NCT06966297

Brief Summary

The aim of the proposed study is to analyse the improvement of the calf muscle perfusion of patients with PAD Fontaine stage II and critical limb threatheaning ischemia (CLTI) after endovascular and surgical revascularization procedures using multispectral optoacoustic tomography (MSOT)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

May 2, 2025

Last Update Submit

May 12, 2025

Conditions

PADVascular Diseases

Keywords

PADOptoacoustic Imaging

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography

    1 Hour

Study Arms (4)

PAD Fontaine stage II endo

Patients in PAD Stage II receiving endovascular revascularization procedures

PAD Fontaine stage II open

Patients in PAD Stage II receiving open surgical revascularization procedures

Diagnostic Test: Multispectral optoacoustic tomography

PAD CLTI endo

Patients in PAD-CLTI (Chronic limb threatening ischemia) receiving endovascular revascularization procedures

Diagnostic Test: Multispectral optoacoustic tomography

PAD CLTI open

Patients in PAD PAD-CLTI (Chronic limb threatening ischemia) receiving open surgical revascularization procedures

Diagnostic Test: Multispectral optoacoustic tomography

Interventions

Multispectral optoacoustic tomographyDIAGNOSTIC_TEST

Measurement of calf muscle Perfusion via Multispectral optoacoustic Tomography

PAD CLTI endoPAD CLTI openPAD Fontaine stage II open

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 patients diagnosed with PAD were recruited for the study. Patients were included if they were scheduled for revascularization, either through endovascular therapy or an open surgical procedure.

You may qualify if:

  • Diagnosis of PAD confirmed by clinical examination and ABI (ABI ≤ 0.90)
  • Planned for elective revascularization therapy
  • Able to provide informed consent
  • PAD stages II-IV Fontaine
  • Age of \> 18 years

You may not qualify if:

  • Severe comorbid conditions
  • Non-PAD related walking impairments (e.g., neurological disorders)
  • Inability to comply with study protocols
  • PAD stage I
  • Age of \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (5)

  • Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.

    PMID: 28938901BACKGROUND

  • Lawall, H., P. Huppert, and G. Rümenapf. "S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der peripheren arteriellen Verschlusskrankheit." Deutsche Gesellschaft für Angiologie und Deutsche Gesellschaft für Gefäßmedizin 30 (2015).

    BACKGROUND

  • Lanzer, P. (2018). Primary media sclerosis Mönckeberg: Diagnostic criteria. Cor et Vasa, 60(2), e205-e208.

    BACKGROUND

  • Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.

    PMID: 4885945BACKGROUND

  • Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.

    PMID: 33553329BACKGROUND

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

March 1, 2024

Primary Completion

February 10, 2025

Study Completion

March 1, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)