Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT02691234
Status:
UNKNOWN
Last Update Posted:
2016-02-25
First Post:
2016-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D003646', 'term': 'Debridement'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-02-21', 'studyFirstSubmitDate': '2016-01-31', 'studyFirstSubmitQcDate': '2016-02-21', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcers']}, 'descriptionModule': {'briefSummary': 'Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis.\n\nThe present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Inclusion Criteria:\n\n 1. Chronic non-healing diabetic foot ulcers for more than 2 months.\n 2. Age 18-80 years\n 3. Ankle Brachial Index (ABI) ≥0.6\n 4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm\n 5. The target ulcer is up to Wagner's grade 3\n 6. Albumin level ≥25g/L\n 7. Hemoglobin level ≥90g/L\n 8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2\n 9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements\n* Exclusion Criteria:\n\n 1. Pregnancy or lactation\n 2. ABI \\<0.6\n 3. The long diameter of the target ulcer is \\>7cm and the short diameter is \\<1cm\n 4. The target ulcer is of Wagner's grade 4 or above\n 5. Severe Hypoalbuminemia \\<25g/L\n 6. Severe anemia, Hemoglobin level \\<90g/L\n 7. eGFR \\<30ml/min/1.73m2\n 8. Patients suffering from acute Charcot foot\n 9. Severe edema of the treated limb\n 10. Patient with present malignancy or past malignancy in the treated area\n 11. Systemic chemotherapy/ radiation treatment within the last 6 months\n 12. Deep vein thrombosis within the last 6 months\n 13. Any other experimental treatment or participation in other studies\n\n \\-"}, 'identificationModule': {'nctId': 'NCT02691234', 'briefTitle': 'Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': '0592-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracorporeal Shockwave Therapy and debridement', 'description': 'The treatment will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing before each treatment. The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy and debridement', 'Other: debridement and cleaning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'debridement and cleansing.', 'description': 'The standard treatment to the control group and the treatment group will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing. The physician will treat the patient in regard to his medical state: antibiotic medication if needed, dressing and off loading with Orthotic devices', 'interventionNames': ['Other: debridement and cleaning']}], 'interventions': [{'name': 'Extracorporeal Shockwave Therapy and debridement', 'type': 'DEVICE', 'armGroupLabels': ['Extracorporeal Shockwave Therapy and debridement']}, {'name': 'debridement and cleaning', 'type': 'OTHER', 'armGroupLabels': ['Extracorporeal Shockwave Therapy and debridement', 'debridement and cleansing.']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}