Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial.

Objective: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population.

Real-World Comparative Effectiveness Assessment Study of a Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial and a Cryopreserved Cadaveric Skin Allograft for Use in Diabetic Foot Ulcers - A Non-inferiority Analysis.

Objective: To determine the effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) and a cryopreserved cadaveric skin allograft (CCSA) for use in diabetic foot ulcers (DFUs).

Methods: A real-world data study was conducted on 989 DFUs analyzed digitally. Of these, 325 and 664 DFUs were treated with PCMP and CCSA, respectively.

Real-world data analysis of bilayered living cellular construct and fetal bovine collagen dressing treatment for pressure injuries: a comparative effectiveness study.

To determine the effectiveness of bilayered living cellular construct (BLCC) versus a fetal bovine collagen dressing (FBCD) in pressure injuries (PRIs). A real-world data study was conducted on 1352 PRIs analyzed digitally. 1046 and 306 PRIs were treated with BLCC and FBCD, respectively.

Effectiveness of a purified type I collagen matrix plus the antimicrobial polyhexamethylene biguanide for use in cutaneous wounds: analysis of a population of three combined registries.

Introduction: Chronic wounds represent a significant burden to the health care system and patients.

Objective: This study determined the effectiveness of a wound scaffold comprised of PCMP for use in nonhealing, cutaneous wounds; this study analyzes pooled data from the population of 3 combined registries.

Materials And Methods: A total of 3 combined registry populations were pooled from a single-center study of 41 patients, a single-center study of 86 patients, and the RESPOND Registry of 307 patients treated at 28 centers.

A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis.

Background: The RESPOND registry study was the first prospective noninterventional study evaluating the real-world effectiveness of a native type 1 collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) barrier in nonhealing wounds.

Purpose: The objective of this secondary analysis was to describe the effects of PCMP in the subgroup of patients with venous leg ulcers (VLUs) in the RESPOND registry.

Methods: RESPOND was a 28-site, prospective, noninterventional study for up to 32 weeks.

Effectiveness of type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of pressure injuries.

Introduction: The first prospective noninterventional registry study (RESPOND) evaluated the clinical effectiveness of a native type I collagen matrix plus polyhexamethylene biguanide antimicrobial barrier (PCMP) in various nonhealing wounds. This product is intended for the management of partial- and full-thickness wounds and acts as an effective barrier to reduce microbes penetrating through the dressing. The RESPOND study demonstrated that PCMP has clinically meaningful benefits in managing a variety of wounds.

Type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of cutaneous wounds.

Determine the effectiveness of purified native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) on cutaneous wounds. A prospective cohort study of 307 patients (67 venous leg ulcers, 62 diabetic foot ulcers, 45 pressure ulcers, 54 post-surgical wounds and 79 other wounds) was conducted. Cox wound closure for PCMP was 73% at week 32.

Evaluation of Wound Closure Rates Using a Human Fibroblast-derived Dermal Substitute Versus a Fetal Bovine Collagen Dressing: A Retrospective Study.

Unlabelled: Diabetic foot ulcers (DFUs) are associated with an increased risk for serious and costly outcomes such as osteomyelitis, amputation, and hospitalization.

Purpose: A retrospective study was conducted to evaluate the proportion of patients healed and time to healing of DFUs treated with a human fibroblast-derived dermal substitute (HFDS) or a fetal bovine collagen dressing (FBCD).

Methods: Data from patients with a DFU who received the first treatment in 2014 were extracted from the electronic record database of 93 wound care centers.

A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers.

Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.

Comparative effectiveness of a human fibroblast-derived dermal substitute and a viable cryopreserved placental membrane for the treatment of diabetic foot ulcers.

To compare a human fibroblast-derived dermal substitute (HFDS) to a viable cryopreserved placental membrane (vCPM) for use in diabetic foot ulcers (DFUs). An electronic medical record database of 1622 refractory DFUs with areas 1-40 cm was analyzed. Cox estimates of wound closure for HFDS (1444 wounds) were significantly greater (p = 0.

Comparative effectiveness of a bilayered living cellular construct and an acellular fetal bovine collagen dressing in the treatment of venous leg ulcers.

To compare the effectiveness of bilayered living cellular construct (BLCC) and an acellular fetal bovine collagen dressing (FBCD) for the treatment of venous leg ulcers. Data from WoundExpert (Net Health, PA, USA) was used to analyze 1021 refractory venous leg ulcers treated at 177 facilities. Kaplan-Meier analyses showed that BLCC (893 wounds) was superior to FBCD (128 wounds), p = 0.

