Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry).

PURPOSE: This study reports the outcomes from a Multicenter Registry on unibody stent-graft system for the treatment of spontaneous infrarenal acute aortic syndrome (MURUSSIAS registry). MATERIALS AND METHODS: The retrospective MURUSSIAS registry included spontaneous infrarenal acute aortic dissection (IAAS) managed with the unibody stent-graft system (AFX endovascular AAA system; Endologix Inc., Irvine, California) outside the current instruction for use. IAAS considered aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Indications to IAAS treatment were symptoms, associated dilated abdominal aorta (>3 cm), rapidly-growing (>0.5 cm/6 months) aorta, IAAS disease progression. Measured results were technical success, early (within 30 days) and midterm outcomes (after 30 days), including mortality, complications, symptoms recurrence, type I/III endoleak occurrence, stent-graft patency, survival, and freedom from reintervention. The mean follow-up was 22.12 ± 17 months. RESULTS: The MURUSSIAS registry included 83 patients from 7 participating centers. IAAS indication to treatment were symptoms in 42 (51%). In 14 (17%) patients, the infrarenal aortic length was <80 mm, and in 28 (34%), the aortic bifurcation diameter was <16 mm. Technical success was 100%. Mortality occurred early in 1 (1%) and at the midterm in 3 (4%) patients. Complications occurred early in 10 (12%) patients (1 severe, 3 moderates, and 6 mild) and at midterm in 2 (2%) (2 moderate). No symptoms' recurrence or type I/III endoleaks were registered. The 36-month estimated survival and freedom from reinterventions were 89% and 92%, respectively. CONCLUSIONS: The MURUSSIAS registry is the largest collection of spontaneous IAAS managed endovascularly using the AFX endovascular AAA system. The IAAS peculiar anatomic features were fitted with the used technique with excellent results. This treatment strategy might be considered in IAAS unless specifically-designed endovascular solutions will be available also in the emergent setting. Further studies are required to assess the longer-term performances and the stability of the reported technique. CLINICAL IMPACT: The lack of specifically designed devices for infrarenal acute aortic syndrome (IAAS) disease remains an issue principally for its specific anatomic features. The MURUSSIAS registry retrospectively examined the outcomes of spontaneous IAAS treated using the unibody stent-graft system in a spontaneous national study; and reports the largest available data on this topic. The use of the unibody stent-graft system showed to fit the anatomic peculiarities of IAAS with excellent outcomes. This IAAS treatment strategy should be considered unless specifically designed endovascular solutions will be available.

Stent-Graft Relining Using the Altura Endograft for Type Ia and IIIb Endoleaks after Kissing Iliac Arteries Stent.

A 79 years old man, affected by serious comorbidities, occurred to the Emergency Room of our Hospital complaining abdominal pain. He was previously submitted to kissing iliac arteries stent for iliac aneurysms. An urgent CT scan showed a type Ia and a type IIIb endoleaks with left common iliac artery enlargement, occlusion of both hypogastric arteries and inferior mesenteric artery, and a severe stenosis of the right iliac external artery. We opted for a relining with a two-piece D-shaped Altura endograft for the aorta, with bilateral iliac components, landing at the level of the external iliac arteries. Postoperative course was uneventful with no endoleak or endograft migration on CT scan control at 6 months.

Endovascular Treatment of Juxtarenal Abdominal Aortic Aneurysms Recurring to the "Vent Technique".

