DIALOXY: Peripheral Analgesia in Painful Diabetic Neuropathy

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03354806

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy Peripheral Neuropathic Pain Diabetic Foot Infection	Procedure: Continuous peripheral nerve blocks Procedure: Analgesic treatment	N/A

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 Design

Study Type:

Interventional

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 refusalComparative, 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

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT03354806

Other Study ID Numbers:

2016/CHU/05

First Posted:

Nov 28, 2017

Last Update Posted:

Mar 7, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Neuralgia

Diabetic Neuropathies

Diabetic Foot

Analgesics

Study Results

No Results Posted as of Mar 7, 2019