Diabetic Neuropathy PeripheralDIALOXYNCT03354806
Peripheral Analgesia in Painful Diabetic Neuropathy
A study testing Continuous peripheral nerve blocks and Analgesic treatment in people with Diabetic Neuropathy Peripheral and Neuropathic Pain, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that lead to chronic limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy Peripheral, Neuropathic Pain, Diabetic Foot Infection
- What is being tested?
- Continuous peripheral nerve blocks and Analgesic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Dec 2019
- 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
- Hospitalized patient
- Diabetics with chronic obliterative arteriopathy of the inferior limbs
- Permanent limb ischaemia with a TcPO2 of the front-foot of at least 10 mmHg under atmospheric conditions
- Lack of surgical revascularization
- No contraindication to hyperbaric therapy
- Signed informed consent
Who cannot join
- Contraindication to ropivacaine
- Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency)
- patients with planned limb amputation
About this study
Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that lead to chronic limb ischemia. Without possible surgical revascularization ,pain management and tissue healing are used to avoid amputation.
Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the inferior limbs, is also increases.
This study compares the efficiency of two analgesic treatments in diabetics with forefoot injuries.
Read the detailed description
Patients are allocated in two groups regarding :
- their eligibility to analgesic treatment using continuous peripheral nerve blocks
- the unability of usual pain management to reduce their pain (pain visual analogic scale equal to or more than 4).
When patient 's response to pharmacological analgesic treatment is sufficient (pain visual analogic scale equal to or less than 3), patient is allocated to the control group.
Patients of experimental group received a continous analgesic treatment for 6 weeks using ropivacaine (2mg/ml, flow rate 7 ml/h).
Patients of control group received an analgesic treatment according the recommended pain ladder of World Health Organization (WHO). Opioids for mild-to-moderate pain are used in combination with a non-opioid analgesic, such as paracetamol, at the second step of the ladder. If regular maximum doses of opioids for mild-to-moderate pain do not achieve adequate analgesia, then they should be replaced with an opioid for moderate-to-severe pain, such as morphine.
Efficiency of both treatment is assessed the improvement of oxygen level in the tissue below the skin of the injured forefoot through the study.
- Being tested
- Continuous peripheral nerve blocks, Analgesic treatment
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous peripheral nerve blocksProcedure or surgery
6 weeks-ropivacaine treatment delivered by continuous peripheral nerve blocks Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions
Analgesic treatmentProcedure or surgery
6 weeks-analgesic treatment according to WHO's pain relief ladder Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions
| Study group | Role | What they receive |
|---|---|---|
| Continuous peripheral nerve blocks | Experimental | Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks Receives: Procedure: Continuous peripheral nerve blocks |
| Analgesic treatment | Active comparator | Pharmacological pain management in accordance with WHO's pain relief ladder Receives: Procedure: Analgesic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot tissue oxygenation on day 2
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Measured: on day 2
Secondary outcomes (3)
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Measured: on day 2
Foot tissue oxygenation on week 6
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Measured: on week 6
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Measured: on week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startJun 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: january 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, monocentric study including 2 parallel groups. Patient's allocation is based on recommended criteria for catheters for continuous peripheral nerve blocks uses such as anlagesic treatment (ropivacain) tolerance and acceptance or analgesic treatment refusal
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie NAKAMURA, MD, Principal investigator, Centre Hpospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354806
- Sponsor's protocol ID
- 2016/CHU/05
- Acronym
- DIALOXY
- Status last verified
- Mar 2019
- First submitted
- 22 Nov 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Analgesia in Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT03354806
- Acronym / sponsor ID
- DIALOXY / 2016/CHU/05
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: january 2019
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
Chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in diabetics. The later stages induce pain at rest and trophic disorders (ulcer, gangrene) that lead to chronic limb ischemia. Without possible surgical revascularization ,pain management and tissue healing are used to avoid amputation.
Prevalence of diabetes is twice higher in Reunion Island than in metropolitan France. As a consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the inferior limbs, is also increases.
This study compares the efficiency of two analgesic treatments in diabetics with forefoot injuries.
Detailed description
Patients are allocated in two groups regarding :
- their eligibility to analgesic treatment using continuous peripheral nerve blocks
- the unability of usual pain management to reduce their pain (pain visual analogic scale equal to or more than 4).
When patient 's response to pharmacological analgesic treatment is sufficient (pain visual analogic scale equal to or less than 3), patient is allocated to the control group.
Patients of experimental group received a continous analgesic treatment for 6 weeks using ropivacaine (2mg/ml, flow rate 7 ml/h).
Patients of control group received an analgesic treatment according the recommended pain ladder of World Health Organization (WHO). Opioids for mild-to-moderate pain are used in combination with a non-opioid analgesic, such as paracetamol, at the second step of the ladder. If regular maximum doses of opioids for mild-to-moderate pain do not achieve adequate analgesia, then they should be replaced with an opioid for moderate-to-severe pain, such as morphine.
Efficiency of both treatment is assessed the improvement of oxygen level in the tissue below the skin of the injured forefoot through the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative, monocentric study including 2 parallel groups. Patient's allocation is based on recommended criteria for catheters for continuous peripheral nerve blocks uses such as anlagesic treatment (ropivacain) tolerance and acceptance or analgesic treatment refusal
| Arm | Type | Receives |
|---|---|---|
| Continuous peripheral nerve blocks | Experimental | Procedure: Continuous peripheral nerve blocksRopivacaine-continous treatment using catheters for continous sciatic nerve blocks |
| Analgesic treatment | Active comparator | Procedure: Analgesic treatmentPharmacological pain management in accordance with WHO's pain relief ladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized patient
- Diabetics with chronic obliterative arteriopathy of the inferior limbs
- Permanent limb ischaemia with a TcPO2 of the front-foot of at least 10 mmHg under atmospheric conditions
- Lack of surgical revascularization
- No contraindication to hyperbaric therapy
Key exclusion criteria (3 listed)
- Contraindication to ropivacaine
- Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency)
- patients with planned limb amputation
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 |
|---|---|---|
| Continuous peripheral nerve blocks6 weeks-ropivacaine treatment delivered by continuous peripheral nerve blocks Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions | Procedure or surgery | Continuous peripheral nerve blocks |
| Analgesic treatment6 weeks-analgesic treatment according to WHO's pain relief ladder Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions | Procedure or surgery | Analgesic treatment |
Primary outcome
Foot tissue oxygenation on day 2
Time frame: on day 2
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
3 secondary outcomes
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Time frame: on day 2
Foot tissue oxygenation on week 6
Time frame: on week 6
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Time frame: on week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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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.
Valérie NAKAMURA, MD principal investigator
Centre Hpospitalier Universitaire de La REUNION
Questions about this trial
What is this clinical trial studying?
A study testing Continuous peripheral nerve blocks and Analgesic treatment in people with Diabetic Neuropathy Peripheral and Neuropathic Pain, run by Centre Hospitalier Universitaire de la Réunion.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 7 Mar 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Foot tissue oxygenation on day 2 (time frame: on day 2). 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 7 Mar 2019.