Critical Limb IschemiaDELTA-PERFNCT03810469
Foot Perfusion Analysis to Predict Limb Salvage
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Arterial Disease
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 4 Apr 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion Analysis of the Foot in Patients With Critical Limb Ischemia Before and After Revascularization and Predictive Value on Amputation-free Survival
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.
Read the detailed description
Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is already recognized as a major health issue. CLI is frequently leading to major amputations. Therefore, one of the key point to prevent limb loss is to restore a good vascularization to the foot, usually thanks to endovascular means.
No consensual indicator is currently available to estimate if the limb revascularization will be sufficient or not to prevent amputation, and to help physicians decide if they should be more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the ankle-brachial index (ABI) are commonly used in the ward (not available in the operating room), but have shown poor correlation to wound healing or limb salvage and results are frequently biased because of the arterial wall calcifications due to diabetes. Value of the first toe systolic pressure is currently under evaluation to predict survival without amputation, with promising results, but cannot be applied to patients with wounds at this level or previous minor amputation.
The emergence of hybrid rooms in the operating theater offer access to high quality imaging and image post-treatment. Those capabilities could be used to analyze the flow and the tissue perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes, such as wound healing, thus creating a useful tool to guide physicians in daily practice.
Differences between foot angiographies performed before and after revascularization could be used to estimate the quality of the revascularization and predict wound healing and limb salvage. This method would be directly available in the operating room and could help physicians to optimize their strategy during the procedure
- Keywords
- limb salvage, foot perfusion, hybrid room
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 year
Secondary outcomes (6)
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Measured: 1 month
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Measured: 3 months
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Measured: 6 months
Wound Healing
Complete wound Healing at the level of the foot according to the WiFI classification
Measured: 1 year
Number of patients with secondary intervention
Number of participants with a secondary intervention. Secondary intervention is defined as all secondary surgical interventions (both endovascular and open repairs) associated to critical limb ischemia on the same limb. It includes secondary angioplasties, bypasses or minor and major amputations. This is a clinical binary criterion (0= Freedom from secondary intervention, 1=At least one secondary intervention)
Measured: 1 year
Overall Mortality
Overall Mortality, all-cause included
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Feb 2019
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Why it stopped: COVID-19 disrupted recruitment and follow-up in 2020. Following the investigators' departure, recruitment could not resume, leading to premature study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810469
- Sponsor's protocol ID
- 2018-01
- Acronym
- DELTA-PERF
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23540807Wang 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.
PubMed 26804365Wickstrom 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.
PubMed 28292565Brownrigg 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.
PubMed 26342129
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Analysis of the Foot in Patients With Critical Limb Ischemia Before and After Revascularization and Predictive Value on Amputation-free Survival
- ClinicalTrials.gov ID
- NCT03810469
- Acronym / sponsor ID
- DELTA-PERF / 2018-01
- Keywords
- limb salvage, foot perfusion, hybrid room
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 disrupted recruitment and follow-up in 2020. Following the investigators' departure, recruitment could not resume, leading to premature study termination.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Critical limb ischemia (CLI) in diabetic patients is increasing drastically worldwide, and is already recognized as a major health issue. CLI is frequently leading to major amputations. Therefore, one of the key point to prevent limb loss is to restore a good vascularization to the foot, usually thanks to endovascular means.
No consensual indicator is currently available to estimate if the limb revascularization will be sufficient or not to prevent amputation, and to help physicians decide if they should be more aggressive during the endovascular procedure. Transcutaneous oximetry and value of the ankle-brachial index (ABI) are commonly used in the ward (not available in the operating room), but have shown poor correlation to wound healing or limb salvage and results are frequently biased because of the arterial wall calcifications due to diabetes. Value of the first toe systolic pressure is currently under evaluation to predict survival without amputation, with promising results, but cannot be applied to patients with wounds at this level or previous minor amputation.
The emergence of hybrid rooms in the operating theater offer access to high quality imaging and image post-treatment. Those capabilities could be used to analyze the flow and the tissue perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes, such as wound healing, thus creating a useful tool to guide physicians in daily practice.
Differences between foot angiographies performed before and after revascularization could be used to estimate the quality of the revascularization and predict wound healing and limb salvage. This method would be directly available in the operating room and could help physicians to optimize their strategy during the procedure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with major amputation
Time frame: 1 month
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)
Number of participants with major amputation
Time frame: 3 months
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)
Number of participants with major amputation
Time frame: 6 months
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)
Number of participants with major amputation
Time frame: 1 year
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 secondary outcomes
Wound Healing
Time frame: 1 month
Wound Healing
Time frame: 3 months
Wound Healing
Time frame: 6 months
Wound Healing
Time frame: 1 year
Number of patients with secondary intervention
Time frame: 1 year
Overall Mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: COVID-19 disrupted recruitment and follow-up in 2020. Following the investigators' departure, recruitment could not resume, leading to premature study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 23540807Brownrigg 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.
- Results publication: PubMed 26804365Wang 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.
- Results publication: PubMed 28292565Wickstrom 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.
- Results publication: PubMed 26342129Brownrigg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia and Peripheral Arterial Disease, run by Centre Hospitalier de Valenciennes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 disrupted recruitment and follow-up in 2020. Following the investigators' departure, recruitment could not resume, leading to premature study termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with major amputation (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810469, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.