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Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354806
Recruitment Status : Withdrawn (january 2019)
First Posted : November 28, 2017
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date March 7, 2019
Estimated Study Start Date  ICMJE June 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
Foot tissue oxygenation on day 2 [ Time Frame: on day 2 ]
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • Foot tissue oxygenation in hyperaemia-induced condition on day 2 [ Time Frame: on day 2 ]
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
  • Foot tissue oxygenation on week 6 [ Time Frame: on week 6 ]
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
  • Foot tissue oxygenation in hyperaemia-induced condition on day 2 [ Time Frame: on week 6 ]
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peripheral Analgesia in Painful Diabetic Neuropathy
Official Title  ICMJE Peripheral Analgesia in Painful Diabetic Neuropathy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetic Neuropathy Peripheral
  • Neuropathic Pain
  • Diabetic Foot Infection
Intervention  ICMJE
  • Procedure: Continuous peripheral nerve blocks
    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
  • Procedure: Analgesic treatment
    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 Arms  ICMJE
  • Experimental: Continuous peripheral nerve blocks
    Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
    Intervention: Procedure: Continuous peripheral nerve blocks
  • Active Comparator: Analgesic treatment
    Pharmacological pain management in accordance with WHO's pain relief ladder
    Intervention: Procedure: Analgesic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
68
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354806
Other Study ID Numbers  ICMJE 2016/CHU/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de la Réunion
Study Sponsor  ICMJE Centre Hospitalier Universitaire de la Réunion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valérie NAKAMURA, MD Centre Hpospitalier Universitaire de La REUNION
PRS Account Centre Hospitalier Universitaire de la Réunion
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP