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In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).
Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revascularization | Procedure | Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement) |
| Measure | Description | Time Frame |
|---|---|---|
| Transcutaneous oxygen pressure | Change in transcutaneous oxygen pressure is measured before and after the revascularization procedure. | Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| WIfI stage | Change in WIfI (wound, ischemia, foot infection) stage is documented before and after the revascularization procedure. | Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure |
| Rutherford category |
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Inclusion Criteria:
- patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization.
Exclusion Criteria:
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Patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization procedures (open surgery and/or angioplasty).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian K Enzmann, MD, PhD | Contact | 004343512504 | 82196 | florian.enzmann@i-med.ac.at |
| Michaela Kluckner, MD | Contact | 004343512504 | 83496 | michaela.kluckner@i-med.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, Medical University Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29579461 | Background | Halliday A, Bax JJ. The 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in Collaboration With the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):301-302. doi: 10.1016/j.ejvs.2018.03.004. No abstract available. | |
| 31182334 | Background |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Change in Rutherford category is documented before and after the revascularization procedure.
| Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure |
| Primary patency | Primary patency of the treated arterial lesion is documented after the procedure | Post-procedural (within 5 days) and 3 months after the index procedure |
| Secondary patency | Secondary patency of the treated arterial lesion is documented after the procedure | Post-procedural (within 5 days) and 3 months after the index procedure |
| Limb salvage | Limb salvage of the treated extremity is documented after the procedure | Post-procedural (within 5 days) and 3 months after the index procedure |
| Ankle-brachial index (ABI) | Change in ABI is documented before and after the revascularization procedure. | Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure |
| Fluorescence angiography | Change in fluorescence angiography is documented before and after the revascularization procedure. | Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure |
| Survival | Survival of patients after the revascularization. | Post-procedural (within 5 days) and 3 months after the index procedure |
| Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. |
| 9308598 | Background | Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |