Transverse Tibial Bone Transport for Diabetic Foot Ulcers

LE
EW
Overseen ByElizabeth Wellings, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

EW

Elizabeth Wellings

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 22 years old or older.
* Wound stages: WiFi \>= 3
I have at least one open blood vessel in my lower leg.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transverse tibial bone transport (TTT) in addition to standard wound care

18 weeks
Regular visits for monitoring and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing and vascular changes

12 months
Follow-up visits at 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Transverse Tibial Bone Transport

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard Wound Care plus TTTExperimental Treatment1 Intervention
Group II: Standard of Care (control)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biodynamik, Inc

Lead Sponsor

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+