Clinical trial NCT04760119: Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
Official title: Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment will consist of two treatment modalities: 1) Vein bypass surgery first strategy; 2) Endovascular treatment first (drug coated balloon angioplasty) strategy
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient with type 2 diabetes mellitus
* Severe limb ischemia (Rutherford class \>=4) due to infrapopliteal, +/- popliteal disease \[ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; \>40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.\]

Exclusion Criteria:

* Requires primary limb amputation
* Acute limb ischemia
* Anticipated life expectancy of \<2 years
* Unsuitable for either revascularisation strategy
* Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)

Primary outcomes:
measure: Primary, primary-assisted and secondary patency
timeFrame: 24 months
Secondary outcomes:
measure: Ischemic symptoms
timeFrame: 24 months
measure: Ankle-brachial index (ABI)
timeFrame: 24 months
measure: Toe-brachial index (TBI)
timeFrame: 24 months
measure: Transcutaneous oxygen tension (TcPO2)
timeFrame: 24 months
measure: Healing of tissue loss (ulcers, gangrene)
timeFrame: 24 months
measure: Re- and cross-over intervention rates
timeFrame: 24 months
measure: Major and minor amputation rates
timeFrame: 24 months
measure: In-hospital morbidity/mortality and overall survival
timeFrame: 24 months
measure: Relief of pain: Visual analog scale (VAS)
timeFrame: 24 months
measure: Quality of life: EQ-5D-5L questionaire
timeFrame: 24 months
measure: Diabetic neuropathy dinamics: clinical examination of foot sensation
timeFrame: 24 months
measure: Diabetic neuropathy dinamics: neurometer
timeFrame: 24 months
measure: Diabetic neuropathy dinamics: electroneuromiography
timeFrame: 24 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
state: LT
Study officials:
References: