Diabetic Foot UlcerNCT07444593
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
A study testing Biodynamik XT3 in people with Diabetic Foot Ulcer and Chronic Ulcers of the Lower Limb, run by Biodynamik, Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
- What is being tested?
- Biodynamik XT3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>=22 years).
- Chronic diabetic foot ulcer wound persisting >=12 weeks and less than 104 weeks refractory to standard wound care.
- Wound location within distal 1/3 tibia and below including foot.
- Wound stages: WiFi >= 3
- At least one patent lower extremity tibial vessel (after revascularization if needed).
- Able to provide informed consent and comply with study procedures.
Who cannot join
- Active systemic infection (positive blood cultures)
- Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)
- Subacute lower extremity wound <12 weeks with or without standard wound cares
- Internal hardware within 10cm of possible TTT placement
- Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement
- End Stage Renal Disease requiring dialysis
Show all 26Show fewer
- Renal function values
- eGFR: <15ml/min and
- Creatinine: >6mg/dL and
- BUN: >50 mg/dL
- Lab values of Serum albumin less than 2.5 g/dL or hemoglobin less than 8.0 g/dL or platelet count less than 75,000/μL
- Wounds less than 1 cm3 or greater than 30 cm3
- Wounds that are circumferential as defined as a wound involving 360° of the limb circumference, with complete circumferential wounds defined as 360° involvement.
- Corticosteroids >10mg prednisone equivalent daily for >2 weeks
- Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
- TNF-inhibitors or JAK inhibitors or chemotherapy-dose methotrexate
- Cognitive or social limitations precluding consent or follow-up
- Current participation in another investigational study (drug or device)
- Immunocompromised (WBC <4) or undergoing active chemotherapy
- Hemoglobin A1c >10
- BMI <18.5 kg/m2
- Pregnant, lactating, or planning to become pregnant
- Severe hepatic impairment defined by patient on a transplant list, MELD > 20 or Child's class C.
- A history of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process.
- Active local wound infection as defined by erythema greater than 0.5 cm from the wound margin AND at least one other localized sign of inflammation (purulent discharge, induration, localized warmth, or pain/tenderness)
- Life expectancy less than 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren Evans contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Lauren Evans, 904-953-5416, evans.lauren2@mayo.edu
Bre Jenkins, jenkins.breana@mayo.edu
About this study
Official title: SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study
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.
Read the detailed description
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.
Transverse 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.
- Being tested
- Biodynamik XT3
- Keywords
- Transverse Bone Transport, DFU, TTT, Biodynamik, XT3
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodynamik XT3Device
Application of XT3 system and transverse tibial bone transport procedure
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (control) | No intervention | Standard Wound Care |
| Standard Wound Care plus TTT | Experimental | Not described Receives: Device: Biodynamik XT3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with wound closure
To demonstrate the safety and effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic diabetic foot ulcers, specifically, to demonstrate that the proportion of subjects with wound closure is greater for the investigational procedure than standard wound care alone at 18 weeks while maintaining an acceptable safety profile. Proportion of subjects with wound closure as defined as 100% re-epithelialization of the target diabetic foot ulcer where there is no drainage or dressing is not required and confirmed at two consecutive study visits 2 weeks apart.
Measured: From enrollment to 18 weeks
Secondary outcomes (11)
Proportion of patients with PAR of greater than 60% at 8 and 18 weeks.
The proportion of patients between each cohort who achieve a Percent Area Reduction of greater than 60%
Measured: At 8 and 18 weeks
Mean PAR summarized at 8 and 18 weeks
To compare mean Percent Area Reduction (PAR) between treatment groups at 8 and 18 weeks
Measured: From enrollment to 18 weeks
Frequency of subsequent procedures
Frequency of subsequent procedures (surgical debridement; minor/major amputation)
Measured: From enrollment to 18 weeks
Time to achieve wound closure
Compare the time to achieve wound closure at 18 weeks and through 12 months
Measured: Enrollment through 18 weeks and 12 months
Vascular changes as measured by Ankle Brachial Index (ABI)
ABI (No units; ratio) at 18 weeks and at 6, 9 and 12 months
Measured: From enrollment to 18 weeks, 6, 9 and 12 months
Improvement in Visual Analog Scale to measure pain
Improvement in pain as measured in a 10 point Visual Analogue Scale (VAS) at 8 and 18 weeks. VAS lowest score is 0 (no pain). While 10 is the highest score (worst pain).
Measured: From enrollment to 18 weeks
Frequency of wound recurrence
Frequency of wound recurrence/re-ulceration at 12 weeks and at 6, 9 and 12 months
Measured: Enrollment until 12 months
Amputation free survival
Amputation free survival at 12 weeks and at 6, 9 and 12 months
Measured: Enrollment until 12 months
Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2)
TcPO2 (mmHG) at 6 weeks, 18 weeks and at 6, 9 and 12 months. Oxygen tension at the skin surface, reflecting tissue oxygenation and perfusion.
Measured: Measured at baseline to 18 weeks and through 12 months
Improvement in Patient Reported Outcome Wound-QoL-17 at 18 weeks
Improvement in Quality of Life Measure Wound-QoL-17 at 18 weeks. Score (0-4 mean or 0-68 total; Transformed score 0-100
Measured: From enrollment to 18 weeks
Time to heal for surgical site
Time to heal for pin sites, incision sites and bone consolidation
Measured: Enrollment to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biodynamik, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Elizabeth Wellings, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444593
- Sponsor's protocol ID
- BD-TTT-001
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33344165Chen 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.
PubMed 31794478Luxon 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.
PubMed 40567177Chen 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.
PubMed 36263383Ding 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.
PubMed 39243174Liao 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.
PubMed 41608106Ou 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.
PubMed 35946439Hu 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.
PubMed 36686461
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study
- ClinicalTrials.gov ID
- NCT07444593
- Acronym / sponsor ID
- BD-TTT-001
- Keywords
- Transverse Bone Transport, DFU, TTT, Biodynamik, XT3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Biodynamik, IncIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Transverse 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (control) | No intervention | –Standard Wound Care |
| Standard Wound Care plus TTT | Experimental | Device: Biodynamik XT3 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (>=22 years).
- Chronic diabetic foot ulcer wound persisting >=12 weeks and less than 104 weeks refractory to standard wound care.
- Wound location within distal 1/3 tibia and below including foot.
- Wound stages: WiFi >= 3
- At least one patent lower extremity tibial vessel (after revascularization if needed).
Key exclusion criteria (26 listed)
- Active systemic infection (positive blood cultures)
- Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)
- Subacute lower extremity wound <12 weeks with or without standard wound cares
- Internal hardware within 10cm of possible TTT placement
- Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodynamik XT3Application of XT3 system and transverse tibial bone transport procedure | Device | Standard Wound Care plus TTT |
Primary outcome
Proportion of subjects with wound closure
Time frame: From enrollment to 18 weeks
To demonstrate the safety and effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic diabetic foot ulcers, specifically, to demonstrate that the proportion of subjects with wound closure is greater for the investigational procedure than standard wound care alone at 18 weeks while maintaining an acceptable safety profile. Proportion of subjects with wound closure as defined as 100% re-epithelialization of the target diabetic foot ulcer where there is no drainage or dressing is not required and confirmed at two consecutive study visits 2 weeks apart.
11 secondary outcomes
Proportion of patients with PAR of greater than 60% at 8 and 18 weeks.
Time frame: At 8 and 18 weeks
Mean PAR summarized at 8 and 18 weeks
Time frame: From enrollment to 18 weeks
Frequency of subsequent procedures
Time frame: From enrollment to 18 weeks
Time to achieve wound closure
Time frame: Enrollment through 18 weeks and 12 months
Vascular changes as measured by Ankle Brachial Index (ABI)
Time frame: From enrollment to 18 weeks, 6, 9 and 12 months
Improvement in Visual Analog Scale to measure pain
Time frame: From enrollment to 18 weeks
Frequency of wound recurrence
Time frame: Enrollment until 12 months
Amputation free survival
Time frame: Enrollment until 12 months
Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2)
Time frame: Measured at baseline to 18 weeks and through 12 months
Improvement in Patient Reported Outcome Wound-QoL-17 at 18 weeks
Time frame: From enrollment to 18 weeks
Time to heal for surgical site
Time frame: Enrollment to 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 33344165Nie 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.
- Background: PubMed 31794478Chen 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.
- Background: PubMed 40567177Luxon 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.
- Background: PubMed 36263383Chen 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.
- Background: PubMed 39243174Ding 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.
- Background: PubMed 41608106Liao 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.
- Background: PubMed 35946439Ou 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.
- Background: PubMed 36686461Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Evans contact
Elizabeth Wellings principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodynamik XT3 in people with Diabetic Foot Ulcer and Chronic Ulcers of the Lower Limb, run by Biodynamik, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Wellings, MD (9049532496, Wellings.elizabeth@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with wound closure (time frame: From enrollment to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444593, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.