BACKGROUND: Juxtarenal abdominal aortic aneurysms represent 15-20% of all abdominal aortic aneurysms (AAAs). The gold standard of treatment is represented by open surgical repair (OSR). Patients judged unfit for OSR could be submitted to fenestrated endovascular aortic repair (FEVAR) or the chimney technique. FEVAR requires 3-4 weeks for endograft production, a minimal length of 4 mm for proximal aortic neck and a large access vessels diameter, with high costs. The traditional chimney technique, feasible also in urgent cases, has a risk of type IA endoleak due to the space created between covered stents introduced into visceral arteries and the endograft. METHODS: In the present article, we report our experience about juxtarenal AAA (jAAA) treatment in 5 patients, recurring to uncovered bare metal stents associated with the ultralow profile Ovation endograft. RESULTS: No intraoperative complications or type IA endoleaks were recorded. Primary clinical success at 1 month was also 100%. During a mean follow-up period of 12.1 ± 3.6 months (range, 9-15 months), no complications related to aneurysm were recorded. CONCLUSIONS: The technique reported represents a valid endovascular option for jAAA treatment in patients at high risk for OSR. With respect to FEVAR, urgent patients should also be treated. With respect to traditional Ch-EVAR, the risk of type IA endoleak is reduced, with a lower rate of reoperation during follow-up. Preliminary clinical results are promising.

Successfully Kissing Stent of Innominate Artery and Left Common Carotid Artery Subsequent to Blunt Injury, in the Setting of a Bovine Aortic Arch.

Blunt injuries of the great vessels arising from the aortic arch are usually fatal. The innominate artery lesions represent the most common site of injury after the aortic isthmus distal to the left subclavian artery. Injuries are usually located at the origin of the vessel from the aortic arch, especially in patients with bovine aortic arch. Open traditional repair is a successful but invasive treatment, with long hospital stay and different possible complications. Although a bovine aortic arch presents an increased technical challenge, it is possible to achieve a complete and safe repair of the innominate artery injuries through a total endovascular treatment, with important reduction of risks and complications related to operation, compared to traditional open repair. We report the case of a 62-year-old man in our hospital with a posttraumatic pseudoaneurysm of the innominate artery in the setting of a bovine aortic arch, associated with a transection of the descending thoracic aorta. In the urgent setting, the patient was submitted to a kissing stent of innominate artery-left common carotid artery and deployment of thoracic endoprosthesis to exclude the aortic transection, with good final result.

Endovascular Treatment of a Carotid Pseudoaneurysm Using the New Double-Layer Micromesh Stent (Roadsaver®).

Pseudoaneurysm (PA) formation after carotid endarterectomy (CEA) is a very uncommon but dangerous complication, potentially responsible for cerebral embolism or rupture. Therefore, the PA treatment is imperative. Until few years ago, the treatment of choice was represented by open surgical repair, with a higher mortality and morbidity rate than primary operation. Actually, the advancements in endovascular procedures allow the surgeon the possibility to recur to a less invasive approach in the presence of an adequate anatomy, reducing the risk of cranial nerve injuries. We present a case of post-CEA PA successfully treated using the double-layer micromesh stent (Roadsaver®; Terumo, Tokyo, Japan), with almost immediate thrombosis of the aneurysmal sac.

Endovascular Aortic Repair Complications and the Power of Endovascular Solutions.

We report the case of a 75-year-old man submitted to traditional endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm. He presented a late type II endoleak 6 months after operation, initially without sac enlargement. One year later, a computed tomography scan control demonstrated a sac expansion >10 mm, also responsible for a secondary proximal type I endoleak. The patient was submitted to transarterial embolization of lumbar arteries through left internal iliac artery, followed by type I endoleak correction with a proximal cuff deployment. Intraoperative angiography revealed no signs of endoleak. Six months later, a sudden enlargement of the sac was detected, with evidence of type III endoleak, probably consequence of the lumbar arteries embolization, promptly corrected through an aortoaortic endograft. In conclusion, even if a conservative approach for type II endoleak without sac enlargement is proposed, sometimes a sudden sac enlargement could be responsible for catastrophic events in the absence of strict follow-up. The sac embolization during EVAR could reduce the incidence of type II endoleak during follow-up, with reoperation and hospital cost reduction.

Haemorrhage from varicose veins and varicose ulceration: A systematic review.

