A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities.

Multicenter, phase-4, randomized, comparative-efficacy study in patients with VLUs or DFUs comparing for noninferiority the percentage change in target ulcer dimensions (area, depth, and volume) a single-use negative pressure wound therapy (s-NPWT) system versus traditional NPWT (t-NPWT) over a 12-week treatment period or up to confirmed healing. Baseline values were taken at the randomization visit. Randomized by wound type and size, 164 patients with non-infected DFUs and VLUs were included. The ITT population was composed of 161 patients (101 with VLUs, 60 with DFUs) and 115 patients completed follow-up (64 in the s-NPWT group and 51 in the t-NPWT group) (PP population). The average age for all patients was 61.5 years, 36.6% were women, and treatment groups were statistically similar at baseline. Primary endpoint analyses on wound area reduction demonstrated statistically significant reduction in favor of s-NPWT (p = 0.003) for the PP population and for the ITT population (p < 0.001). Changes in wound depth (p = 0.018) and volume (p = 0.013) were also better with s-NPWT. Faster wound closure was observed with s-NPWT (Cox Proportional Hazards ratio (0.493 (0.273, 0.891); p = 0.019) in the ITT population. Wound closure occurred in 45% of patients in the s-NPWT group vs. 22.2% of patients in the t-NPWT group (p = 0.002). Median estimate of the time to wound closure was 77 days for s-NPWT. No estimate could be provided for t-NPWT due to the low number of patients achieving wound closure. Device-related AEs were more frequent in the t-NPWT group (41 AEs from 29 patients) than in the s-NPWT group (16 AEs from 12 patients). The s-NPWT system met noninferiority and achieved statistical superiority vs. t-NPWT in terms of wound progression toward healing over the treatment period. When NPWT is being considered for the management of challenging VLUs and DFUs, s-NPWT should be considered a first choice over other types of NPWT.

Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis.

BACKGROUND: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. METHODS: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. Subjects were randomized to receive 1 injection, in the affected area, of micronized dHACM (n=73) or 0.9% sodium chloride placebo (n=72). Safety/efficacy assessments were conducted at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months postinjection, using visual analog scale (VAS) for pain, Foot Function Index-Revised (FFI-R) score, and presence/absence of adverse events. Primary outcome was mean change in VAS score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Secondary outcome was mean change in FFI-R score between baseline and 3 months expressed as difference in means for treatment versus control subjects. RESULTS: Baseline VAS scores were similar between groups. At the 3-month follow-up, mean VAS scores in the treatment group were 76% lower compared with a 45% reduction for controls ( P < .0001), FFI-R scores for treatment subjects had mean reduction of 60% versus baseline, whereas control subjects had mean reduction of 40% versus baseline ( P = .0004). Of 4 serious adverse events, none were related to study procedures. CONCLUSION: Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. LEVEL OF EVIDENCE: Level I, prospective randomized trial.

Society for Vascular Surgery limb stage and patient risk correlate with outcomes in an amputation prevention program.

OBJECTIVE: Clinical decision making and accurate outcomes comparisons in advanced limb ischemia require improved staging systems. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System (Wound extent, Ischemia, and foot Infection [WIfI]) was designed to stratify limb outcomes based on three major factors-wound extent, ischemia, and foot infection. The Project or Ex-Vivo vein graft Engineering via Transfection III (PREVENT) III (PIII) risk score was developed to stratify patients by expected amputation-free survival (AFS) after surgical revascularization. This study was designed to prospectively assess limb and patient-based staging for predicting outcomes of hospitalized patients in an amputation prevention program. METHODS: This study undertook a retrospective analysis of prospectively gathered registry data of consecutive patients with limb-threatening conditions admitted to a fully integrated vascular/podiatry service over a 16-month period. Upon admission, limb risk was stratified using the WIfI system and patient risk was categorized using PIII classification. Patients were assessed for perioperative and postdischarge outcomes, and their relationship to staging at admission was analyzed. RESULTS: There were 174 threatened limbs (143 hospitalized patients) stratified by WIfI stage (1%-12%, 2%-28%, 3%-24%, 4%-28%, 5%-3%, unstaged-5%) and PIII risk (34% low, 49% moderate, and 17% high risk). Diabetes and end-stage renal disease were associated with WIfI stage (P = .006 and P = .018) and PIII risk (P = .003 and P < .001). Perioperative (30-day) events included 3% mortality, 8% major adverse cardiovascular events and 2.4% major amputation. There were 119 limbs (71%) that underwent revascularization, including 108 infrainguinal reconstructions (endovascular or open revascularization). Rate of revascularization increased with WIfI stage (P < .001), concomitant with the number of podiatric procedures, minor amputations, and initial hospital duration of stay (all P < .001). Increased WIfI stage was associated with major adverse limb events (P = .018), reduced limb salvage (P = .037), and decreased AFS (P = .048). In contrast, PIII risk category was associated with mortality (P < .001) and AFS (P < .001). Among infrainguinal reconstruction procedures, there was a similar distribution of endovascular (46%) and surgical (54%) interventions. Freedom from major adverse limb events was best for autogenous vein bypass (P = .025), and surgical revascularization was associated with improved limb salvage among the most severely threatened limbs (WIfI stage 4: 95% limb salvage for open bypass vs 68% limb salvage for endovascular; P = .026). CONCLUSIONS: Among patients hospitalized with limb-threatening conditions and treated by a multidisciplinary amputation prevention team, PIII risk correlates with mortality whereas WIfI stage strongly predicts initial hospital duration of stay, and key mid-term limb outcomes. Surgical revascularization performed best in the limbs at greatest risk (WIfI stage 4), and autogenous vein bypass was the preferred conduit for open bypass. These data support the use of WIfI and PIII as complementary staging tools in the management of chronic limb-threatening ischemia.

Outcomes of neuroischemic wounds treated by a multidisciplinary amputation prevention service.

BACKGROUND: Multidisciplinary amputation prevention teams decrease the frequency of major amputations by increasing the use of revascularization procedures and minor amputations. The outcomes of wound healing, wound recurrence, and ambulatory status are assumed to be improved but are not routinely reported. This study investigates the midterm outcomes of neuroischemic wounds treated by our multidisciplinary team. METHODS: A retrospective review of patients with neuroischemic wounds treated at a single institution amputation prevention clinic from March 2012 to July 2013. Patient demographics, wound characteristics, procedural details, and clinical and functional outcomes were reviewed. Clinical end points under study included time to wound healing, reulceration rate, and ambulatory status. RESULTS: Over 16 months, there were 202 new patients and 1,355 clinic visits. Ninety-one limbs from 89 patients were treated for complex neuroischemic wounds. In 67% (61 of 91) of limbs, wounds were present for >6 weeks before referral. A history of previous revascularization was present in 39% (31 of 91), and 28% (22 of 91) had a previous minor amputation. Forty-one percent of wounds (38 of 91) were limited to the toes or the forefoot whereas 24% (22 of 91) involved the hindfoot or ankle. A total of 151 podiatric and 86 vascular interventions were performed, with an equal distribution of endovascular and open revascularizations. Complete healing was observed for 59% of wounds (54 of 91) over the observation period (median follow up, 207 days; range 56-561 days), and the average time to full healing was 12 weeks. Hindfoot wounds were predictive of failure to heal (odds ratio, 0.21; P < 0.01; 95% confidence interval, 0.06-0.68). Nineteen percent of patients (17 of 91) developed a new wound in the ipsilateral leg during follow-up. Three major amputations were performed (2 below-knee amputation and 1 above-knee amputation) for a major/minor amputation ratio of 0.06. Ambulatory status was preserved or improved in 74% (67 of 91) of patients. The 30-day readmission rate was 11%, which was lower than that observed (21%) in a contemporaneous but all-inclusive population of lower extremity revascularization procedures performed at our institution. CONCLUSIONS: Multidisciplinary limb salvage teams effectively heal wounds and maintain ambulatory status in patients with limb-threatening neuroischemic wounds. Patient specific factors, such as hindfoot or ankle wounds, can adversely influence the outcome. Even with aggressive care, healing can be prolonged and a substantial proportion of patients can be expected to have a recurrence, making subsequent surveillance mandatory. Our data also suggest that a coordinated amputation prevention program may help to minimize hospital readmissions in this high-risk population.

A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers.

This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.