- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03354806
Peripheral Analgesia in Painful Diabetic Neuropathy (DIALOXY)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous peripheral nerve blocks
Ropivacaine-continous treatment using catheters for continous sciatic 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot tissue oxygenation on day 2
Time Frame: on day 2
|
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
|
on day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Time Frame: on day 2
|
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
|
on day 2
|
Foot tissue oxygenation on week 6
Time Frame: on week 6
|
Measurement of transcutaneous oxygen tension (TcPO2) at room conditions
|
on week 6
|
Foot tissue oxygenation in hyperaemia-induced condition on day 2
Time Frame: on week 6
|
Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions
|
on week 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Valérie NAKAMURA, MD, Centre Hpospitalier Universitaire de La REUNION
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Skin Diseases
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Foot Ulcer
- Diabetic Foot
- Neuralgia
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Analgesics
Other Study ID Numbers
- 2016/CHU/05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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