Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)
|ClinicalTrials.gov Identifier: NCT03354806|
Recruitment Status : Withdrawn (january 2019)
First Posted : November 28, 2017
Last Update Posted : March 7, 2019
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|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
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
- Foot tissue oxygenation on day 2 [ Time Frame: on day 2 ]Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354806
|Principal Investigator:||Valérie NAKAMURA, MD||Centre Hpospitalier Universitaire de La REUNION|