Comparative Effectiveness of a Bioengineered Living Cellular Construct and Cryopreserved Cadaveric Skin Allograft for the Treatment of Venous Leg Ulcers in a Real-World Setting.

A variety of advanced biological therapies are available for the treatment of chronic wounds such as venous leg ulcers (VLUs), but real-world comparative effectiveness data that can help guide decisions around treatments are currently lacking. This analysis was designed to compare the effectiveness of a bioengineered living cellular construct (BLCC) to a cryopreserved cadaveric skin allograft (CCSA) for the treatment of VLUs. Treatment records were collected from a large wound care-specific electronic medical record database on 717 patients (799 VLUs) receiving treatment at 177 wound care centers.

The Comparative Effectiveness of a Human Fibroblast Dermal Substitute versus a Dehydrated Human Amnion/Chorion Membrane Allograft for the Treatment of Diabetic Foot Ulcers in a Real-world Setting.

Background: Impaired wound healing is associated with serious complications in patients with diabetes. Diabetic foot ulcers (DFUs) can lead to costly complications and an increased mortality rate. Standard treatments for DFUs often need to be augmented with adjunctive therapies designed to stimulate healing in recalcitrant wounds.

Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting.

We evaluated the comparative effectiveness of a bioengineered living cellular construct (BLCC) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of diabetic foot ulcers (DFUs). Using a wound care-specific electronic medical record database, we assessed real-world outcomes in 218 patients with 226 DFUs receiving treatment in 2014 at 99 wound care centers. The analysis included DFUs ≥1 and <25 cm2 with duration <=1 year and area reduction ≤20% in 14 days prior to treatment (N=163, BLCC; N=63, dHACM).

Comparative effectiveness of a bilayered living cellular construct and a porcine collagen wound dressing in the treatment of venous leg ulcers.

Using data from a national wound-specific electronic medical record (WoundExpert, Net Health, Pittsburgh, PA), we compared the effectiveness of a bilayered living cellular construct (BLCC) and an acellular porcine small intestine submucosa collagen dressing (SIS) for the treatment of venous leg ulcer. Data from 1,489 patients with 1,801 refractory venous leg ulcers (as defined by failure to have >40% reduction in size in the 4 weeks prior to treatment) with surface areas between 1 and 150 cm(2) in size, treated between July 2009 and July 2012 at 158 wound care facilities across the US were analyzed. Patient baseline demographics and wound characteristics were comparable between groups.

Effect of fixed-dose combined isosorbide dinitrate/hydralazine in elderly patients in the African-American heart failure trial.

Background: Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) significantly improved outcomes in patients with advanced heart failure (HF) receiving background neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT). In this analysis, we investigated treatment effects by age <65 or ≥65 years.

Methods And Results: Time-to-event curves were produced by the Kaplan-Meier method.

Dysfunctional corin i555(p568) allele is associated with impaired brain natriuretic peptide processing and adverse outcomes in blacks with systolic heart failure: results from the Genetic Risk Assessment in Heart Failure substudy.

Background: Corin, a transmembrane serine protease expressed in cardiomyocytes, cleaves pro-atrial natriuretic peptide and pro-brain natriuretic peptide (BNP) into biologically active peptide hormones. The minor corin I555(P568) allele, defined by the T555I and Q568P mutations, is common in persons of African ancestry and associated with increased risk for hypertension and cardiac concentric hypertrophy. The corin gene product containing the T555I and Q568P mutations has significantly reduced natriuretic peptide processing capacity.

Endothelial nitric oxide synthase (NOS3) polymorphisms in African Americans with heart failure: results from the A-HeFT trial.

Background: Genetic heterogeneity at the endothelial nitric oxide synthase (NOS3) locus influences heart failure outcomes. The prevalence of NOS3 variants differs in black and white cohorts, but the impact of these differences is unknown.

Methods And Results: Subjects (n = 352) in the Genetic Risk Assessment of Heart Failure (GRAHF) substudy of the African-American Heart Failure Trial were genotyped for NOS3 polymorphisms: -786 T/C promoter, intron 4a/4b, and Glu298Asp and allele frequencies and compared with a white heart failure cohort.

Exploring the potential synergistic action of spironolactone on nitric oxide-enhancing therapy: insights from the African-American Heart Failure Trial.

Background: To investigate if treatment with an aldosterone antagonist affects the outcomes of treatment by fixed dose combination of isosorbide dinitrate/hydralazine (FDC I/H) or placebo in black heart failure (HF) patients treated with contemporary HF medications. In the African-American Heart Failure Trial (A-HeFT), FDC I/H was effective in reducing mortality and improving event-free survival. The beneficial effects of aldosterone antagonist (spironolactone [SP]), however have not been adequately assessed in black patients with or without the use of FDC I/H.

