Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-02-27 @ 10:01 AM
Study NCT ID:
NCT03354806
Status:
WITHDRAWN
Last Update Posted:
2019-03-07
First Post:
2017-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Analgesia in Painful Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'january 2019', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Foot tissue oxygenation on day 2', 'timeFrame': 'on day 2', 'description': 'Measurement of transcutaneous oxygen tension (TcPO2) at room conditions'}], 'secondaryOutcomes': [{'measure': 'Foot tissue oxygenation in hyperaemia-induced condition on day 2', 'timeFrame': 'on day 2', 'description': 'Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions'}, {'measure': 'Foot tissue oxygenation on week 6', 'timeFrame': 'on week 6', 'description': 'Measurement of transcutaneous oxygen tension (TcPO2) at room conditions'}, {'measure': 'Foot tissue oxygenation in hyperaemia-induced condition on day 2', 'timeFrame': 'on week 6', 'description': 'Measurement of transcutaneous oxygen tension (TcPO2) under hyperbaric conditions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Neuropathy Peripheral', 'Neuropathic Pain', 'Diabetic Foot Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nPrevalence 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.\n\nThis study compares the efficiency of two analgesic treatments in diabetics with forefoot injuries.', 'detailedDescription': "Patients are allocated in two groups regarding :\n\n* their eligibility to analgesic treatment using continuous peripheral nerve blocks\n* the unability of usual pain management to reduce their pain (pain visual analogic scale equal to or more than 4).\n\nWhen 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.\n\nPatients of experimental group received a continous analgesic treatment for 6 weeks using ropivacaine (2mg/ml, flow rate 7 ml/h).\n\nPatients 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.\n\nEfficiency of both treatment is assessed the improvement of oxygen level in the tissue below the skin of the injured forefoot through the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patient\n* Diabetics with chronic obliterative arteriopathy of the inferior limbs\n* Permanent limb ischaemia with a TcPO2 of the front-foot of at least 10 mmHg under atmospheric conditions\n* Lack of surgical revascularization\n* No contraindication to hyperbaric therapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Contraindication to ropivacaine\n* Conditions that could alter hyperbaric measurements (anemia \\< 8 g/dl, cardiac or respiratory insufficiency)\n* patients with planned limb amputation'}, 'identificationModule': {'nctId': 'NCT03354806', 'acronym': 'DIALOXY', 'briefTitle': 'Peripheral Analgesia in Painful Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Peripheral Analgesia in Painful Diabetic Neuropathy', 'orgStudyIdInfo': {'id': '2016/CHU/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous peripheral nerve blocks', 'description': 'Ropivacaine-continous treatment using catheters for continous sciatic nerve blocks', 'interventionNames': ['Procedure: Continuous peripheral nerve blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Analgesic treatment', 'description': "Pharmacological pain management in accordance with WHO's pain relief ladder", 'interventionNames': ['Procedure: Analgesic treatment']}], 'interventions': [{'name': 'Continuous peripheral nerve blocks', 'type': 'PROCEDURE', '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', 'armGroupLabels': ['Continuous peripheral nerve blocks']}, {'name': 'Analgesic treatment', 'type': 'PROCEDURE', '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", 'armGroupLabels': ['Analgesic treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Valérie NAKAMURA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hpospitalier Universitaire de La REUNION'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}