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Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)

Primary Purpose

Diabetic Neuropathy Peripheral, Neuropathic Pain, Diabetic Foot Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous peripheral nerve blocks
Analgesic treatment
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Neuropathy Peripheral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindication to ropivacaine
  • Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency)
  • patients with planned limb amputation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Continuous peripheral nerve blocks

    Analgesic treatment

    Arm Description

    Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks

    Pharmacological pain management in accordance with WHO's pain relief ladder

    Outcomes

    Primary Outcome Measures

    Foot tissue oxygenation on day 2
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions

    Secondary Outcome Measures

    Foot tissue oxygenation in hyperaemia-induced condition on day 2
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
    Foot tissue oxygenation on week 6
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
    Foot tissue oxygenation in hyperaemia-induced condition on day 2
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions

    Full Information

    First Posted
    November 22, 2017
    Last Updated
    March 6, 2019
    Sponsor
    Centre Hospitalier Universitaire de la Réunion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03354806
    Brief Title
    Peripheral Analgesia in Painful Diabetic Neuropathy
    Acronym
    DIALOXY
    Official Title
    Peripheral Analgesia in Painful Diabetic Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    january 2019
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de la Réunion

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Neuropathy Peripheral, Neuropathic Pain, Diabetic Foot Infection

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous peripheral nerve blocks
    Arm Type
    Experimental
    Arm Description
    Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
    Arm Title
    Analgesic treatment
    Arm Type
    Active Comparator
    Arm Description
    Pharmacological pain management in accordance with WHO's pain relief ladder
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous peripheral nerve blocks
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Analgesic treatment
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Foot tissue oxygenation on day 2
    Description
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
    Time Frame
    on day 2
    Secondary Outcome Measure Information:
    Title
    Foot tissue oxygenation in hyperaemia-induced condition on day 2
    Description
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
    Time Frame
    on day 2
    Title
    Foot tissue oxygenation on week 6
    Description
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
    Time Frame
    on week 6
    Title
    Foot tissue oxygenation in hyperaemia-induced condition on day 2
    Description
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
    Time Frame
    on week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Contraindication to ropivacaine Conditions that could alter hyperbaric measurements (anemia < 8 g/dl, cardiac or respiratory insufficiency) patients with planned limb amputation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valérie NAKAMURA, MD
    Organizational Affiliation
    Centre Hpospitalier Universitaire de La REUNION
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Peripheral Analgesia in Painful Diabetic Neuropathy

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