Varicose veins (VVs) and varicose ulceration (VU) are usually considered non-life-threatening conditions, but in some cases they can lead to major complications such as fatal bleeding. The aim of this systematic review is to evidence the most updated information on bleeding from VV and VU. As evidence acquisition, we planned to include all the studies dealing with "Haemorrhage/Bleeding" and "VVs/VU". We excluded all the studies, which did not properly fit our research question, and with insufficient data. As evidence synthesis, of the 172 records found, after removing of duplicates, and after records excluded in title and abstract, 85 matched our inclusion criteria. After reading the full-text articles, we decided to exclude 68 articles because of the following reasons: (1) not responding properly to our research questions; (2) insufficient data; the final set included 17 articles. From literature searching, we identify the following main issues to be discussed in the review: epidemiology and predisposing factors, pathophysiology and forensic aspects, first aid. It has been estimated that deaths for bleeding due to peripheral venous problems account up to 0.01% of autopsy cases. From a pathological point of view, venous bleeding may arise from either acute or chronic perforation of an enlarged vein segment through the weakened skin. From a forensic point of view, in cases of fatal haemorrhage the death scene can even simulate non-natural events, due to crime or suicide. In most cases, incorrect first aid led to fatal complications. Further investigation on epidemiology and prevention measures are needed.

An Hybrid 2-Stage Technique to Treat a Post-Traumatic Internal Carotid-Jugular Fistula.

Penetrating wounds of the neck involving the carotid arteries can lead to 2 possible and important late sequelae: pseudoaneurysm formation and arteriovenous fistula (AVF), if an artery and the adjacent jugular vein are simultaneously lacerated. Traumatic AVF of the neck are rare complications and if untreated may cause congestive heart failure, cerebral ischemia, thromboembolism, or even rupture complications. Current treatment options for carotid-jugular AVF include operative repair, detachable balloon, coiling, or stenting. We present a hybrid 2-stage technique to treat an internal carotid-jugular vein fistula in a young woman, based first on carotid stenting to reduce the bleeding and reestablish an adequate cerebral perfusion, followed by stent removal and safe vessels surgical reconstruction through carotid-to-carotid bypass and vein repair.

Traumatic Anterior Knee Dislocation with Popliteal Artery Injury: The Importance of a Prompt Diagnosis and Treatment to Obtain Lower Limb Salvage.

We report a case of traumatic anterior dislocation of the left knee in association with disruption of the soft tissues including knee ligaments, popliteal artery, and common peroneal nerve, resulting in lower limb acute ischemia. All components of this complex trauma were recognized and treated promptly. First, he was submitted to closed reduction of the dislocated knee under general anesthesia; right after he underwent superficial femoro-tibioperoneal trunk bypass using a reversed saphenous contralateral vein recurring to a posterior approach through a popliteal S-shaped incision; rehabilitation program was initiated early; a second and final reconstructive orthopedic operation was carried out in a different center. The present case is important in 2 aspects. First, it reports a very rare occurrence of simultaneous anterior dislocation of the knee associated with vascular insult and common peroneal nerve injury, which was rarely reported in the current literature; second, it highlights that with timely intervention and a team approach, excellent results could be achieved.

Preliminary Results of Aorfix™ Stent Graft to Treat Infrarenal Abdominal Aortic Aneurysms with Severe Proximal Aortic Neck Angulation.

BACKGROUND: We report a preliminary experience about endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysm (iAAA) with severe proximal aortic neck angulation (NA) using the Aorfix™ stent graft. METHODS: Data of consecutive patients with iAAA with severe proximal NA submitted to endovascular repair between September 2012 and December 2014 in 2 Italian centers of Vascular and Endovascular Surgery were retrospectively reviewed, and outcomes were analyzed using the software JMP 5.1.2. RESULTS: A total of 26 patients were treated. Median proximal NA was 87.5° (range 68-108°), and 3 patients were treated outside the instruction for use of Aorfix because of a proximal NA > 90°. Eleven patients (42.3%) had severe iliac tortuosity. The primary success rate was 92.3%, as 2 patients required intraoperative correction of a type Ia endoleak. Within 30 days, a right limb occlusion was successfully resolved with endovascular recanalization. The median follow-up period was 14 months (range 1-48 months): 1 patient died for neoplasm and 1 patient presented a type II endoleak from lumbar arteries at 3 months, which is still under surveillance. No other complications were reported during the follow-up period. CONCLUSIONS: Preliminary results with the Aorfix stent graft seemed to be promising in the aim of reducing endoleak and migration rates in presence of iAAA with severe proximal aortic NA.

