Chronic Ulcers of the Lower Limb, Diabetic Foot Ulcer
Conditions
Keywords
Transverse Bone Transport, DFU, TTT, Biodynamik, XT3
Brief 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.
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.
Interventions
DEVICEBiodynamik XT3
Application of XT3 system and transverse tibial bone transport procedure
Sponsors
Biodynamik, Inc
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with wound closure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with PAR of greater than 60% at 8 and 18 weeks. | At 8 and 18 weeks | The proportion of patients between each cohort who achieve a Percent Area Reduction of greater than 60% |
| Mean PAR summarized at 8 and 18 weeks | From enrollment to 18 weeks | To compare mean Percent Area Reduction (PAR) between treatment groups at 8 and 18 weeks |
| Frequency of subsequent procedures | From enrollment to 18 weeks | Frequency of subsequent procedures (surgical debridement; minor/major amputation) |
| Time to achieve wound closure | Enrollment through 18 weeks and 12 months | Compare the time to achieve wound closure at 18 weeks and through 12 months |
| Vascular changes as measured by Ankle Brachial Index (ABI) | From enrollment to 18 weeks, 6, 9 and 12 months | ABI (No units; ratio) at 18 weeks and at 6, 9 and 12 months |
| Improvement in Visual Analog Scale to measure pain | From enrollment to 18 weeks | 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). |
| Frequency of wound recurrence | Enrollment until 12 months | Frequency of wound recurrence/re-ulceration at 12 weeks and at 6, 9 and 12 months |
| Amputation free survival | Enrollment until 12 months | Amputation free survival at 12 weeks and at 6, 9 and 12 months |
| Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2) | Measured at baseline to 18 weeks and through 12 months | 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. |
| Improvement in Patient Reported Outcome Wound-QoL-17 at 18 weeks | From enrollment to 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 |
| Time to heal for surgical site | Enrollment to 18 weeks | Time to heal for pin sites, incision sites and bone consolidation |
Countries
United States
Contacts
CONTACTElizabeth Wellings, MD
CONTACTLauren Evans
PRINCIPAL_INVESTIGATORElizabeth Wellings
Mayo Clinic
Outcome results
None listed