Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT05426161
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2022-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-center, prospective, exploratory study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Wound status- Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection.', 'timeFrame': 'Throughout the trial (12-15 weeks)', 'description': 'Semi-quantitatively measured (Absent/Low \\< 25 %, Mild 25-50 %, Moderate 51-75 %, High \\> 75%)'}], 'primaryOutcomes': [{'measure': 'Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41', 'timeFrame': '3 to 6 weeks after first injection of Botulinum toxin a', 'description': 'At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41'}], 'secondaryOutcomes': [{'measure': 'Absolute and percentage change in the area of hyperalgesia and allodynia', 'timeFrame': '3 to15 weeks after first injection of Botulinum toxin a.', 'description': 'Area of hyperalgesia and allodynia will be assessed at D0, D21/41 and D90/110'}, {'measure': 'Absolute and percentage change of the ulcer area.', 'timeFrame': 'Throughout the trial (12-15 weeks)', 'description': 'The ulcer size will be measured at every visit with study day 0 as baseline.'}, {'measure': 'Clinical improvement of the wound healing process', 'timeFrame': 'Throughout the trial (12-15 weeks)', 'description': 'Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)'}, {'measure': 'Therapeutic doses of Botulinum toxin a to treat wound pain', 'timeFrame': '3 and 6 weeks after first injection', 'description': 'Number of patients who need a second injection of Botulinum toxin a on study D21 if mean VAS (D19-21) are similar (± 10 %) to the pre-injection mean VAS at D0'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Throughout the trial (12-15 weeks)', 'description': 'All clinical adverse events will be assessed and recorded.'}, {'measure': 'Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a', 'timeFrame': 'Analysis within 1 year after study completion', 'description': 'Changes in the levels of cytokine and pain related substances will be quantified over time (throughout the trial). Prospects to analyse i.g ( IL-6, NGF, IL-1β) with either MSD,Luminex or ELISA.\n\nThe results will be expressed as pg/ mg.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Botulinum toxin A'], 'conditions': ['Chronic Pain', 'Lower Extremity Wound']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Lower extremity ulcer ≥ 4 weeks.\n3. Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2\n4. Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).\n5. Normal monofilament and vibration test in lower extremities.\n6. Patients who can fill out pain diary correctly.\n7. Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.\n\nExclusion Criteria:\n\n1\\. Infection at injection site. 2. Hypersensitivity to botulinum toxin A. 3. Peripheral neuropathy. 3. Diabetic foot ulcer. 4. Unstable critic peripheral ischemia judged by investigator 5. Exposed capsule, tendon, muscle or bone in the ulcers. 6. Tunnelling, undermining or sinus tracts. 7. Disorders of the neuromuscular junction (e.g. Myasthenia). 8. Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion.\n\n9\\. Pregnant or lactating woman and woman with childbearing potential but does not use contraception.\n\n10\\. Judgment by the investigator that the patient is not suited for study participation.'}, 'identificationModule': {'nctId': 'NCT05426161', 'briefTitle': 'The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study', 'orgStudyIdInfo': {'id': 'Botox-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum Toxin A', 'description': 'Open-label study', 'interventionNames': ['Drug: Botulinum Toxin A']}], 'interventions': [{'name': 'Botulinum Toxin A', 'type': 'DRUG', 'description': 'Botulinum Toxin A (10 units per cm2 wound areal) will be injected subcutaneously around the wound (1-2 cm from wound edge) maximum 200 units at each injection time.The total dose of BoNTA is maximum 400 units. Patient will receive one or two treatments in total.', 'armGroupLabels': ['Botulinum Toxin A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Simon Francis Thomsen, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator, MD', 'investigatorFullName': 'Lubna Sabah, MD', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}