Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (january 2019)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

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.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Neuropathic Pain Diabetic Foot Infection Procedure: Continuous peripheral nerve blocks Procedure: Analgesic treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Official Title: Peripheral Analgesia in Painful Diabetic Neuropathy
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous peripheral nerve blocks
Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
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

Active Comparator: Analgesic treatment
Pharmacological pain management in accordance with WHO's pain relief ladder
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




Primary Outcome Measures :
  1. Foot tissue oxygenation on day 2 [ Time Frame: on day 2 ]
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions


Secondary Outcome Measures :
  1. Foot tissue oxygenation in hyperaemia-induced condition on day 2 [ Time Frame: on day 2 ]
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions

  2. Foot tissue oxygenation on week 6 [ Time Frame: on week 6 ]
    Measurement of transcutaneous oxygen tension (TcPO2) at room conditions

  3. Foot tissue oxygenation in hyperaemia-induced condition on day 2 [ Time Frame: on week 6 ]
    Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354806


Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
Layout table for investigator information
Principal Investigator: Valérie NAKAMURA, MD Centre Hpospitalier Universitaire de La REUNION
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT03354806    
Other Study ID Numbers: 2016/CHU/05
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Diabetic Foot
Neuromuscular Diseases
Nervous System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs