Hypertensive Leg UlcerPhase 4ANGIOCATHNCT01964911
To Assess Analgesia Provided by Continuous Sciatic Nerve Block in Patients With Hypertensive Leg Ulcer
A Phase 4 study testing Ropivacaïne in people with Hypertensive Leg Ulcer, run by Nantes University Hospital at 1 site in France.
Trial summary
Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertensive Leg Ulcer
- What is being tested?
- Ropivacaïne
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to 13 Jul 2018
- Phase
- Phase 4
- 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
- Age >18 years old
- Hospitalized for hypertensive leg ulcer with severe pain :
- For which pain intensity has been collected over the first 3 days before catheter insertion (D0)
- With severe pain (mean or at wound care) in spite of acetaminophen treatment (NRS ≥ 5/10), and/or with adverse events related to weak or strong opioids.
- patients' written informed consent obtained
Who cannot join
- Patients with moderate pain after 3 days of usual pain management in hospitalization : mean NRS<5/10 the 24 hours before D0
- pregnant women
- other ulcer causes, local or systemic infection
- not able to provide informed consent or to answer the pain evaluation
- dialysis patients
- unstable active diseases
Show all 13Show fewer
- Charcot foot
- Known allergy to any local anesthetics
- Ankle-brachial index <0,6
- hemodynamically significant stenosis on arterial Doppler ultrasound
- current clopidogrel or prazugrel treatment the 10 days preceding catheter insertion
- current clopidogrel or prazugrel treatment the 10 days preceding catheter insertion, with contraindication to salicylic acid
- current anticoagulant treatment, with contraindication to LMWHs or UFH
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.
Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia.
This is why pain management is one of the main challenge in treatments of these ulcers.
Read more
Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation.
The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization.
Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days.
Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment.
The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne.
Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.
- Conditions
- Hypertensive Leg Ulcer
- Being tested
- Ropivacaïne
- Keywords
- Martorell ulcer, Hypertensive leg ulcer, Pain, Continuous nerve block, Ropivacaïne, Local anesthesic
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaïneDrug
The first 3 days, analgesic treatments will be provided, as usual, depending on pain intensity (EN <3/10 : non opioids, EN 3-5/10 : weak opioids, EN>5/10 : strong opioids).
If NRS is still over 5/10, continuous nerve block will be proposed. Patients will receive ropivacaïne, 5 mL/h during 7 days, with possibility of one bolus before wound care, through a stimulating catheter stimulong sono®.
In association, analgesic treatments will be provided, as usual, depending on pain intensity (as during the first 3 days).
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaïne | Experimental | Not described Receives: Drug: Ropivacaïne |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with a 50% decrease of one of the pain NRS
The main evaluation criteria will be at least a 50% decrease of one of the pain NRS (at rest, during wound care, maximal or mean) with 3 days of ropivacaïne treatment, compared to 3 days of usual analgesic treatment.
Measured: 3 days
Secondary outcomes (5)
Evolution of NRS
NRS during the 7 days of ropivacaïne, and during the 6 months follow up
Measured: 6 month
To assess patients's satisfaction with Patient Global Impression of Change
Measured: 6 month
To assess quality of life using Short Form 36 (SF36)
Quality of life using a standardized questionnaire : SF36
Measured: 6 month
To assess pain consequences using Hospital Anxiety and Depression Scale (HAD) and Brief Pain Inventory questionnaire(BPI)
Pain consequences using standardized questionnaire : HAD, BPI
Measured: 6 month
To assess microcirculatory evolution with a TCPO2 measure
Microcirculatory evolution with a TCPO2 measure before and after ropivacaïne treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile DURANT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964911
- Sponsor's protocol ID
- RC13_0252
- Acronym
- ANGIOCATH
- Status last verified
- Mar 2019
- First submitted
- 15 Oct 2013
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Prospective Study, in Order to Assess Analgesia Provided by Continuous Sciatic Nerve Block, in Patients With Hypertensive Leg Ulcer.
- ClinicalTrials.gov ID
- NCT01964911
- Acronym / sponsor ID
- ANGIOCATH / RC13_0252
- Conditions
- Hypertensive Leg Ulcer
- Keywords
- Martorell ulcer, Hypertensive leg ulcer, Pain, Continuous nerve block, Ropivacaïne, Local anesthesic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 17 Oct 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.
