Chronic Leg UlcerNCT02696460
Efficacy of 50% Nitrous Oxide/50% Oxygen Gas Premix in Chronic Leg Ulcer Debridement
A study testing N2O/O2 analgesia and Lidocaine/Prilocaine analgesia in people with Chronic Leg Ulcer, run by Venenklinik Bellevue.
Trial summary
Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leg Ulcer
- What is being tested?
- N2O/O2 analgesia and Lidocaine/Prilocaine analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of chronic leg ulcer persisting for more than six weeks despite initial conservative treatment; written informed consent
Who cannot join
- Other chronic wounds than leg ulcers
- Peripheral polyneuropathy
- Non-specified peripheral sensibility disorders
- Allergies or contraindications against the study agents
- Lack of informed consent
- Pregnancy or breast feeding
- Anticipated need for less than two surgical debridement
About this study
Official title: Efficacy of Inhaled 50% Equimolar Nitrous Oxide/Oxygen Gas Premix (Kalinox®) as Compared to Topically Administered 5% Eutectic Mixture of Lidocaine/Prilocaine (EMLA®) in Chronic Leg Ulcer Debridement
Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.
Read the detailed description
Study design: Prospective, controlled, single-center, cross-over design study. The study protocol was approved by the local ethical committee.
Study setting/participants: The study is performed in a highly specialized secondary care vein center. Patients with chronic foot and leg ulcer disease that are scheduled for repetitive ulcer debridement are eligible for the study and included into the study provided that written informed consent is obtained and no exclusion criteria are present.
Debridement procedure: For debridement, disposable sterile scalpel blades, ring curettes, and sterilized reusable scissors and forceps are used. The intended sharp mechanical debridement is proceeded as long as it is tolerated by the patient or terminated as planned. It will immediately be discontinued if the patient asks for it due to intolerable pain or discomfort.
Analgesia methods: For analgesia during debridement, either a topically administered eutectic mixture of 5% lidocaine/prilocaine (EMLA®) or an inhaled premix of 50% nitrous oxide/50% oxygen (Kalinox®) are used. The 5% lidocaine/prilocaine cream is administered as a thick layer directly onto the wound with a scoop and the wound is sealed with a polyurethane foil. After 30 minutes of exposure time, the foil is removed and debridement is started immediately. For analgesia with the inhaled 50% nitrous oxide/50% oxygen premix, the patient is asked to hold an inhalation rebreather mask with on-demand-valve tightly placed onto the face after being instructed on how to inhale the gas premix. After 3 minutes of exposure time to the gas premix, debridement is started immediately. Gas inhalation is sustained until final wound dressing is applied. During the entire procedure with each analgesia method, vital signs such as non-invasive blood pressure, heart rate and peripheral oxygen saturation (SpO2) are be recorded.
Allocation of the analgesia regimen: After study enrollment, patients are consecutively numbered starting at one. Even numbered patients have the first debridement done with topical administration of lidocaine/prilocaine cream, followed by inhaled nitrous oxide/oxygen premix for the second debridement, and again followed in an alternating way by both tested analgesia methods up to a maximum of 4 interventions. Uneven numbered patients receive inhaled nitrous oxide/oxygen premix first, followed by topical lidocaine/prilocaine cream. After 4 debridement in total with 2 sets of each analgesia method, the study period for each single patient will be secluded. A maximum of 4 data sets per patient will be brought to data analysis.
Outcome measures: Primary outcome is the change of pain perception from baseline (1 minute before debridement) to time point of maximum debridement/wound profoundness (up to 10 minutes after start of debridement) as measured by the visual analogue scale (VAS). Secondary outcomes are change of pain perception from time point of maximum debridement/wound profoundness to 5 minutes after debridement as measured by the visual analogue scale (VAS), duration of treatment session, duration of debridement, achievement of treatment goal (completion), subjective general perception of analgesia quality during debridement (patient comfort). Baseline characteristics are gender, age, ulcer etiology, time passed between initial ulcer diagnosis and first debridement, wound emergence in terms of suspected trigger for ulcer development, and wound size.
- Conditions
- Chronic Leg Ulcer
- Being tested
- N2O/O2 analgesia, Lidocaine/Prilocaine analgesia
- Keywords
- debridement, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N2O/O2 analgesiaProcedure or surgery
Also called Kalinox® analgesia
Analgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix.
