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Peripheral Analgesia in Painful Diabetic Neuropathy

NCT03354806 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy Peripheral
  • Neuropathic Pain
  • Diabetic Foot Infection

Interventions

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Principal Investigators

  • Valérie NAKAMURA, MD · Centre Hpospitalier Universitaire de La REUNION

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2019-09-30
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354806 on ClinicalTrials.gov