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Peripheral Analgesia in Painful Diabetic Neuropathy

Peripheral Analgesia in Painful Diabetic Neuropathy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354806
Acronym
DIALOXY
Enrollment
0
Registered
2017-11-28
Start date
2018-06-30
Completion date
2019-12-31
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Infection, Diabetic Neuropathy Peripheral, Neuropathic Pain

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.

Interventions

PROCEDUREContinuous 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

PROCEDUREAnalgesic 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

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Foot tissue oxygenation on day 2on day 2Measurement of transcutaneous oxygen tension (TcPO2) at room conditions

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026