Lidocaine/Prilocaine analgesiaProcedure or surgery
Also called EMLA® analgesia
Analgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream.
| Study group | Role | What they receive |
|---|---|---|
| N2O/O2 analgesia | Active comparator | Wound debridement under analgesia with N2O/O2 premix. Receives: Procedure: N2O/O2 analgesia; Procedure: Lidocaine/Prilocaine analgesia |
| Lidocaine/Prilocaine analgesia | Active comparator | Wound debridement under analgesia with eutectic mixture of 5% lidocaine/prilocaine. Receives: Procedure: N2O/O2 analgesia; Procedure: Lidocaine/Prilocaine analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain Level as Measured by Visual Analogue Scale (VAS)
Change of measured VAS between Time Point "Baseline", which is 1 Minute Before Start of Surgical Debridement, and Time Point "End of Surgical Debridement", which is at Maximum Wound Profoundness and up to 10 Minutes after Start of Surgical Debridement.
Measured: Change of VAS from Time Point "Baseline 1 Minute before Start of Surgical Debridement" at Time Point "End of Surgical Debridement up to 10 Minutes after Start of Surgical Debridement"
Secondary outcomes (5)
Change of Pain Level as Measured by Visual Analogue Scale (VAS)
Change of measured VAS between Time Point "End of Surgical Debridement", which is at Maximum Wound Profoundness during Debridement, and Time Point "5 Minutes after Surgical Debridement".
Measured: Change of VAS from Time Point "End of Surgical Debridement" at Time Point "5 Minutes After Surgical Debridement"
Overall Duration of Treatment Session
Time Patient Spent in Outpatient Clinic for Treatment Session
Measured: From Admission to Discharge up to 60 Minutes
Duration of Wound Debridement
Total Procedure Time of Debridement
Measured: From Start to End of Debridement up to 10 Minutes
Achievement of Treatment Goal
Surgeon's Judgement whether Debridement was Completed as Planned or Interrupted Prematurely due to Pain and/or Patient Discomfort.
Measured: From Start to End of Debridement up to 10 Minutes
Overall Analgesia Quality
Patient's Subjective Perception of Analgesia Quality within the Time Frame of Debridement.
Measured: From Start to End of Debridement up to 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Leg UlcerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venenklinik Bellevue
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juerg Traber, Venenklinik Bellevue
- Investigators
- Juerg Traber, MD, Principal investigator, Venenklinik Bellevue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696460
- Sponsor's protocol ID
- VB_01_2010
- Status last verified
- Feb 2016
- First submitted
- 8 Dec 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7. doi: 10.2165/00002512-200724060-00006.
PubMed 17571915Onody P, Gil P, Hennequin M. Safety of inhalation of a 50% nitrous oxide/oxygen premix: a prospective survey of 35 828 administrations. Drug Saf. 2006;29(7):633-40. doi: 10.2165/00002018-200629070-00008.
PubMed 16808555Zwakhalen SM, Hamers JP, Berger MP. Improving the clinical usefulness of a behavioural pain scale for older people with dementia. J Adv Nurs. 2007 Jun;58(5):493-502. doi: 10.1111/j.1365-2648.2007.04255.x. Epub 2007 Apr 17.
PubMed 17442027Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics. 2000 Apr;105(4):E47. doi: 10.1542/peds.105.4.e47.
PubMed 10742368Evans E, Gray M. Do topical analgesics reduce pain associated with wound dressing changes or debridement of chronic wounds? J Wound Ostomy Continence Nurs. 2005 Sep-Oct;32(5):287-90. doi: 10.1097/00152192-200509000-00002. No abstract available.
PubMed 16234718Hee HI, Goy RW, Ng AS. Effective reduction of anxiety and pain during venous cannulation in children: a comparison of analgesic efficacy conferred by nitrous oxide, EMLA and combination. Paediatr Anaesth. 2003 Mar;13(3):210-6. doi: 10.1046/j.1460-9592.2003.01051.x.
PubMed 12641682Doughty DB. Strategies for minimizing chronic wound pain. Adv Skin Wound Care. 2006 Mar;19(2):82-5. doi: 10.1097/00129334-200603000-00009. No abstract available.
PubMed 16557053Rosenthal D, Murphy F, Gottschalk R, Baxter M, Lycka B, Nevin K. Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. J Wound Care. 2001 Jan;10(1):503-5. doi: 10.12968/jowc.2001.10.1.26042.
PubMed 12964231Holm J, Andren B, Grafford K. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Acta Derm Venereol. 1990;70(2):132-6.
PubMed 1969197
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled 50% Equimolar Nitrous Oxide/Oxygen Gas Premix (Kalinox®) as Compared to Topically Administered 5% Eutectic Mixture of Lidocaine/Prilocaine (EMLA®) in Chronic Leg Ulcer Debridement
- ClinicalTrials.gov ID
- NCT02696460
- Acronym / sponsor ID
- VB_01_2010
- Conditions
- Chronic Leg Ulcer
- Keywords
- debridement, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Venenklinik BellevueUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Mar 2016 (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.
Adequate analgesia in serial chronic leg ulcer debridement can be difficult to achieve. A common analgesia method is the topical administration of local anesthetics directly onto the wound. However, complete wound debridement is often hampered by insufficient analgesia leading to interruption of the actual debridement and fragmentation of treatment into more frequent serial debridement sessions. Alternatively, the inhalation of an nitrous oxide/oxygen (N2O/O2) gas premix could be used for analgesia. In this study, the investigators have compared the analgesic method of an eutectic mixture of topically administered lidocaine/prilocaine cream (EMLA®) with the inhalation of an equimolar 50% N2O/50% O2 gas premix (Kalinox®) in serial leg ulcer debridement.
Detailed description
Study design: Prospective, controlled, single-center, cross-over design study. The study protocol was approved by the local ethical committee.
Study setting/participants: The study is performed in a highly specialized secondary care vein center. Patients with chronic foot and leg ulcer disease that are scheduled for repetitive ulcer debridement are eligible for the study and included into the study provided that written informed consent is obtained and no exclusion criteria are present.
Debridement procedure: For debridement, disposable sterile scalpel blades, ring curettes, and sterilized reusable scissors and forceps are used. The intended sharp mechanical debridement is proceeded as long as it is tolerated by the patient or terminated as planned. It will immediately be discontinued if the patient asks for it due to intolerable pain or discomfort.
Analgesia methods: For analgesia during debridement, either a topically administered eutectic mixture of 5% lidocaine/prilocaine (EMLA®) or an inhaled premix of 50% nitrous oxide/50% oxygen (Kalinox®) are used. The 5% lidocaine/prilocaine cream is administered as a thick layer directly onto the wound with a scoop and the wound is sealed with a polyurethane foil. After 30 minutes of exposure time, the foil is removed and debridement is started immediately. For analgesia with the inhaled 50% nitrous oxide/50% oxygen premix, the patient is asked to hold an inhalation rebreather mask with on-demand-valve tightly placed onto the face after being instructed on how to inhale the gas premix. After 3 minutes of exposure time to the gas premix, debridement is started immediately. Gas inhalation is sustained until final wound dressing is applied. During the entire procedure with each analgesia method, vital signs such as non-invasive blood pressure, heart rate and peripheral oxygen saturation (SpO2) are be recorded.
Allocation of the analgesia regimen: After study enrollment, patients are consecutively numbered starting at one. Even numbered patients have the first debridement done with topical administration of lidocaine/prilocaine cream, followed by inhaled nitrous oxide/oxygen premix for the second debridement, and again followed in an alternating way by both tested analgesia methods up to a maximum of 4 interventions. Uneven numbered patients receive inhaled nitrous oxide/oxygen premix first, followed by topical lidocaine/prilocaine cream. After 4 debridement in total with 2 sets of each analgesia method, the study period for each single patient will be secluded. A maximum of 4 data sets per patient will be brought to data analysis.
Outcome measures: Primary outcome is the change of pain perception from baseline (1 minute before debridement) to time point of maximum debridement/wound profoundness (up to 10 minutes after start of debridement) as measured by the visual analogue scale (VAS). Secondary outcomes are change of pain perception from time point of maximum debridement/wound profoundness to 5 minutes after debridement as measured by the visual analogue scale (VAS), duration of treatment session, duration of debridement, achievement of treatment goal (completion), subjective general perception of analgesia quality during debridement (patient comfort). Baseline characteristics are gender, age, ulcer etiology, time passed between initial ulcer diagnosis and first debridement, wound emergence in terms of suspected trigger for ulcer development, and wound size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N2O/O2 analgesia | Active comparator | Procedure: N2O/O2 analgesia, Procedure: Lidocaine/Prilocaine analgesiaWound debridement under analgesia with N2O/O2 premix. |
| Lidocaine/Prilocaine analgesia | Active comparator | Procedure: N2O/O2 analgesia, Procedure: Lidocaine/Prilocaine analgesiaWound debridement under analgesia with eutectic mixture of 5% lidocaine/prilocaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of chronic leg ulcer persisting for more than six weeks despite initial conservative treatment; written informed consent
Key exclusion criteria (7 listed)
- Other chronic wounds than leg ulcers
- Peripheral polyneuropathy
- Non-specified peripheral sensibility disorders
- Allergies or contraindications against the study agents
- Lack of informed consent
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 |
|---|---|---|
| N2O/O2 analgesiaAlso: Kalinox® analgesiaAnalgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix. | Procedure or surgery | Lidocaine/Prilocaine analgesia, N2O/O2 analgesia |
| Lidocaine/Prilocaine analgesiaAlso: EMLA® analgesiaAnalgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream. | Procedure or surgery | Lidocaine/Prilocaine analgesia, N2O/O2 analgesia |
Primary outcome
Change of Pain Level as Measured by Visual Analogue Scale (VAS)
Time frame: Change of VAS from Time Point "Baseline 1 Minute before Start of Surgical Debridement" at Time Point "End of Surgical Debridement up to 10 Minutes after Start of Surgical Debridement"
Change of measured VAS between Time Point "Baseline", which is 1 Minute Before Start of Surgical Debridement, and Time Point "End of Surgical Debridement", which is at Maximum Wound Profoundness and up to 10 Minutes after Start of Surgical Debridement.
