Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry

NCT07014072 | Not Yet Recruiting

• 2 other identifiers: CHUBX 2025/0062025-A00272-47
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal artery revascularization in CLTI, our prospective registry aims to tackle the critical question of whether intensive toe pressure evaluation, guiding repeat revascularization using predetermined thresholds (\<30 mmHg or decrease \>10% from immediate postoperative assessment), could optimize outcomes in patients with CLTI.

Conditions

Critical Limb Ischemia (CLI)

Keywords

CLTI; toe pressure; limb salvage; endovascular revascularization; theatening

Outcome Measures

Primary Outcomes (1)

• Toe pressure with Systolic pressure measurement device

  The Systolic pressure measurement device is suitable for the toes, as part of the diagnosis or monitoring of obliterating arteriopathy of the lower limbs, as for the fingers of the hand during assessments relating to arteriovenous fistulas. The Systolic pressure measurement device ingeniously uses photoplethysmography (PPG) associated with a unique algorithm developed and patented by Atys Medical. PPG makes it possible to detect, thanks to a photoelectric cell (sensor), variations in blood flow in skin traffic. The Systolic pressure measurement deviceputs the measurement of digital pressure pressure within the reach of all the stakeholders concerned (angiologists, nephrologists, diabetologists, vascular surgeons, wound and healing services, etc.).

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Secondary Outcomes (6)

• Evaluation of Survival

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Evaluation of the absence of target lesion occlusion.

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Evaluation of target lesion revascularization

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Evaluation of major adverse limb events

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Evaluation ofthe Wound healing with WiFi classification

  Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Study Arms (2)

Historical cohort

SHAM COMPARATOR

100 patients with CLTI treated in the past 3 years at the same center. Patients in this cohort were treated according to standard clinical practices at the time, without intensive toe pressure evaluation to guide reinterventions, and with reinterventions guided solely by clinical criteria.

Other: data collection

Prospective cohort

EXPERIMENTAL

100 patients included prospectively and treated as part of the study. Patients in this cohort will be followed with an intensive toe pressure evaluation approach (TcPO2), guiding reinterventions according to predetermined thresholds (\<30 mmHg or decrease \>10% from immediate postoperative assessment). This cohort will receive best medical treatment:

Procedure: intensive toe pressure evaluation

Interventions

intensive toe pressure evaluation PROCEDURE

This measurement is non-invasive, painless and is also carried out as part of the care in the follow-up of critical limb ischemia. It takes place like a blood pressure measurement except that it is carried out at the level of a toe.

Prospective cohort

data collection OTHER

retrospective data

Historical cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Rutherford category 4 or 5
• Wounds limited to toes or forefoot with a salvageable limb
• Infrapopliteal lesions (infra-popliteal arteries) with \>70% stenosis upon visual assessment during initial angiography

You may not qualify if:

• Previous or planned major amputation of the target limb
• Untreated aortoiliac/femoropopliteal stenotic disease limiting flow
• History of infrapopliteal bypass on the target limb
• Failure of percutaneous transluminal angioplasty of the target limb (technical failure)
• Absence of angiographic evidence of a patent artery below the ankle ("desert foot")
• Lesions located inside or near an arterial aneurysm
• Life expectancy \< 1 year
• Acute limb ischemia
• Septicemia or bacteremia

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric DUCASSE, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric DUCASSE, MD, PhD

CONTACT

+335 56 79 55 25; eric.ducasse@chu-bordeaux.fr

Olivier Delorme

CONTACT

+335 57 82 01 34; olivier.delorme@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 10, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FR (1)