Effects of ACE inhibitors or beta-blockers in patients treated with the fixed-dose combination of isosorbide dinitrate/hydralazine in the African-American Heart Failure Trial.

Background: In the A-HeFT (African-American Heart Failure Trial), treatment of African-American patients with New York Heart Association (NYHA) class III/IV heart failure (HF) with fixed-dose combination (FDC) of isosorbide dinitrate/hydralazine (I/H) reduced mortality and morbidity and improved patient reported functional status compared with standard therapy alone.

Objective: To examine the benefit of FDC I/H in subgroups based on baseline drug therapy and to investigate whether ACE inhibitors and/or angiotensin receptor antagonists (angiotensin receptor blockers) [ARBs] or beta-adrenoceptor antagonists (beta-blockers) provided additional benefit in FDC I/H-treated African-American patients with HF.

Study Design: The A-HeFT was a double-blind, placebo-controlled study enrolling 1050 patients stabilized on optimal HF therapies and with NYHA class III/IV HF with systolic dysfunction conducted during the years 2001-4 with up to 18 months follow-up.

Lack of bioequivalence between different formulations of isosorbide dinitrate and hydralazine and the fixed-dose combination of isosorbide dinitrate/hydralazine: the V-HeFT paradox.

Objective: To investigate whether the apparent discrepancy between the efficacy of the combination of isosorbide dinitrate (ISDN) and hydralazine demonstrated in the first V-HeFT trial (V-HeFT I) and that in V-HeFT II could be explained by pharmacokinetic differences in the study drug formulations, and to compare the pharmacokinetic profile of the fixed-dose combination of ISDN/hydralazine (FDC ISDN/HYD; BiDil) formulation used in A-HeFT with that of the V-HeFT study drug formulations.

Study Participants And Methods: A bioequivalence study was performed (n = 18-19 per group) comparing the ISDN and hydralazine formulations used in V-HeFT I, V-HeFT II and A-HeFT in healthy volunteer men and women aged 18-40 years. In phase A of the study, subjects received a reference solution of hydralazine hydrochloride/ISDN (37.

Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial).

The benefits of fixed-dose combination isosorbide dinitrate plus hydralazine (ID/H) in African-Americans with heart failure (HF) were established by the African-American Heart Failure Trial (A-HeFT), which was terminated early because of a significant survival benefit of ID/H. The Extension to A-HeFT trial (X-A-HeFT), designed to make ID/H available for ethical reasons after A-HeFT termination, afforded an opportunity to further observe responsiveness and compliance with ID/H. In total 198 patients completing the A-HeFT took ID/H for an additional 209 +/- 116 days.

Isosorbide dinitrate and hydralazine in a fixed-dose combination produces further regression of left ventricular remodeling in a well-treated black population with heart failure: results from A-HeFT.

Background: Isosorbide dinitrate combined with hydralazine therapy compared with placebo in patients with heart failure resulted in a sustained increase in left ventricular (LV) ejection fraction (EF) indicative of regression of LV remodeling in the first Vasodilator-Heart Failure Trial (V-HeFT-I) in patients receiving only digoxin and diuretic. In the African-American Heart Failure Trial (A-HeFT) a fixed-dose combination resulted in a 43% reduction in mortality in 1050 black patients with heart failure already treated with recommended neurohormonal inhibiting drugs. Whether the fixed-dose combination produces a further regression of LV remodeling when added to renin-angiotensin and sympathetic inhibitors has not been documented.

Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial.

Background: We previously reported that the fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride (FDC I/H) significantly decreased the risk of all-cause death and first hospitalization for heart failure (HF) and improved quality of life in patients with New York Heart Association class III or IV heart failure in the African-American Heart Failure Trial (A-HeFT). The current analyses further define the effect of FDC I/H on the timing of event-free survival (mortality or first hospitalization for HF) and time to first hospitalization for HF, as well as effects by subgroups and effects on cause-specific mortality.

Methods And Results: Kaplan-Meier analyses of the 1050 A-HeFT patients on standard neurohormonal blockade demonstrated that FDC I/H produced a 37% improvement in event-free survival (P<0.

Influence of blood pressure on the effectiveness of a fixed-dose combination of isosorbide dinitrate and hydralazine in the African-American Heart Failure Trial.

Objectives: This study sought to assess the effect of baseline systolic blood pressure (SBP) and changes in SBP on the effectiveness of treatment with fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) in patients with heart failure (HF).

Background: Low SBP is a risk factor for adverse outcomes in patients with HF. However, FDC I/H lowered SBP in the A-HeFT (African-American Heart Failure Trial) and yet prolonged survival.