5 secondary outcomes
Change of Pain Level as Measured by Visual Analogue Scale (VAS)
Time frame: Change of VAS from Time Point "End of Surgical Debridement" at Time Point "5 Minutes After Surgical Debridement"
Overall Duration of Treatment Session
Time frame: From Admission to Discharge up to 60 Minutes
Duration of Wound Debridement
Time frame: From Start to End of Debridement up to 10 Minutes
Achievement of Treatment Goal
Time frame: From Start to End of Debridement up to 10 Minutes
Overall Analgesia Quality
Time frame: From Start to End of Debridement up to 10 Minutes
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 2 Mar 2016.
- Background: PubMed 17571915Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7. doi: 10.2165/00002512-200724060-00006.
- Background: PubMed 16808555Onody P, Gil P, Hennequin M. Safety of inhalation of a 50% nitrous oxide/oxygen premix: a prospective survey of 35 828 administrations. Drug Saf. 2006;29(7):633-40. doi: 10.2165/00002018-200629070-00008.
- Background: PubMed 17442027Zwakhalen SM, Hamers JP, Berger MP. Improving the clinical usefulness of a behavioural pain scale for older people with dementia. J Adv Nurs. 2007 Jun;58(5):493-502. doi: 10.1111/j.1365-2648.2007.04255.x. Epub 2007 Apr 17.
- Background: PubMed 10742368Annequin D, Carbajal R, Chauvin P, Gall O, Tourniaire B, Murat I. Fixed 50% nitrous oxide oxygen mixture for painful procedures: A French survey. Pediatrics. 2000 Apr;105(4):E47. doi: 10.1542/peds.105.4.e47.
- Background: PubMed 16234718Evans E, Gray M. Do topical analgesics reduce pain associated with wound dressing changes or debridement of chronic wounds? J Wound Ostomy Continence Nurs. 2005 Sep-Oct;32(5):287-90. doi: 10.1097/00152192-200509000-00002. No abstract available.
- Background: PubMed 12641682Hee HI, Goy RW, Ng AS. Effective reduction of anxiety and pain during venous cannulation in children: a comparison of analgesic efficacy conferred by nitrous oxide, EMLA and combination. Paediatr Anaesth. 2003 Mar;13(3):210-6. doi: 10.1046/j.1460-9592.2003.01051.x.
- Background: PubMed 16557053Doughty DB. Strategies for minimizing chronic wound pain. Adv Skin Wound Care. 2006 Mar;19(2):82-5. doi: 10.1097/00129334-200603000-00009. No abstract available.
- Background: PubMed 12964231Rosenthal D, Murphy F, Gottschalk R, Baxter M, Lycka B, Nevin K. Using a topical anaesthetic cream to reduce pain during sharp debridement of chronic leg ulcers. J Wound Care. 2001 Jan;10(1):503-5. doi: 10.12968/jowc.2001.10.1.26042.
- Background: PubMed 1969197Holm J, Andren B, Grafford K. Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Acta Derm Venereol. 1990;70(2):132-6.
- Individual participant dataSharing planned: No
Related trials for Chronic Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
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.
Juerg Traber, MD principal investigator
Venenklinik Bellevue
Questions about this trial
What is this clinical trial studying?
A study testing N2O/O2 analgesia and Lidocaine/Prilocaine analgesia in people with Chronic Leg Ulcer, run by Venenklinik Bellevue.
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 7 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of Pain Level as Measured by Visual Analogue Scale (VAS) (time frame: Change of VAS from Time Point "Baseline 1 Minute before Start of Surgical Debridement" at Time Point "End of Surgical Debridement up to 10 Minutes after Start of Surgical Debridement"). 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 NCT02696460, which also lists 9 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 2 Mar 2016.