A Combination of Thoracic and Abdominal Stent-Grafts to Treat An Abdominal Aortic Aneurysm with Hostile Proximal Neck.

Endovascular aneurysm repair (EVAR) actually represents the treatment of choice for most patients affected by abdominal aortic aneurysm (AAA). However, the feasibility of EVAR depends on anatomical characteristics of abdominal aorta and iliofemoral axis. We present the case of an 82-year-old man affected by severe left hydronephrosis, kidney tumor, and ureteral tumor requiring nephrectomy, who also presented a very voluminous AAA with a large diameter (96 mm), and a large proximal neck (39 mm) with severe angulation of the proximal neck (>60°). The patient was considered unfit for traditional EVAR and open surgery. Possible alternatives such as fenestrated endovascular abdominal aortic aneurysm repair and chimney technique were excluded; therefore he was treated combining Valiant Captivia endoprosthesis with the AFX unibody, with a good final result. However, this particular alternative adopted for hostile proximal neck needs long-term follow-up.

The role of procalcitonin as a marker of diabetic foot ulcer infection.

Foot ulcers are frequent in diabetic patients and are responsible for 85% of amputations, especially in the presence of infection. The diagnosis of diabetic foot ulcer infection is essentially based on clinical evaluation, but laboratory parameters such as erythrocyte sedimentation rate (ESR), white blood count (WBC), C-reactive protein (CRP) and, more recently, procalcitonin (PCT) could aid the diagnosis, especially when clinical signs are misleading. Fifteen diabetic patients with infected foot ulcers were admitted to our department and were compared with an additional group of patients with non-infected diabetic foot ulcers (NIDFUs). Blood samples were collected from all patients in order to evaluate laboratory markers. In the current study, the diagnostic accuracy of PCT serum levels was evaluated in comparison with other inflammatory markers such as CRP, ESR and WBC as an indicator to make the distinction between infected diabetic foot ulcers (IDFUs) and NIDFUs. CRP, WBC, ESR and especially PCT measurements represent effective biomarkers in the diagnosis of foot infections in diabetic patients particularly when clinical signs are misleading.

From varices to venous ulceration: the story of chronic venous disease described by metalloproteinases.

Chronic venous disease (CVD) and its most frightening complication, chronic venous ulceration (CVU), represent an important socioeconomic burden in the western world. Metalloproteinases have been identified in the pathogenesis of several vascular diseases such as venous problems. The aim of this study was to evaluate a broad range of metalloproteinases, such as matrix metalloproteinases (MMPs), ADAMs (a disintegrin and metalloproteinases) and ADAMTSs (a disintegrin and metalloproteinases with thrombospondin motifs) and their inhibitors, tissue inhibitor of metalloproteinases (TIMPs) and a related protein, neutrophil gelatinase-associated lipocalin (NGAL), in patients with CVD in order to correlate their serum levels with each stage of the disease. We performed a multicenter open-label study that comprised the enrolment of 541 patients with CVD of clinical stages C1-C6, (178 males, 363 females; mean age 57·29, median age 53·72, age range 29-81); 29 subjects without CVD were included in this study (9 males and 20 females; mean age 54·44, median age 50, age range 28-84) as the control group. Enzyme-linked immunosorbent assay (ELISA) was performed for measuring serum levels of proteases and related proteins. The study found that the serum elevation of MMP-2, ADAMTS-1 and ADAMTS-7 appeared to be correlated with the initial stages of CVD, whereas the serum elevation of MMP-1, MMP-8, MMP-9, NGAL, ADAM-10, ADAM-17 and ADAMTS-4 was particularly involved in skin change complications. This study showed that each stage of CVD may be described by particular patterns of metalloproteinases, and this may have therapeutic implications in discovering new targets and new drugs for the treatment of CVD.

