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The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.
Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN).
All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered.
To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial.
If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission
Patient will be randomised to one of the following groups:
A. Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy
Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vein bypass surgery first strategy | Active Comparator |
| |
| Endovascular treatment first (drug coated balloon angioplasty) strategy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vein bypass surgery first strategy | Procedure | Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary, primary-assisted and secondary patency | Clinical and ultrasound assesment | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic symptoms | Fontaine classification: I asymptomatic; IIa mild claudication; IIb moderate-to-severe claudication; III rest pain; IV ulceration or gangrene. Rutherford classification: 0 asymptomatic; 1 mild claudication; 2 moderate claudication; 3 severe claudication; 4 rest pain; 5 minor tissue loss; 6 severe tissue loss or gangrene. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktoras Šliaužys, M.D. | Contact | +37064297161 | viktoras.sliauzys@lsmuni.lt | |
| Džilda Veličkienė, Prof | Contact | dzilda.velickiene@lsmuni.lt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Recruiting | Kaunas | LT | 50161 | Lithuania |
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The treatment will consist of two treatment modalities: 1) Vein bypass surgery first strategy; 2) Endovascular treatment first (drug coated balloon angioplasty) strategy
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Blinding is not possible due to the completely different natures of the treatments allocated.
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|
| Endovascular treatment first (drug coated balloon angioplasty) strategy | Procedure | Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated. |
|
| Ankle-brachial index (ABI) | Ratio of the blood pressure at the ankle to the blood pressure in the upper arm. Norm 1.0-1.4 | 24 months |
| Toe-brachial index (TBI) | Ratio of the blood pressure of the great toe to the blood pressure in the upper arm. Norm 1.0-1.4 | 24 months |
| Transcutaneous oxygen tension (TcPO2) | A noninvasive test that directly measures the oxygen level of tissue beneath the skin. A TcPO2 greater than 55 mmHg is considered normal regardless of the site of measurement, whereas a value of 40 mmHg is the critical value below which wound healing is impaired and ischemia develops. | 24 months |
| Healing of tissue loss (ulcers, gangrene) | Clinical examination and photo documentation. | 24 months |
| Re- and cross-over intervention rates | 24 months |
| Major and minor amputation rates | 24 months |
| In-hospital morbidity/mortality and overall survival | 24 months |
| Relief of pain: Visual analog scale (VAS) | The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). | 24 months |
| Quality of life: EQ-5D-5L questionaire | Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension. | 24 months |
| Diabetic neuropathy dinamics: clinical examination of foot sensation | Full hypoesthesia; Partial hypoesthesia; No changes; + Assymetry. | 24 months |
| Diabetic neuropathy dinamics: neurometer | Perception threshold measurement. Neurometer® determines three sub-types of nerve fiber by producing transcutaneous electrical stimuli at frequencies of 2000, 250 and 5 Hz. | 24 months |
| Diabetic neuropathy dinamics: electroneuromiography | Diagnostic procedure that evaluates the health condition of muscles and the nerve cells that control them. A nerve conduction velocity between 50 and 60 meters per second is generally considered in the normal range. | 24 months |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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