Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 6:00 AM
Study NCT ID:
NCT07438795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D000673', 'term': 'Amputation, Traumatic'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001753', 'term': 'Blast Injuries'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001469', 'term': 'Barotrauma'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent Clinically Significant Residual Limb Pain', 'timeFrame': '3 months', 'description': 'Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.'}], 'secondaryOutcomes': [{'measure': 'Persistent Residual Limb Pain at 6 Months', 'timeFrame': '6 months', 'description': 'NRS ≥4 at rest or during movement at 6 months after amputation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic amputation', 'stump infection', 'residual limb pain', 'chronic pain', 'surgical site infection', 'blast injury', 'neuropathic pain'], 'conditions': ['Residual Limb Pain', 'Stump Pain', 'Post-Amputation Pain', 'Surgical Site Infection', 'Phantom Limb Pain (PLP)']}, 'descriptionModule': {'briefSummary': 'Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.', 'detailedDescription': 'Patients undergoing traumatic limb amputation will be enrolled within 4 weeks after surgery and followed for 6 months. Early postoperative stump infection will be recorded using predefined clinical criteria. Pain intensity (Numeric Rating Scale), neuropathic pain screening (DN4), and phantom limb pain will be assessed at baseline, 3 months, and 6 months. Multivariable logistic regression will be used to evaluate whether stump infection is independently associated with persistent residual limb pain, adjusting for amputation level, injury mechanism, revision surgeries, antibiotic exposure, and demographic factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult patients (≥18 years) undergoing traumatic upper or lower limb amputation following blast-related, drone-related, or other high-energy injuries. Participants will be enrolled within 4 weeks after primary amputation surgery and followed prospectively for 6 months. The population represents individuals at risk of developing persistent residual limb pain during the early postoperative and rehabilitation period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic upper or lower limb amputation\n* Enrollment within 4 weeks after surgery\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pre-existing chronic pain in the affected limb\n* Severe cognitive impairment\n* Terminal illness limiting follow-up\n* Refusal or inability to complete follow-up assessments'}, 'identificationModule': {'nctId': 'NCT07438795', 'acronym': 'INF-STUMP-PAIN', 'briefTitle': 'Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Ukrainian Society of Regional Anesthesia and Pain Therapy'}, 'officialTitle': 'Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '23V0223022026'}, 'secondaryIdInfos': [{'id': 'USRA', 'type': 'OTHER', 'domain': 'Ukranian Society of Regional Anesthesia and Pain Therapy'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stump Infection', 'description': 'Participants who develop postoperative stump infection within 30 days after amputation, defined by clinical signs of infection requiring antibiotic therapy and/or surgical revision.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dmytro Dmytriiev, PhD.Professor', 'role': 'CONTACT', 'email': 'mddmytriiev@gmail.com', 'phone': '+380674309449'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ukrainian Society of Regional Anesthesia and Pain Therapy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Dmytro Dmytriiev', 'investigatorAffiliation': 'Ukrainian Society of Regional Anesthesia and Pain Therapy'}}}}