An Uncommon Case of Type III Endoleak Treated with a Custom-made Thoracic Stent Graft.

Endovascular aortic repair (EVAR) has been shown to be a valid and minimally invasive alternative to open abdominal aortic aneurysm repair. A major shortcoming for EVAR is the need to submit patients to regular follow-up to detect potential complications such as endoleak, limb occlusion, aneurysm expansion, aneurysm rupture, infection, structural failure, and migration. In this case report, we describe an uncommon case of late type III endoleak due to complete detachment of the stent-graft main body segment from its suprarenal uncovered fixation stent. It was treated with a custom-made Relay(®) NBS Plus (Bolton Medical, Barcelona, Spain) thoracic stent graft which also provided extra suprarenal fixation of the thoracic stent graft in the proximal neck. The postoperative period was uneventful and a computed tomography scan 1 year later revealed proper positioning of the stent graft and no signs of endoleak. The successful strategy chosen to correct this complication was at the same time original and infrequent, and also avoided potential complications related to open surgical repair and general anesthesia.

Spinal Cord Stimulation Therapy for the Treatment of Concomitant Phantom Limb Pain and Critical Limb Ischemia.

Phantom limb pain (PLP) is a chronic condition experienced by about 80% of patients who have undergone amputation. In most patients, both the frequency and the intensity of pain attacks diminish with time, but severe pain persists in about 5-10%. Probably, factors in both the peripheral and central nervous system play a role in the occurrence and persistence of pain in the amputated lower limb. The classical treatment of PLP can be divided into pharmacologic, surgical, anesthetic, and psychological modalities. Spinal cord stimulation (SCS) does not represent a new method of treatment for this condition. However, the concomitant treatment of PLP and critical lower limb ischemia by using SCS therapy has not yet been described in the current literature. The aim of the present article is to highlight the possibility of apply SCS for the simultaneous treatment of PLP and critical lower limb ischemia on the contralateral lower limb after failure of medical therapy in a group of 3 patients, obtaining pain relief in both lower limbs, delaying an endovascular or surgical revascularization. After SCS implantation and test stimulation, the pain was reduced by 50% on both the right and the left side in all our patients. The main indications for permanent SCS therapy after 1 week of test stimulation were represented by transcutaneous oxygen (TcPO2) increase >75%, decrease of opioids analgesics use of at least 50% and a pain maintained to within 20-30/100 mm on visual analog scale.

Old and New Techniques as a Safe Hybrid Approach for Carotid Tandem Lesions.

BACKGROUND: Carotid revascularization is performed to prevent stroke. Carotid tandem lesions represent a challenge for treatment, and a hybrid approach may result effective. CASE REPORT: A high-risk 65-year-old woman presented with a "tandem lesion" of left common and internal carotid artery. She was deemed unfit for "simple" standard carotid endarterectomy (CEA). A "single-step" safe hybrid procedure was scheduled for the patient. A "Cormier" carotid vein graft bypass with a retrograde stenting was performed under local anesthesia. CONCLUSIONS: The "safe hybrid procedure" for tandem lesions of the common and internal carotid artery is effective and suitable in high-risk patients in a high-volume centers.

Updates in Pathophysiology, Diagnosis and Management of Takayasu Arteritis.

