Foot Perfusion Analysis to Predict Limb Salvage

Peripheral Arterial Disease Clinical Trial

— DELTA-PERF  

Official title:

Perfusion Analysis of the Foot in Patients With Critical Limb Ischemia Before and After Revascularization and Predictive Value on Amputation-free Survival

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03810469
• Other study ID #: 2018-01
• Status: Active, not recruiting
• Start date: February 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2021
• Source: Centre Hospitalier de Valenciennes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 69
• Est. completion date: February 1, 2022
• Est. primary completion date: October 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
France	CH Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valenciennes

Country where clinical trial is conducted

France, 

References & 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. Review. — View Citation

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 — View Citation

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. Re — View Citation

Wickström 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 Dis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Wound Healing	Complete wound Healing at the level of the foot according to the WiFI classification	1 month
Secondary	Wound Healing	Complete wound Healing at the level of the foot according to the WiFI classification	3 months
Secondary	Wound Healing	Complete wound Healing at the level of the foot according to the WiFI classification	6 months
Secondary	Wound Healing	Complete wound Healing at the level of the foot according to the WiFI classification	1 year
Secondary	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)	1 year
Secondary	Overall Mortality	Overall Mortality, all-cause included	1 year