Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)
Primary Purpose
Diabetic Neuropathy Peripheral, Neuropathic Pain, Diabetic Foot Infection
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous peripheral nerve blocks
Analgesic treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Neuropathy Peripheral
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuous peripheral nerve blocks
Analgesic treatment
Arm Description
Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
Pharmacological pain management in accordance with WHO's pain relief ladder
Outcomes
Primary Outcome Measures
Foot tissue oxygenation 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
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Foot tissue oxygenation on week 6
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Full Information
NCT ID
NCT03354806
First Posted
November 22, 2017
Last Updated
March 6, 2019
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT03354806
Brief Title
Peripheral Analgesia in Painful Diabetic Neuropathy
Acronym
DIALOXY
Official Title
Peripheral Analgesia in Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
january 2019
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral, Neuropathic Pain, Diabetic Foot Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous peripheral nerve blocks
Arm Type
Experimental
Arm Description
Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks
Arm Title
Analgesic treatment
Arm Type
Active Comparator
Arm Description
Pharmacological pain management in accordance with WHO's pain relief ladder
Intervention Type
Procedure
Intervention Name(s)
Continuous peripheral nerve blocks
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Analgesic treatment
Intervention Description
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 Measure Information:
Title
Foot tissue oxygenation on day 2
Description
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Time Frame
on day 2
Secondary Outcome Measure Information:
Title
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Description
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Time Frame
on day 2
Title
Foot tissue oxygenation on week 6
Description
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
Time Frame
on week 6
Title
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Description
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
Time Frame
on week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie NAKAMURA, MD
Organizational Affiliation
Centre Hpospitalier Universitaire de La REUNION
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Peripheral Analgesia in Painful Diabetic Neuropathy
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