BACKGROUND: Takayasu arteritis (TA) is a rare, systemic, inflammatory vasculitis of granulomatous nature, and still of unknown etiology. It mainly involves the aorta and its major branches and is more commonly seen in women of childbearing age and Asians. TA leads to stenosis, occlusion, or aneurysmal degeneration of large arteries, and its pathogenesis seems to be mainly due to an abnormal cell-mediated immunity, although other molecular and genetic abnormalities may contribute. The diagnosis and treatments lie on clinical and arteriographic findings. Because of its fluctuating course, both clinical scores and biomarkers are currently evaluated. The aim of this review is to report a comprehensive and methodologically robust state of the art about Takayasu arteritis, including the latest data and evidences in the definition, epidemiology, pathogenesis and etiology, clinical manifestations and classification, diagnosis, assessment of disease activity and progression, biomarkers, and treatment. METHODS: We searched all publications addressing definition, epidemiology, pathogenesis, etiology, classification, diagnosis, biomarkers, and treatment of TA. Randomized trials, cohort studies, and reviews were contemplated to give a breadth of clinical data. PubMed and Scopus were searched from August 2010 to November 2015. RESULTS: Of the 3,056 records found, 267 matched our inclusion criteria. After reading the full-text articles, we decided to exclude 169 articles because of the following reasons: (1) no innovative or important content; (2) no multivariable analysis; (3) insufficient data; (4) no clear potential biases or strategies to solve them; (5) no clear end-points; and (6) inconsistent or arbitrary conclusions. The final set included 98 articles. CONCLUSIONS: This review presents the last updates in all fields of Takayasu arteritis. Still today, large areas of TA pathogenesis and disease-activity assessment need to be further investigated to better treat patients with TA.

Effectiveness of prostaglandin E1 in patients with mixed arterial and venous ulcers of the lower limbs.

Mixed arterial and venous ulcers of the lower limbs are present in around 15-30% of patients with chronic venous ulcers (CVUs) and are considered difficult-to-heal wounds. The aim of this study was to evaluate the results of the treatment of mixed arterial and venous ulcers of the lower limbs with prostaglandin E1 (PGE1) infusion. This study was carried out in 48 consecutive patients. Patients who showed intolerability to PGE1, and patients with peripheral neuropathy, blood or systemic diseases, malignancy and acute wound infections or necrotic tissue on the wound bed were excluded. The patients were separated at random into two main groups: group I (25 patients) received standard treatment and PGE1 infusion. Group II (23 patients) received only standard treatment. Pre-treatment data indicated the area of ulceration. The number of healed ulcers and the variation in the area of ulceration were considered as endpoints. The endpoints were noticed after 120 days from the beginning of treatment. Healing occurred in 80% of limbs of group I and in 52·2% of limbs of group II patients. The average reduction in area was 92% versus 60% in patients of group I and II, respectively. During the whole treatment period, the incidence of adverse events was 8% in group I: there was one case of headache and one case of headache and hypotension combined. No side effects were recorded in patients of group II. In conclusion, PGE1 infusion is a determinant in the reduction of the healing time of mixed ulcers of the lower limbs.

Trophic effects of polynucleotides and hyaluronic acid in the healing of venous ulcers of the lower limbs: a clinical study.

The aim of this study was to evaluate the results of treatment of venous lower limbs ulcers through the topical application of polynucleotides and hyaluronic acid gel (PNHA): Nucliaskin S™ (Mastelli srl, San Remo, Italy). This study was carried out in 39 consecutive patients who were randomly allocated to two groups: group I (20 patients) received treatment with PNHA (topical gel application two times a week, for a total of 6 weeks); group II (19 patients) received only hyaluronic acid (HA) topical application. All patients received a surgical debridement of the ulcerative lesions before topical treatment with PNHA or HA. Pre-treatment data indicated the area of ulceration. The number of healed ulcers and the variation in area of ulceration were considered as endpoints. The endpoints were observed after 45 days from the beginning of treatment. Complete wound healing occurred in 60% of limbs of group I and in 22% of those of group II patients. The average area reduction was 67% versus 34% in patients of group I and II, respectively. No side effects were recorded in both groups. Our experience shows that PNHA has an elevated trophic effect and speeds the healing rate of venous lower limb ulcers. This treatment may be a valid option in clinical practice.