Community distress and risk of adverse outcomes after peripheral vascular intervention.

INTRODUCTION: Community distress is associated with adverse outcomes in patients with cardiovascular disease; however, its impact on clinical outcomes after peripheral vascular intervention (PVI) is uncertain. The Distressed Communities Index (DCI) is a composite measure of community distress measured at the zip code level. We evaluated the association between community distress, as measured by the DCI, and 24-month mortality and major amputation after PVI. METHODS: We used the Vascular Quality Initiative database, linked with Medicare claims data, to identify patients who underwent initial femoropopliteal PVI between 2017 and 2018. DCI scores were assigned using patient-level zip code data. The primary outcomes were 24-month mortality and major amputation. We used time-dependent receiver operating characteristic curve analysis to determine an optimal DCI value to stratify patients into risk categories for 24-month mortality and major amputation. Mixed Cox regression models were constructed to estimate the association of DCI with 24-month mortality and major amputation. RESULTS: The final cohort consisted of 16,864 patients, of whom 4734 (28.1%) were classified as having high community distress (DCI ≥70). At 24 months, mortality was elevated in patients with high community distress (30.7% vs 29.5%, P = .02), as was major amputation (17.2% vs 13.1%, P <.001). After adjusting for demographic and clinical characteristics, a 10-point higher DCI score was associated with increased risk of mortality (hazard ratio: 1.01; 95% confidence interval: 1.00-1.03) and major amputation (hazard ratio: 1.02; 95% confidence interval: 1.00-1.04). CONCLUSIONS: High community distress is associated with increased risk of mortality and major amputation after PVI.

Thirteen-Year Follow-Up Reverse Sural Artery Flap for Plantar Calcaneal Wound: A Case Report.

Reconstruction of soft tissue defects in the lower leg and foot after traumatic injury is a challenging problem owing to lack of locally reliable flaps. The traditional options for wound coverage often do not provide feasible or adequate treatment for many of these wounds. The lack of skin laxity in the lower leg and foot often make local flaps unavailable. Split-thickness skin grafts will not be robust enough. Free tissue flaps have a litany of potential complications and guaranteed comorbidities. The present case reinforces that appropriately selected patients with significant open bony and soft tissue trauma to the foot and ankle can be treated with a reverse sural artery fasciocutaneous flap. The reverse sural artery flap allows for full-thickness skin coverage with its own blood supply, maximizing the healing potential and should be considered a viable first option for soft tissue coverage.

Functional Results and Patient Satisfaction of First Metatarsophalangeal Joint Arthrodesis Using Dual Crossed Screw Fixation.

A total of 262 feet in 228 consecutive patients underwent first metatarsophalangeal joint (MPJ) fusion; thus, the present study is the largest single-surgeon patient series reported. The inclusion criteria included severe painful deformity of the first MPJ due to osteoarthritis, rheumatoid arthritis, or gouty arthritis and stage 3 or 4 hallux rigidus. The exclusion criteria were revision surgery of the first MPJ, fixation other than with dual crossed screws, and a postoperative follow-up period of <3 months. Fusion of the first MPJ was fixated with dual-crossed 3.0-mm screws. The office follow-up period was ≥3 months postoperatively and the survey follow-up period was ≥6 months postoperatively. The mean duration to radiographic evidence of arthrodesis was 7.00 ± 2.33 weeks, and 252 of the feet (96.18%) achieved successful arthrodesis. The mean postoperative office follow-up duration was 30.43 ± 6.59 weeks. The mean modified American College of Foot and Ankle Surgeons scale score was 51.2 ± 3.28 of maximum possible of 68 points. The mean subjective score was 37.1 ± 2.5 (maximum possible of 50 points), and the mean objective score was 14.5 ± 1.7 (maximum possible of 18 points). Furthermore, 200 patients (87.72%) reported that they had little to no pain, 187 (82.02%) reported they either mostly liked the appearance of their toe or liked it very much, and 173 (75.88%) reported that they could wear any type of shoe most or all the time after the operation. Of the respondents, 207 (90.79%) stated they would have the surgery repeated, and 197 (86.40%) would recommend the surgery to a family member or friend.

Endovascular revascularization of an occluded persistent sciatic artery for chronic limb-threatening ischemia in a patient with Coronavirus Disease 2019.

A persistent sciatic artery (PSA) is a rare embryologic variant that usually presents with aneurysmal degeneration. This report describes a 66-year-old man with severe comorbidities who presented with right forefoot gangrene and severe acute respiratory syndrome coronavirus 2 infection. Imaging revealed a unilateral PSA with a chronic occlusion at the level of the knee joint with no aneurysm. After coronavirus disease 2019 resolution, he underwent CO2 angiography with successful recanalization of the PSA, followed by transmetatarsal amputation that healed uneventfully. At follow-up after 16 months, he was noted to have asymptomatic thrombosis of his stent and, hence, no intervention was performed.

Retrospective evaluation of clinical outcomes in subjects with split-thickness skin graft: comparing V.A.C.® therapy and conventional therapy in foot and ankle reconstructive surgeries.

This retrospective study compared the clinical outcomes of negative pressure wound therapy with reticulated open cell foam (NPWT/ROCF) as delivered by Vacuum-Assisted Therapy(®) (V.A.C.(®) Therapy, KCI Licensing Inc., San Antonio, TX) to non-NPWT/ROCF conventional therapy (CT) in split-thickness skin graft (STSG) survival in all patients to determine whether NPWT/ROCF affects the outcome of the graft survival, in terms of overall graft take, duration of graft take, repeated grafts and complications. The authors conducted a 10-year retrospective review of 142 patients admitted to a level I trauma centre and treated with an STSG in foot and ankle reconstructive surgeries. Demographic data, wound etiology, dressing type used, time to graft take, NPWT/ROCF duration, complications and outpatient treatments were analysed. There were significantly fewer repeated STSGs required in the NPWT/ROCF group compared to CT [n = 3 (3·5%) versus n = 9 (16%); P = 0·006]. In assessing safety, there were fewer complications in graft failure (seroma, hematoma and infection) in the NPWT/ROCF group as compared to the CT group at 8·9 months (range: 1-12 months). NPWT/ROCF is an excellent alternative for securing an STSG and is associated with improved graft survival as measured by a reduction in the number of repeated STSGs and graft failure complications.

Wound Conforming Matrix Containing Purified Homogenate of Dermal Collagen Promotes Healing of Diabetic Neuropathic Foot Ulcers: Comparative Analysis Versus Standard of Care.

Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with a collagen Wound Conforming Matrix (WCM) or standard of care (SOC). Approach: WCM, a highly purified homogenate of 2.6% fibrillar bovine dermal collagen that conforms to the wound surface, was evaluated in comparison to daily saline-moistened gauze dressing changes (SOC) as part of a retrospective subset analysis of a randomized controlled trial in DFU. Following a 2-week run-in period during which patients received SOC, patients whose wounds did not reduce in area by >30% during run-in were randomly assigned to receive WCM (one or two applications) or SOC. Results: Statistically significant acceleration of early healing rates was observed following a single application of WCM with weekly outer dressing changes compared with daily saline-moistened gauze dressing changes (SOC). Over a 4-week period, 50% of patients receiving a single application of WCM achieved ≥75% reduction in wound area compared with 13% for SOC. WCM appeared to be safe and well tolerated, with no adverse events related to treatment and no evidence of an immunologic reaction to bovine collagen. Innovation: WCM is unique in its intimate contact with the wound bed and its ability to progress a wound toward healing with a single application. Conclusion: WCM is a treatment modality to accelerate DFU healing rates, with the potential to reduce the likelihood of infection and other complications, and cost of care.

Role of integrins and focal adhesion kinase in the orientation of dermal fibroblasts exposed to cyclic strain.

Stretch is applied to skin under normal physiological conditions, for example pregnancy, or artificially using soft tissue expanders. Because cells are known to orient in response to the application of mechanical forces, the current studies were carried out to assess the effects of stretch on dermal fibroblast orientation and cell signalling. Dermal fibroblasts were seeded onto collagen-coated flexible membranes and grown to 70-80% confluence. Membranes were then deformed at 10 cycles per minute by the application of 135 mmHg subatmospheric pressure. This corresponded to strain levels of 0-24% from the centre to extremity of the flexible membrane. We show that a minimum of 15% cell stretch is required to significantly stimulate the fibroblast orientation response. focal adhesion kinase (FAK), p38 and Rho were activated in fibroblasts exposed to cyclic stretch and incubation of cells with anti-integrin beta1 before the application of stretch abrogated fibroblast orientation, as well as FAK, p38 and Rho activation. Fibroblast orientation in response to cyclic stretch is mediated at least in part by integrin beta1 through phosphorylation of FAK, p38 and activation of Rho.

Safety of Deep Sedation in Patients Undergoing Full-Thickness Skin Graft Harvesting and Skin Graft Reconstruction for Limb Salvage An Outcome Analysis.

BACKGROUND:: Studies on obtaining donor skin graft using intravenous sedation for patients undergoing major foot surgeries in the same operating room visit have not previously been reported. The objective of this retrospective study is to demonstrate that intravenous sedation in this setting is both adequate and safe in patients undergoing skin graft reconstruction of the lower extremities in which donor skin graft is harvested from the same patient in one operating room visit. METHODS:: Medical records of 79 patients who underwent skin graft reconstruction of the lower extremities by one surgeon at the Yale New Haven Health System between November 1, 2008, and July 31, 2014, were reviewed. The patients' demographic characteristics, American Society of Anesthesiologists class, comorbid conditions, intraoperative analgesic administration, estimated blood loss, total operating room time, total postanesthesia care unit time, and postoperative complications within the first 72 hours were reviewed. RESULTS:: This study found minimal blood loss and no postoperative complications, defined as any pulmonary or cardiac events, bleeding, admission to the intensive care unit, or requirement for invasive monitoring, in patients who underwent major foot surgery in conjunction with full-thickness skin graft. CONCLUSIONS:: We propose that given the short duration and peripheral nature of the procedures, patients can safely undergo skin graft donor harvesting and skin graft reconstruction procedures with intravenous sedation regardless of American Society of Anesthesiologists class in one operating room visit.

Single-stage surgical treatment of noninfected diabetic foot ulcers.

A retrospective study was undertaken to evaluate a single-stage approach in the treatment of noninfected, chronic, well-perfused diabetic foot wounds. This single-stage approach consisted of total excision of the ulcer with broad exposure, correction of the underlying osseous deformity, and immediate primary closure using a local random flap. Four hundred cases of pedal ulcers were analyzed by chart review. Of those, 67 cases underwent a single-stage surgical treatment and were analyzed for length of hospital stay, postoperative complications, time to heal, recurrence of the ulcer, and postprocedure ambulatory status. The age of the ulcers before surgery was 12 +/- 12 months (mean +/- SD), with a range of 1 to 60. The median perioperative hospital stay was 5 +/- 7.6 days. All patients were followed until the wounds were healed or to amputation. The median total time to heal was 30.8 +/- 40 days. Ninety-seven percent of the wounds healed. The recurrence rate of ulceration was 10.4 percent (seven of 67), over a time span of up to 6 years. All but one patient returned to previous levels of ambulation, and many patients had improved levels of ambulation. The single-stage approach eliminated the need for additional surgical procedures, with their associated costs and risks. In addition, healing times were significantly reduced, resulting in decreased hospital stays and subsequent costs and providing the patient with an expedient return to footwear so that bipedal function could be restored. Most importantly, by addressing the underlying bony pathologic findings, the recurrence rates were also drastically reduced.

Vascular evaluation and arterial reconstruction of the diabetic foot.

Findings of diminished or absent pulses, pallor on elevation, redness of the foot on lowering of the leg, sluggish refilling of the toe capillaries, and thickened nails or absence of toe hair are consistent with impaired arterial perfusion to the foot. When ischemia is recognized as contributing to pedal ulceration and infection in the diabetic foot, quantitation of its severity may be difficult. Standard clinical evaluation of trophic changes is limited in an infected foot with its accompanying swelling, edema, and erythema. A palpable pedal pulse does not preclude the possibility of the presence of limb-threatening ischemia. Additional non-invasive vascular studies should be undertaken for these patients. Management of the diabetic foot is often a complex clinical problem. However, the principles of care are simple, including correction of systemic factors, such as blood glucose control, cardiovascular risk factor management, and smoking, as well as local factor correction, such as debridement, pressure relief, infection control, and revascularization when indicated. When a patient presents with evidence of infection, adequate drainage and antibiotic therapy are mandatory. The next step should be performed to differentiate the more common neuropathic ulcerations from the truly ischemic ulceration. Symptoms of rest pain or claudication are not often helpful because many of these patients are asymptomatic as a result of the presence of their neuropathy and inactivity. If an infected foot requires debridement or open partial forefoot amputation, observing the wound on a daily base is also important. Once infection is eradicated, there should be prompt signs of healing, including the development of wound granulation within several days. If wounds are not showing signs of prompt healing, arteriography is necessary. Early aggressive drainage, debridement, and local foot amputations combined with liberal use of revascularization results in cumulative limb salvage of 74% at 5 years in high-risk groups. Others report that pedal bypass to the ischemic infected foot is effective and safe as long as infection adequately controlled. These studies strongly suggest that early recognition and aggressive surgical drainage of pedal sepsis followed by surgical revascularization is critical to achieving maximal limb salvage in the high-risk population. Patients who have diabetes present a unique challenge in lower extremity revascularization because of the distal origination of many bypasses, distal distribution of the occlusive disease, and the frequently calcified arterial wall. An aggressive multidisciplinary approach to foot disease associated with diabetes involving the primary care provider, medical specialists, interventional radiology, and podiatric, plastic, and vascular surgeons will provide optimal medical and surgical care. Peripheral vascular disease is highly treatable if intervention is instituted in a timely and collegial fashion.

Evaluation of wound care and health-care use costs in patients with diabetic foot ulcers treated with negative pressure wound therapy versus advanced moist wound therapy.

BACKGROUND: We conducted a post-hoc retrospective analysis of patients enrolled in a randomized controlled trial to evaluate overall costs of negative pressure wound therapy (NPWT; V.A.C. Therapy; KCI USA, Inc, San Antonio, Texas) versus advanced moist wound therapy (AMWT) in treating grade 2 and 3 diabetic foot wounds during a 12-week therapy course. METHODS: Data from two study arms (NPWT [n = 169] or AMWT [n = 166]) originating from Protocol VAC2001-08 were collected from patient records and used as the basis of the calculations performed in our cost analysis. RESULTS: A total of 324 patient records (NPWT = 162; AMWT = 162) were analyzed. There was a median wound area reduction of 85.0% from baseline in patients treated with NPWT compared to a 61.8% reduction in those treated with AMWT. The total cost for all patients, regardless of closure, was $1,941,472.07 in the NPWT group compared to $2,196,315.86 in the AMWT group. In patients who achieved complete wound closure, the mean cost per patient in the NPWT group was $10,172 compared to $9,505 in the AMWT group; the median cost per 1 cm(2) of closure was $1,227 with NPWT and $1,695 with AMWT. In patients who did not achieve complete wound closure, the mean total wound care cost per patient in the NPWT group was $13,262, compared to $15,069 in the AMWT group. The median cost to close 1 cm(2) in wounds that didn't heal using NPWT was $1,633, compared to $2,927 with AMWT. CONCLUSIONS: Our results show greater cost effectiveness with NPWT versus AMWT in recalcitrant wounds that didn't close during a 12-week period, due to lower expenditures on procedures and use of health-care resources.

The role of plastic surgery for soft tissue coverage of the diabetic foot and ankle.

The goal of wound healing is to obtain the best closure through the least morbid means. In the surgical treatment of the diabetic foot and ankle, the reconstructive foot and ankle surgeon is tasked with the challenge of repairing a variety of tissue defects. The decision for wound closure depends on the location of the wound and host factors. In order of increasing complexity, the clinician should consider the reconstruction decision ladder algorithm. Wound evaluation coupled with the knowledge of various closure techniques and their indications will arm the surgeon with the tools for a successful closure.

Charcot neuroarthropathy of the foot and ankle: diagnosis and management strategies.

This article reviews current literature discussing the etiology, pathophysiology, diagnosis and imaging, and conservative and surgical treatment of Charcot osteoarthropathy. The treatment of Charcot osteoarthropathy with concurrent osteomyelitis is also discussed.

Prosthetic options available for the diabetic lower limb amputee.

Although the rate of lower limb amputation in patients with diabetes is decreasing, amputation still remains a major complication of diabetes. Prosthetics have been long used to help amputees ambulate. The last decade has seen many advances in prostheses with the enhanced understanding of the mechanics of ambulation and improved use of technology. This review describes the different types of prosthetic options available for below knee, ankle, and foot amputees, emphasizing the latest advances in prosthetic design.

Charcot foot and ankle with osteomyelitis.

This paper presents a review of the current literature discussing topics of Charcot osteoarthropathy, osteomyelitis, diagnosing osteomyelitis, antibiotic management of osteomyelitis, and treatment strategies for management of Charcot osteoarthropathy with concurrent osteomyelitis.

Lower extremity limb salvage with cryoplasty: a single-center cohort study.

Endovascular techniques have been playing an increasing role in managing lower extremity chronic critical limb ischemia (CLI) in patients considered poor or non-candidates for surgical revascularization secondary to co-morbidities such as coronary artery disease, uncontrolled hypertension, diabetes mellitus or inadequate conduit. This study reviews our recent clinical experience in the treatment of peripheral artery disease solely using cryoplasty. A retrospective cohort study was performed. The cohort consisted of 88 patients who underwent lower extremity revascularization utilizing cryoplasty between December 2003 and August 2007. Indications for intervention included poor wound healing after forefoot amputation or persistent ulceration of the foot, disabling claudication and rest pain. Kaplan-Meier analysis was performed to assess salvage rates. One hundred twenty-six lesions were treated in 88 patients. Technical success rate was 97%. Limb salvage rates were 75 and 63% for patients with critical limbs ischemia after one and three years, respectively. A history of smoking was associated with a threefold increased risk of limb loss. In conclusion, endovascular management of lower extremity lesions with cryoplasty is an emerging and viable paradigm in the treatment of CLI in an attempt to preserve limbs and avoid major amputations.

An open-label, three-arm pilot study of the safety and efficacy of topical Microcyn Rx wound care versus oral levofloxacin versus combined therapy for mild diabetic foot infections.

BACKGROUND: This randomized, prospective, multicenter, open-label study was designed to test whether a topical, electrolyzed, superoxidized solution (Microcyn Rx) is a safe and effective treatment for mildly infected diabetic foot ulcers. METHODS: Sixty-seven patients with ulcers were randomized into three groups. Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation. Patients were evaluated on day 3, at the end of treatment on day 10 (visit 3), and 14 days after completion of therapy for test of cure (visit 4). RESULTS: In the intention-to-treat sample at visit 3, the clinical success rate was higher in the Microcyn Rx alone group (75.0%) than in the saline plus levofloxacin group (57.1%) or in the Microcyn Rx plus levofloxacin group (64.0%). Results at visit 4 were similar. In the clinically evaluable population, the clinical success rate at visit 3 (end of treatment) for patients treated with Microcyn Rx alone was 77.8% versus 61.1% for the levofloxacin group. The clinical success rate at visit 4 (test of cure) for patients treated with Microcyn Rx alone was 93.3% versus 56.3% for levofloxacin plus saline-treated patients. This study was not statistically powered, but the high clinical success rate (93.3%) and the P value (P = .033) suggest that the difference is meaningfully positive for Microcyn Rx-treated patients. CONCLUSIONS: Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections.

Plantar foot donor site as a harvest of a split-thickness skin graft.

The authors present a minimally invasive procedure for harvesting a split thickness skin graft (STSG) from the plantar surface of the foot. This is another option to consider for soft tissue reconstruction of diabetic foot wounds to help restore form and function and to prevent amputation. The authors do not recommend this technique for all soft tissue wounds of the toes and plantar aspect of the foot but believe it is a viable option for selected small diabetic foot wounds that may benefit from a STSG.

Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate safety and clinical efficacy of negative pressure wound therapy (NPWT) compared with advanced moist wound therapy (AMWT) to treat foot ulcers in diabetic patients. RESEARCH DESIGN AND METHODS: This multicenter randomized controlled trial enrolled 342 patients with a mean age of 58 years; 79% were male. Complete ulcer closure was defined as skin closure (100% reepithelization) without drainage or dressing requirements. Patients were randomly assigned to either NPWT (vacuum-assisted closure) or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. The trial evaluated treatment until day 112 or ulcer closure by any means. Patients whose wounds achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound examination and tracings. RESULTS: A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of 169, 43.2%) than with AMWT (48 of 166, 28.9%) within the 112-day active treatment phase (P = 0.007). The Kaplan-Meier median estimate for 100% ulcer closure was 96 days (95% CI 75.0-114.0) for NPWT and not determinable for AMWT (P = 0.001). NPWT patients experienced significantly (P = 0.035) fewer secondary amputations. The proportion of home care therapy days to total therapy days for NPWT was 9,471 of 10,579 (89.5%) and 12,210 of 12,810 (95.3%) for AMWT. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months. CONCLUSIONS: NPWT appears to be as safe as and more efficacious than AMWT for the treatment of diabetic foot ulcers.