Hypertensive leg ulcer, also called Martorell ulcer, represents 1 to 15% of leg ulcers in hospital. These ulcers are painful, long to heal, and hospitalization is sometimes necessary for analgesia and debridement of necrotic tissue. Strong opioids are often required, and are responsible of many side effects. Martorell ulcer arises predominantly in women over 60 years of age, with history of vascular disease, and therefore with a higher risk of adverse event. Pain is also part of the physiopathology, inducing a vasospasm which increases ulcer extension and ischemia.
This is why pain management is one of the main challenge in treatments of these ulcers.
Continuous nerve block of lower limbs are often used during per and postoperative orthopaedic surgery. Few adverse events and rare serious adverse events related to local anesthesic are reported (respectively <1% and <1/1000), and few adverse events related to catheter are reported (<1%). Its benefits have been proved on post-operative pain management and reeducation.
The aim of this study is to assess analgesia provided by continuous sciatic nerve block, in patients with hypertensive leg ulcer, during hospitalization.
Thirty patients will be enrolled on a 3-years period. They will receive a continuous sciatic nerve block with ropivacaïne 0,2%, during 7 days.
Pain intensity will be assessed by 4 datas : numerating rating scale (NRS) at rest, during wound care, maximal and mean. These datas will be collected over two 3-days period : the first 3 days of hospitalization, in which pain treatment will be prescribed depending on pain intensity of the patient ; and the first 3 days of ropivacaïne treatment.
The main evaluation criteria will be at least a 50% decrease of one of the pain NRS when receiving ropivacaïne.
Time to healing, microcirculation evolution measured by Transcutaneous Oxygen Pressure (TcPO2), and quality of life of patients will be collected over a 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ropivacaïne | Experimental | Drug: Ropivacaïne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years old
- Hospitalized for hypertensive leg ulcer with severe pain :
- For which pain intensity has been collected over the first 3 days before catheter insertion (D0)
- With severe pain (mean or at wound care) in spite of acetaminophen treatment (NRS ≥ 5/10), and/or with adverse events related to weak or strong opioids.
- patients' written informed consent obtained
Key exclusion criteria (13 listed)
- Patients with moderate pain after 3 days of usual pain management in hospitalization : mean NRS<5/10 the 24 hours before D0
- pregnant women
- other ulcer causes, local or systemic infection
- not able to provide informed consent or to answer the pain evaluation
- dialysis patients
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 |
|---|---|---|
| RopivacaïneThe first 3 days, analgesic treatments will be provided, as usual, depending on pain intensity (EN <3/10 : non opioids, EN 3-5/10 : weak opioids, EN>5/10 : strong opioids). If NRS is still over 5/10, continuous nerve block will be proposed. Patients will receive ropivacaïne, 5 mL/h during 7 days, with possibility of one bolus before wound care, through a stimulating catheter stimulong sono®. In association, analgesic treatments will be provided, as usual, depending on pain intensity (as during the first 3 days). | Drug | Ropivacaïne |
Primary outcome
number of patient with a 50% decrease of one of the pain NRS
Time frame: 3 days
The main evaluation criteria will be at least a 50% decrease of one of the pain NRS (at rest, during wound care, maximal or mean) with 3 days of ropivacaïne treatment, compared to 3 days of usual analgesic treatment.
5 secondary outcomes
Evolution of NRS
Time frame: 6 month
To assess patients's satisfaction with Patient Global Impression of Change
Time frame: 6 month
To assess quality of life using Short Form 36 (SF36)
Time frame: 6 month
To assess pain consequences using Hospital Anxiety and Depression Scale (HAD) and Brief Pain Inventory questionnaire(BPI)
Time frame: 6 month
To assess microcirculatory evolution with a TCPO2 measure
Time frame: 6 month
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 2019.
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.
Cécile DURANT, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaïne in people with Hypertensive Leg Ulcer, run by Nantes University Hospital 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 5 inclusion and 13 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 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of patient with a 50% decrease of one of the pain NRS (time frame: 3 days). 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 5 Mar 2019.