Complete Ulcer Healing as Primary Endpoint in Studies on Critical Limb Ischemia? A Critical Reappraisal

Hoffmann, Ulrich; Schulte, K.-L.; Heidrich, H; Rieger, H.; Schellong, Sebastian

doi:10.1016/j.ejvs.2006.10.003

Cited by 26 publications

(14 citation statements)

References 20 publications

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“…To the best of our knowledge, this study represents the largest study evaluating the influence of revascularization based on the angiosome concept in the healing of foot ulcers. 14,23,30,31 The results of this study indicate that providing direct blood flow to the specific area of a diabetic foot ulcer has a favorable effect on ulcer healing and should be preferred to indirect revascularization. One reason for the superiority of direct revascularization in this study might be that the choke vessels in diabetics tend to be compromised.…”

Section: Discussionmentioning

confidence: 79%

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Angiosome-targeted infrapopliteal endovascular revascularization for treatment of diabetic foot ulcers

Söderström

Albäck

Biancari

et al. 2013

Journal of Vascular Surgery

125

166

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Section: Discussionmentioning

confidence: 79%

“…13 Ulcer healing time is seldom reported in lower leg revascularization studies. 14 Despite successful revascularization, ulcer healing is a very slow process, especially in diabetics. [15][16][17] There is a need to identify methods that will enhance the healing process of diabetic foot ulcers.…”

mentioning

confidence: 99%

Angiosome-targeted infrapopliteal endovascular revascularization for treatment of diabetic foot ulcers

Söderström

Albäck

Biancari

et al. 2013

Journal of Vascular Surgery

125

166

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“…Improved reimbursement and inclusion of adequately trained physiotherapists on clinical teams managing patients with PAD could help improve outcomes . Complete healing is not an expected outcome for many patients with PAD, so healing endpoints currently required for regulatory clearance in Europe and the United States may be inappropriate for ischaemic leg ulcers …”

Section: Discussionmentioning

confidence: 99%

“…123 Complete healing is not an expected outcome for many patients with PAD, so healing endpoints currently required for regulatory clearance in Europe and the United States may be inappropriate for ischaemic leg ulcers. 21,124 Strong evidence supported improved walking capacity, pain, and QOL parameters in patients with PAD managed with either SET or ER, especially so if combined or administered to those with less severe PAD. This pattern was paralleled by studies using NMES and IPC interventions, which may represent opportunities for calf muscle activity stimulation between scheduled SET interventions.…”

Section: Implications For Practicementioning

confidence: 99%

Peripheral arterial disease: Scoping review of patient‐centred outcomes

Bolton

2019

International Wound Journal

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Peripheral arterial disease (PAD) impairs patients' quality of life (QOL), walking and ulcer healing, increasing patient pain, costs, and risks of amputation or mortality. A literature appraisal described PAD treatment capacity to improve validated patient-centred outcomes in controlled clinical studies. The PUBMED database was searched from 1 January 1970 to 21 June 2018, for original and derivative controlled clinical trial references addressing MeSH terms for 'ischemia' AND 'leg ulcer'. Non-ischemic ulcer treatment references were excluded. Frequencies of improved (P < .05) outcomes were reported. Eighty-eight studies on 4153 patients were summarized. Walking, pain or QOL improved mainly for interventions administered before PAD became severe. Amputation incidence, pain and ulcer healing were more frequently reported in those with severe PAD. Independent of PAD severity, patients experienced more likely improved walking, QOL, or pain reduction in response to structured walking interventions or those increasing calf muscle activity. Those with more severe PAD were more likely to report amputation reduction, mainly in response to invasive interventions. Those with PAD experienced more consistently improved patient-centred outcomes if they received multidisciplinary PAD management with supervised walking or calf muscle activity, with more likely amputation risk reduced for those with more severe PAD. Key Messages• Peripheral arterial disease (PAD) progresses in severity from impaired walking and quality of life (QOL) through increasing likelihood of pain, ulceration, gangrene, amputation, or death and magnifies clinical, economic, and patient burdens of venous insufficiency or diabetes • improving PAD-related patient-centred outcomes requires consistent early, effective PAD diagnosis and effective treatment to improve lower limb perfusionAbbreviations: ABI, ankle-to-brachial systolic blood pressure index (ratio), optimally performed using handheld Doppler ultrasound; ALU, arterial leg ulcers; CLI, critical limb ischaemia; DAPT, dual antiplatelet therapy, for example, aspirin plus low molecular weight heparin; DFU, diabetic foot ulcers; ER, endovascular revascularisation; HBO, hyperbaric oxygen; IC, intermittent claudication; IPC, intermittent pneumatic compression of the calf muscle; MLU, mixed aetiology leg ulcers complicated with peripheral arterial disease; NMES, neuromuscular electrical stimulation sufficient to cause contraction of the calf muscle; PAD, peripheral arterial disease; PPG, photoplethysmography a technique for measuring venous emptying; QOL, quality of life; RCT, randomised clinical trial; SET, structured exercise therapy supervised by a professional; SOC, standard of care; TcPO 2 , transcutaneous partial pressure of oxygen; VLU, venous leg ulcer.

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“…Outcomes remain the ultimate measure of success; however, debate exists as to what is the most appropriate end point. 6 In studies involving CLI patients, limb salvage or amputation-free survival is the most frequent end point. In the interest of establishing the durable effects of tibial interventional techniques, vessel patency likely should be assessed and, in fact, may be required to prove efficacy of any particular device, if the goal is to achieve an FDA approval of that device for a BTK indication.…”

Section: Datamentioning

confidence: 99%

Tibial Intervention for Critical Limb Ischemia

Wiechmann¹

2009

Semin intervent Radiol

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Diagnosis and treatment of critical limb ischemia (CLI) is increasingly important as the average age of the world population and the incidence of diabetes and metabolic syndrome increases. Fortunately, most patients will not progress to this stage of peripheral arterial disease, yet if left untreated, there is a high risk of future cardiovascular events. At the point of ischemic rest pain or tissue loss, there are significant implications for morbidity and mortality. There is a high prevalence of multisegment occlusive disease in the CLI patient with the infrapopliteal vessels frequently involved. Revascularization of the affected limb is of utmost importance as the prospects of wound healing and relief of ischemic rest pain are poor without reestablishing continuous flow to the distal extremity. With the advent of endovascular devices designed to treat this vexing problem, the ability to successfully treat this difficult patient population with less procedural morbidity has been greatly enhanced.

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Complete Ulcer Healing as Primary Endpoint in Studies on Critical Limb Ischemia? A Critical Reappraisal

Abstract: In past and current literature, complete ulcer healing is not a consistently reported criterion for success of revascularization in CLI. Thus, its appropriateness for efficacy assessment of drug studies in CLI patients has to be questioned.

Cited by 26 publications

References 20 publications

Angiosome-targeted infrapopliteal endovascular revascularization for treatment of diabetic foot ulcers

Angiosome-targeted infrapopliteal endovascular revascularization for treatment of diabetic foot ulcers

Peripheral arterial disease: Scoping review of patient‐centred outcomes

Tibial Intervention for Critical Limb Ischemia

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