Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:02 AM
Study NCT ID:
NCT07444593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Wound Closure', 'timeFrame': 'From enrollment to 16 weeks', 'description': 'To demonstrate the effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic lower extremity wounds, specifically, to demonstrate that the time to achieving wound closure is faster for the investigational procedure than standard wound care alone.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Area Reduction (PAR) at 16 weeks', 'timeFrame': 'From enrollment to 16 weeks', 'description': 'To compare mean Percent Area Reduction (PAR) between treatment groups at 16 weeks'}, {'measure': 'Proportion of patients with wound closure', 'timeFrame': 'From enrollment until 16 weeks', 'description': 'To compare the proportion of patients with wound closure between treatment groups, defined as full epithelialization of the reference wound without drainage.'}, {'measure': 'Frequency of subsequent procedures', 'timeFrame': 'From enrollment to 16 weeks', 'description': 'Frequency of subsequent procedures (surgical debridement; minor/major amputation)'}, {'measure': 'Vascular changes as measured by Ankle Brachial Index (ABI) measured as mmHg/mmHg', 'timeFrame': 'From enrollment to 16 weeks, 6, 9 and 12 months', 'description': 'ABI and TcPO2 at 16 weeks and at 6, 9 and 12 months'}, {'measure': 'Plasma growth factor level changes as measured by VEGf at 16 weeks and at 6,9 and 12 months', 'timeFrame': 'From enrollment until 12 months', 'description': 'Vascular Endothelial Growth Factor) measured in either picograms per milliliter (pg/mL) or nanograms per liter (ng/L) in serum or plasma'}, {'measure': 'Improvement in Visual Analog Scale to measure pain', 'timeFrame': 'From enrollment to 16 weeks', 'description': 'Improvement in pain as measured in a 10 point VAS scale at 16 weeks'}, {'measure': 'Frequency of wound recurrence', 'timeFrame': 'Enrollment until 12 months', 'description': 'Frequency of wound recurrence/re-ulceration at 12 weeks and at 6, 9 and 12 months'}, {'measure': 'Amputation free survival', 'timeFrame': 'Enrollment until 12 months', 'description': 'Amputation free survival at 12 weeks and at 6, 9 and 12 months'}, {'measure': 'Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2)', 'timeFrame': 'Measured at baseline to 16 weeks', 'description': 'Measuring oxygen pressure in the limb in mmHG'}, {'measure': 'Vascular Perfusion measured by Computed Tomography Angiogram (CTA) at 16 weeks and at 6, 9 and 12 months', 'timeFrame': 'Through 12 months', 'description': 'CTA is measured in Hounsfield Units (HU)'}, {'measure': 'Improvement in Patient Reported Outcome Wound-QoL-17 at 16 weeks', 'timeFrame': 'From enrollment to 16 weeks', 'description': 'Improvement in Quality of Life Measure Wound-QoL-17 at 16 weeks using a composite 100 point scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transverse Bone Transport', 'DFU', 'TTT', 'Biodynamik', 'XT3'], 'conditions': ['Diabetic Foot Ulcer', 'Chronic Ulcers of the Lower Limb']}, 'referencesModule': {'references': [{'pmid': '33344165', 'type': 'BACKGROUND', 'citation': 'Nie X, Kuang X, Liu G, Zhong Z, Ding Y, Yu J, Liu J, Li S, He L, Su H, Qin W, Zhao J, Hua Q, Chen Y. Tibial cortex transverse transport facilitating healing in patients with recalcitrant non-diabetic leg ulcers. J Orthop Translat. 2020 Dec 9;27:1-7. doi: 10.1016/j.jot.2020.11.001. eCollection 2021 Mar.'}, {'pmid': '31794478', 'type': 'BACKGROUND', 'citation': 'Chen Y, Kuang X, Zhou J, Zhen P, Zeng Z, Lin Z, Gao W, He L, Ding Y, Liu G, Qiu S, Qin A, Lu W, Lao S, Zhao J, Hua Q. Proximal Tibial Cortex Transverse Distraction Facilitating Healing and Limb Salvage in Severe and Recalcitrant Diabetic Foot Ulcers. Clin Orthop Relat Res. 2020 Apr;478(4):836-851. doi: 10.1097/CORR.0000000000001075.'}, {'pmid': '40567177', 'type': 'BACKGROUND', 'citation': 'Luxon A, Syziu A, Harrison WD, Islam A, Mason L. A Systematic Review on Tibial Cortex Transverse Transport in the Treatment of Ischemic Ulcers of the Lower Limb. Foot Ankle Int. 2025 Aug;46(8):914-924. doi: 10.1177/10711007251341312. Epub 2025 Jun 26.'}, {'pmid': '36263383', 'type': 'BACKGROUND', 'citation': 'Chen Y, Ding X, Zhu Y, Jia Z, Qi Y, Chen M, Lu J, Kuang X, Zhou J, Su Y, Zhao Y, Lu W, Zhao J, Hua Q. Effect of tibial cortex transverse transport in patients with recalcitrant diabetic foot ulcers: A prospective multicenter cohort study. J Orthop Translat. 2022 Oct 12;36:194-204. doi: 10.1016/j.jot.2022.09.002. eCollection 2022 Sep.'}, {'pmid': '39243174', 'type': 'BACKGROUND', 'citation': 'Ding Y, Yu D, Huang H, Peng X, Yang S, Lin Z, Zhou P, Liang J, Zou X, Mo R, Pan K, Zheng P, Kuang X, Nie X, Hua Q. Combining Tibial Cortex Transverse Transport (TTT) and Endovascular Therapy (EVT) for Limb Salvage in Chronic Limb-Threatening Ischemia. Orthop Surg. 2024 Sep;16(9):2132-2139. doi: 10.1111/os.14222. Epub 2024 Sep 7.'}, {'pmid': '41608106', 'type': 'BACKGROUND', 'citation': 'Liao MM, Zhang F, Wang YK, Wang MW, Cao JR, Jin ZH, Ren YJ, Chen S. Transverse tibial bone transport promotes distraction osteogenesis and improves blood flow in the management of diabetic foot. World J Diabetes. 2026 Jan 15;17(1):111847. doi: 10.4239/wjd.v17.i1.111847.'}, {'pmid': '35946439', 'type': 'BACKGROUND', 'citation': 'Ou S, Xu C, Yang Y, Chen Y, Li W, Lu H, Li G, Sun H, Qi Y. Transverse Tibial Bone Transport Enhances Distraction Osteogenesis and Vascularization in the Treatment of Diabetic Foot. Orthop Surg. 2022 Sep;14(9):2170-2179. doi: 10.1111/os.13416. Epub 2022 Aug 10.'}, {'pmid': '36686461', 'type': 'BACKGROUND', 'citation': 'Hu XX, Xiu ZZ, Li GC, Zhang JY, Shu LJ, Chen Z, Li H, Zou QF, Zhou Q. Effectiveness of transverse tibial bone transport in treatment of diabetic foot ulcer: A systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Jan 4;13:1095361. doi: 10.3389/fendo.2022.1095361. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.', 'detailedDescription': 'Diabetic lower extremity ulcers are associated with impaired blood flow, delayed wound healing, high morbidity, and an increased risk of limb loss. In some patients, conventional treatments such as wound care, revascularization procedures, or adjunctive therapies are ineffective or not feasible, leaving limited options short of major amputation.\n\nTransverse tibial bone transport (TTT) is a surgical technique that applies controlled distraction to the tibial cortex and has been reported in prior clinical studies to stimulate angiogenesis, improve local perfusion, and support wound healing in ischemic conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\>=22 years).\n* Chronic lower extremity wound persisting \\>=12 weeks and refractory to standard wound care.\n* Wound location within distal 1/3 tibia and below including foot.\n* Wound stages:\n\nWiFi \\>= 3\n\n* At least one patent lower extremity tibial vessel (after revascularization if needed).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Active systemic infection (positive blood cultures)\n* Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)\n* Subacute lower extremity wound \\<12 weeks with or without standard wound cares\n* Internal hardware within 10cm of possible TTT placement\n* Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement\n* End Stage Renal Disease requiring dialysis\n* Renal function values\n\n * eGFR: \\<15ml/min and\n * Creatinine: \\>6mg/dL and\n * BUN: \\>50 mg/dL\n* Corticosteroids \\>10mg prednisone equivalent daily for \\>2 weeks\n* Patients with osteomyelitis in the ipsilateral tibia of the corticotomy\n* Cognitive or social limitations precluding consent or follow-up\n* Current participation in another investigational study (drug or device)\n* Immunocompromised (WBC \\<4) or undergoing active chemotherapy\n* Hemoglobin A1c \\>12\n* Pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT07444593', 'briefTitle': 'Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biodynamik, Inc'}, 'officialTitle': 'SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study', 'orgStudyIdInfo': {'id': 'BD-TTT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (control)', 'description': 'Standard Wound Care'}, {'type': 'EXPERIMENTAL', 'label': 'Standard Wound Care plus TTT', 'interventionNames': ['Device: Biodynamik XT3']}], 'interventions': [{'name': 'Biodynamik XT3', 'type': 'DEVICE', 'description': 'Application of XT3 system and transverse tibial bone transport procedure', 'armGroupLabels': ['Standard Wound Care plus TTT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Lauren Evans', 'role': 'CONTACT', 'email': 'evans.lauren2@mayo.edu', 'phone': '904-953-5416'}, {'name': 'Bre Jenkins', 'role': 'CONTACT', 'email': 'jenkins.breana@mayo.edu'}, {'name': 'Elizabeth Wellings, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thea Price, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Elizabeth Wellings, MD', 'role': 'CONTACT', 'email': 'Wellings.elizabeth@mayo.edu', 'phone': '9049532496'}, {'name': 'Lauren Evans', 'role': 'CONTACT', 'email': 'evans.lauren2@mayo.edu'}], 'overallOfficials': [{'name': 'Elizabeth Wellings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biodynamik, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}