Clinical trial NCT03354806: Peripheral Analgesia in Painful Diabetic Neuropathy
Official title: Peripheral Analgesia in Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Neuropathy Peripheral
Neuropathic Pain
Diabetic Foot Infection
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Foot tissue oxygenation on day 2
timeFrame: on day 2
Secondary outcomes:
measure: Foot tissue oxygenation in hyperaemia-induced condition on day 2
timeFrame: on day 2
measure: Foot tissue oxygenation on week 6
timeFrame: on week 6
measure: Foot tissue oxygenation in hyperaemia-induced condition on day 2
timeFrame: on week 6
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hpospitalier Universitaire de La REUNION
name: Valérie NAKAMURA, MD
role: PRINCIPAL_INVESTIGATOR
References: