Health TrialsbyHealthPanel

Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds

ConditionsDiabetic Foot UlcerChronic Ulcers of the Lower Limb
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBiodynamik, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biodynamik XT3

    Device

    Application of XT3 system and transverse tibial bone transport procedure

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard of Care (control)No intervention 0 interventions
Group B: Standard Wound Care plus TTTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 18 weeks

Secondary outcomes

1

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%

Time frame
At 8 and 18 weeks
2

Mean PAR summarized at 8 and 18 weeks

To compare mean Percent Area Reduction (PAR) between treatment groups at 8 and 18 weeks

Time frame
From enrollment to 18 weeks
3

Frequency of subsequent procedures

Frequency of subsequent procedures (surgical debridement; minor/major amputation)

Time frame
From enrollment to 18 weeks
4

Time to achieve wound closure

Compare the time to achieve wound closure at 18 weeks and through 12 months

Time frame
Enrollment through 18 weeks and 12 months

Other outcomes

1

Safety Endpoint - Adverse Events

• Frequency of treatment-emergent serious and non-serious adverse events

Time frame
Enrollment to 18 weeks
2

Safety endpoint - TTT Related

Frequency of device-related adverse events in the TTT arm including pin site infection and device breakage

Time frame
Enrollment to 18 weeks
3

Plasma growth factor level changes as measured by VEGf at 18 weeks and at 6,9 and 12 months

Vascular Endothelial Growth Factor) measured in either picograms per milliliter (pg/mL) or nanograms per liter (ng/L) in serum or plasma

Time frame
From enrollment until 12 months
4

Vascular Perfusion measured by Computed Tomography Angiogram (CTA) at 18 weeks and at 6, 9 and 12 months

CTA is measured in Hounsfield Units (HU)

Time frame
Through 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biodynamik, Inc

Lead sponsor

Mayo Clinic

Collaborator

Source ClinicalTrials.gov
Apply now