Transverse Tibial Bone Transport for Diabetic Foot Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new technique called transverse tibial bone transport to determine its effectiveness in healing diabetic foot ulcers unresponsive to standard care. It evaluates the technique's success in wound healing and limb preservation for individuals with limited treatment options. The trial includes two groups: one receives standard wound care, while the other receives standard care plus the new bone transport technique. Individuals with a diabetic foot ulcer lasting over 12 weeks, unhealed by regular treatment, might be suitable candidates.
As an unphased trial, this study presents a unique opportunity to explore an innovative treatment that could offer new hope for healing.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking corticosteroids at a dose higher than 10mg of prednisone daily for more than 2 weeks, you may not be eligible to participate.
What prior data suggests that transverse tibial bone transport is safe for treating diabetic foot ulcers?
Research has shown that transverse tibial bone transport (TTT) is generally well-tolerated by patients. In one study, 94% of ulcers healed, and only 10% of patients experienced complications, indicating the treatment's effectiveness with minimal issues. Another study found that TTT improved blood flow and reduced pain, promising signs for its safety and effectiveness.
Although complications can occur, as with any medical procedure, the success rates and benefits reported in these studies suggest that TTT is a safe option for treating diabetic foot ulcers.12345Why are researchers excited about this trial?
Transverse Tibial Bone Transport is unique because it offers a novel approach to treating diabetic foot ulcers by promoting the body's natural ability to regenerate tissue. Unlike standard wound care, which typically involves cleaning, dressing, and sometimes antibiotics, this technique uses a mechanical method to encourage new bone and tissue growth in the affected area. Researchers are excited about this treatment because it has the potential to significantly accelerate healing and reduce the risk of complications, such as infections or amputations, that often accompany chronic diabetic foot ulcers. This innovative method could pave the way for more effective and faster recovery options for patients suffering from this debilitating condition.
What evidence suggests that transverse tibial bone transport is effective for diabetic foot ulcers?
Research has shown that transverse tibial bone transport may help treat diabetic foot ulcers. In this trial, some participants will receive standard wound care plus transverse tibial bone transport, while others will receive standard wound care alone. Studies have found that up to 96% of these ulcers healed within two years with transverse tibial bone transport. Additionally, up to 98% of patients retained their limbs. This treatment improves blood flow and skin temperature, which are crucial for healing. Most patients experience less pain and better foot function after the procedure. Overall, this technique could be a valuable option for those with limited choices for managing severe diabetic foot ulcers.23567
Who Is on the Research Team?
Elizabeth Wellings
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults aged 22 or older with a chronic diabetic foot or lower leg ulcer that hasn't healed after at least 12 weeks of standard care. The wound must be on the lower third of the shin or foot, and participants need to have at least one open blood vessel in the lower leg.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transverse tibial bone transport (TTT) in addition to standard wound care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including wound healing and vascular changes
What Are the Treatments Tested in This Trial?
Interventions
- Transverse Tibial Bone Transport
Trial Overview
The study is testing a procedure called transverse tibial bone transport using the Biodynamik XT3 device to see if it helps heal stubborn diabetic leg and foot wounds and prevents amputation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Standard Wound Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biodynamik, Inc
Lead Sponsor
Mayo Clinic
Collaborator
Citations
Effectiveness of transverse tibial bone transport in ...
TTT operation was associated with high healing rate and limb salvage rate, and could significantly improve the ABI, skin temperature, and VAS after operation.
Effectiveness of transverse tibial bone transport in ...
In our results, the healing rate and limb salvage rate were demonstrated to be as high as 96% and 98% at final follow-up, and significant improvements on ABI ( ...
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2025/12050/management_of_severe_diabetic_foot_using_modified.120.aspxManagement of severe diabetic foot using modified...
The overall complication rate was 10.42%, and 79.17% of patients showed improved vascularization. Modified transverse tibial bone transport may ...
Comparison of clinical efficacy between tibial cortex ... - PMC
A clinical study involving 136 patients with severe DFUs demonstrated that after two years of follow-up, the wound healing rate reached 96%, ...
The long-term clinical efficacy of transverse tibial bone ...
Results : A total of 51 patients (52 with affected feet) were followed up, and the recovery rate was 67.3%. Among them, the recovery rates at 4, 5, and 6 years ...
A Systematic Review on Tibial Cortex Transverse Transport in ...
Efficacy and safety of unilateral tibial cortex transverse transport on bilateral diabetic foot ulcers: a propensity score matching study. J ...
7.
journals.plos.org
journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0277269Efficacy and safety of tibial cortex transverse transport for ...
The global prevalence of DF is 6.3%, and about 25% of diabetic patients will develop foot ulcers [4]. DF is a complex surgical problem because ...
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