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

Not Applicable

• Conditions: Critical Limb Ischemia

• Registration Number: NCT04760119
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2021-01-22
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary, primary-assisted and secondary patency	24 months	Clinical and ultrasound assesment

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial index (ABI)	24 months	Ratio of the blood pressure at the ankle to the blood pressure in the upper arm. Norm 1.0-1.4
Toe-brachial index (TBI)	24 months	Ratio of the blood pressure of the great toe to the blood pressure in the upper arm. Norm 1.0-1.4
Transcutaneous oxygen tension (TcPO2)	24 months	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.
Healing of tissue loss (ulcers, gangrene)	24 months	Clinical examination and photo documentation.
Re- and cross-over intervention rates	24 months
Ischemic symptoms	24 months	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.
In-hospital morbidity/mortality and overall survival	24 months
Diabetic neuropathy dinamics: clinical examination of foot sensation	24 months	Full hypoesthesia; Partial hypoesthesia; No changes; + Assymetry.
Diabetic neuropathy dinamics: neurometer	24 months	Perception threshold measurement. Neurometer® determines three sub-types of nerve fiber by producing transcutaneous electrical stimuli at frequencies of 2000, 250 and 5 Hz.
Diabetic neuropathy dinamics: electroneuromiography	24 months	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.
Major and minor amputation rates	24 months
Relief of pain: Visual analog scale (VAS)	24 months	The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
Quality of life: EQ-5D-5L questionaire	24 months	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.

Trial Locations

Locations (1)

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, LT, Lithuania