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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: Vein bypass surgery first strategy; Procedure: Endovascular treatment first (drug coated balloon angioplasty) strategy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viktoras Šliaužys, M.D.; Phone Number: +37064297161; Email: viktoras.sliauzys@lsmuni.lt
• Study Contact Backup: Name: Džilda Veličkienė, Prof; Email: dzilda.velickiene@lsmuni.lt

Study Locations

• Lithuania
  • LT
    • Kaunas, LT, Lithuania, 50161
      • Recruiting
      • Lithuanian University of Health Sciences
      • Contact: Vaiva Lesauskaitė, Prof; Phone Number: (8 37) 32 72 06; Email: vaiva.lesauskaite@lsmuni.lt
      • Principal Investigator: Viktoras Šliaužys
      • Sub-Investigator: Džilda Veličkienė, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vein bypass surgery first strategy	Procedure: Vein bypass surgery first strategy; 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.
Active Comparator: Endovascular treatment first (drug coated balloon angioplasty) strategy	Procedure: Endovascular treatment first (drug coated balloon angioplasty) strategy; Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary, primary-assisted and secondary patency	Clinical and ultrasound assesment	24 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: VS3005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No