Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)

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.

Study Overview

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous peripheral nerve blocks
Ropivacaine-continous treatment using catheters for continous sciatic 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
Active Comparator: Analgesic treatment
Pharmacological pain management in accordance with WHO's pain relief ladder
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot tissue oxygenation on day 2
Time Frame: on day 2
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
on day 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Valérie NAKAMURA, MD, Centre Hpospitalier Universitaire de La REUNION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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