow microcirculatory alterations in the leg and foot caused by mild external compression in healthy subjects and patients with diabetes.
1 secondary outcome
Skin Blood Flow
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Background: PubMed 14745323Morris RJ, Woodcock JP. Evidence-based compression: prevention of stasis and deep vein thrombosis. Ann Surg. 2004 Feb;239(2):162-71. doi: 10.1097/01.sla.0000109149.77194.6c.
- Background: PubMed 8795514Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R, Comerota AJ Jr. Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg. 1996 Aug;172(2):130-4; discussion 135. doi: 10.1016/S0002-9610(96)00134-1.
- Background: PubMed 9514239Eze AR, Cisek PL, Holland BS, Comerota AJ Jr, Verramasuneni R, Comerota AJ. The contributions of arterial and venous volumes to increased cutaneous blood flow during leg compression. Ann Vasc Surg. 1998 Mar;12(2):182-6. doi: 10.1007/s100169900138.
- Background: PubMed 8201706van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8. doi: 10.1016/s0741-5214(94)70217-9.
- Background: PubMed 16014984Trent JT, Falabella A, Eaglstein WH, Kirsner RS. Venous ulcers: pathophysiology and treatment options. Ostomy Wound Manage. 2005 May;51(5):38-54; quiz 55-6.
- Background: PubMed 8405490Abu-Own A, Cheatle T, Scurr JH, Coleridge Smith PD. Effects of intermittent pneumatic compression of the foot on the microcirculatory function in arterial disease. Eur J Vasc Surg. 1993 Sep;7(5):488-92. doi: 10.1016/s0950-821x(05)80358-5.
- Background: PubMed 10753690Delis KT, Labropoulos N, Nicolaides AN, Glenville B, Stansby G. Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. Eur J Vasc Endovasc Surg. 2000 Mar;19(3):270-7. doi: 10.1053/ejvs.1999.1028.
- Background: PubMed 12413316Morris RJ, Woodcock JP. Effects of supine intermittent compression on arterial inflow to the lower limb. Arch Surg. 2002 Nov;137(11):1269-73. doi: 10.1001/archsurg.137.11.1269.
- Background: PubMed 15127858Agu O, Baker D, Seifalian AM. Effect of graduated compression stockings on limb oxygenation and venous function during exercise in patients with venous insufficiency. Vascular. 2004 Jan;12(1):69-76. doi: 10.1258/rsmvasc.12.1.69.
- Background: PubMed 11151969Junger M, Steins A, Hahn M, Hafner HM. Microcirculatory dysfunction in chronic venous insufficiency (CVI). Microcirculation. 2000;7(6 Pt 2):S3-12.
- Background: PubMed 15233839Morris RJ, Woodcock JP. Intermittent venous compression, and the duration of hyperaemia in the common femoral artery. Clin Physiol Funct Imaging. 2004 Jul;24(4):237-42. doi: 10.1111/j.1475-097X.2004.00556.x.
- Background: PubMed 15799770Sandberg M, Zhang Q, Styf J, Gerdle B, Lindberg LG. Non-invasive monitoring of muscle blood perfusion by photoplethysmography: evaluation of a new application. Acta Physiol Scand. 2005 Apr;183(4):335-43. doi: 10.1111/j.1365-201X.2005.01412.x.
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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.
Alan R Hargens, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild pneumatic compression in people with Diabetes and Healthy, run by University of California, San Diego at 1 site in United States.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 5 Mar 2013. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Blood Flow (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804478, which also lists 23 linked publications.
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 5 Mar 2013.