NCT03810469

Brief Summary

This study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

January 15, 2019

Last Update Submit

April 23, 2021

Conditions

Critical Limb IschemiaPeripheral Arterial Disease

Keywords

limb salvagefoot perfusionhybrid room

Outcome Measures

Primary Outcomes (4)

  • Number of participants with major amputation

    Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)

    1 month

  • Number of participants with major amputation

    Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)

    3 months

  • Number of participants with major amputation

    Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)

    6 months

  • Number of participants with major amputation

    Major amputations are defined as below or above the knee amputations on the treated limb. This is a clinical binary criterion (0=Freedom from major amputation, 1=Major amputation)

    1 year

Secondary Outcomes (6)

  • Wound Healing

    1 month

  • Wound Healing

    3 months

  • Wound Healing

    6 months

  • Wound Healing

    1 year

  • Number of patients with secondary intervention

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

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

Patients suffering from peripheral arterial disease in critical limb ischemia (Rutherford 4, 5 and 6) at the initial presentation, with a major risk of limb amputation at mid-term without revascularization.

You may qualify if:

  • Patients with critical limb ischemia Rutherford 4, 5 and 6, with at least one pre-operative exam (CTA, magnetic resonance angiography or ultrasound) demonstrating a peripheral arterial disease, and requiring an endovascular or hybrid (meaning combined with a surgical technique) revascularization of the lower limb.

You may not qualify if:

  • Patients not willing to give their consent to study enrollment
  • Patients under 18 years old
  • Patients with severe renal insufficiency (estimated creatinine clearance \< 30 mL/min), without dialysis
  • Patients with life threatening septic wounds who would require an amputation at the initial presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Valenciennes

Valenciennes, 59322, France

Location

Related Publications (4)

  • Brownrigg JR, Apelqvist J, Bakker K, Schaper NC, Hinchliffe RJ. Evidence-based management of PAD & the diabetic foot. Eur J Vasc Endovasc Surg. 2013 Jun;45(6):673-81. doi: 10.1016/j.ejvs.2013.02.014. Epub 2013 Mar 27.

    PMID: 23540807RESULT

  • Wang Z, Hasan R, Firwana B, Elraiyah T, Tsapas A, Prokop L, Mills JL Sr, Murad MH. A systematic review and meta-analysis of tests to predict wound healing in diabetic foot. J Vasc Surg. 2016 Feb;63(2 Suppl):29S-36S.e1-2. doi: 10.1016/j.jvs.2015.10.004.

    PMID: 26804365RESULT

  • Wickstrom JE, Laivuori M, Aro E, Sund RT, Hautero O, Venermo M, Jalkanen J, Hakovirta H. Toe Pressure and Toe Brachial Index are Predictive of Cardiovascular Mortality, Overall Mortality, and Amputation Free Survival in Patients with Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 May;53(5):696-703. doi: 10.1016/j.ejvs.2017.02.012. Epub 2017 Mar 11.

    PMID: 28292565RESULT

  • Brownrigg JR, Hinchliffe RJ, Apelqvist J, Boyko EJ, Fitridge R, Mills JL, Reekers J, Shearman CP, Zierler RE, Schaper NC; International Working Group on the Diabetic Foot. Performance of prognostic markers in the prediction of wound healing or amputation among patients with foot ulcers in diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:128-35. doi: 10.1002/dmrr.2704.

    PMID: 26342129RESULT

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 18, 2019

Study Start

February 1, 2019

Primary Completion

October 2, 2021

Study Completion

February 1, 2022

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

FR(1)