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Objective: To quantify race, sex, comorbidities, Medicaid status, and compare health outcomes for Medicare-only versus Medicare/Medicaid dual-enrolees who developed a hard-to-heal venous leg ulcer (VLU). Method: Medicare Limited Data Standard analytic hospital inpatient and outpatient department files were used to follow episodes of medical care for a VLU from 1 October 2015–2 October 2019. In an earlier study, patients diagnosed concurrently with chronic venous insufficiency and a VLU were propensity-matched. In this current work, cohorts were split into patients enrolled in Medicare-only and those enrolled in Medicare and Medicaid (dual-enrolees). Treatment methods were compared and the most commonly used cellular, acellular and matrix-like product (CAMP) among Medicare beneficiaries—dehydrated human amnion chorion membrane (DHACM)—was evaluated. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs and outcomes such as time to ulcer closure, rates of complications and hospital usage rates. Quality of life (QoL) metrics, such as pain and time to VLU closure, were compared across the groups. Results: Of the 555,284 Medicare beneficiaries evaluated in this analysis, 27% were Medicare/Medicaid dual-enrolees and 73% were Medicare-only enrolees. To qualify for Medicaid, patient income had to be ≤133% of the federal poverty level. Only 3% of Medicare-only patients and 6% of dual-enrolees had an Advantage plan, a lower rate than the general Medicare population. Dual-enrolees, compared to those covered by Medicare-only, demonstrated: a Charlson Comorbidity Index (CCI) score one point greater (p<0.0001); a higher percentage (16%) of patients from minority ethnic backgrounds; and significantly higher rates of emergency department visits (p<0.0001) and cellulitis (p=0.034). Dual-enrolees who received early and regularly applied CAMPs also reduced their treatment time by 21 days (p=0.0027), all of which can impact costs. Conclusion: The socioeconomic status of dual-enrolees included near poverty status, a higher percentage of patients from a minority ethnic background, and high rates of comorbidities compared to their Medicare-only counterparts. The VLUs of dual-enrolees took longer to close, developed more complications, and used significantly more hospital resources and expenses. Outcomes significantly improved when VLU episodes were treated with a CAMP, such as DHACM, while following parameters for use. Socioeconomic variables are associated with poor outcomes for patients with hard-to-heal (chronic) wounds. This should be tracked to find cost-effective interventions throughout their journey to provide equitable care and ensure they are not left behind. Greater access for dual-enrolees to CAMPs has the potential to improve clinical outcomes and patient QoL, while concomitantly reducing overall healthcare expenditure. [ABSTRACT FROM AUTHOR]

Early indicators of healing provide valuable information on the potential benefit of treatment. In patients with hard-to-heal (chronic) diabetic foot ulcers (DFUs), timely intervention is critical. Ulcers that fail to show measurable progress within four weeks of treatment are considered recalcitrant. These ulcers increase the risk of soft tissue infection, osteomyelitis and lower extremity amputation. A prognostic indicator or surrogate marker allows for rapid evaluation of treatment efficacy and safety. An inverse correlation between a percentage area reduction (PAR) of ≤50% at week 4 and complete healing by week 12 has been previously established; however, the data were derived from a standard of care (SoC) arm of clinical trials that are over a decade old. In this post hoc analysis, data from a large multicentre prospective randomised controlled trial were reviewed to assess PAR at week 4 as a prognostic indicator in patients treated with SoC. Overall, 65.4% (17/26) of patients with PAR >50% at week 4 achieved complete closure at week 12. The receiver operating characteristic (ROC) curve for area reduction by week 4 showed strong discrimination for predicting non-healing (area under the ROC curve: 0.92; p<0.001; positive predictive value: 70.6%; negative predictive value: 87.2%). These findings are consistent with previous studies and support the use of four-week PAR as a prognostic indicator. [ABSTRACT FROM AUTHOR]

We assessed the safety and efficacy of Formulated Collagen Gel (FCG) alone and with Ad5PDGF-B (GAM501) compared with Standard of Care (SOC) in patients with 1.5-10.0 cm(2) chronic diabetic neuropathic foot ulcers that healed

Objective: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). Method: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30–45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015–2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. Results: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. Conclusion: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. Declaration of interest: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US. [ABSTRACT FROM AUTHOR]

In the wake of the coronavirus pandemic, the critical limb ischemia (CLI) Global Society aims to develop improved clinical guidance that will inform better care standards to reduce tissue loss and amputations during and following the new SARS‐CoV‐2 era. This will include developing standards of practice, improve gaps in care, and design improved research protocols to study new chronic limb‐threatening ischemia treatment and diagnostic options. Following a round table discussion that identified hypotheses and suppositions the wound care community had during the SARS‐CoV‐2 pandemic, the CLI Global Society undertook a critical review of literature using PubMed to confirm or rebut these hypotheses, identify knowledge gaps, and analyse the findings in terms of what in wound care has changed due to the pandemic and what wound care providers need to do differently as a result of these changes. Evidence was graded using the Oxford Centre for Evidence‐Based Medicine scheme. The majority of hypotheses and related suppositions were confirmed, but there is noticeable heterogeneity, so the experiences reported herein are not universal for wound care providers and centres. Moreover, the effects of the dynamic pandemic vary over time in geographic areas. Wound care will unlikely return to prepandemic practices. Importantly, Levels 2–5 evidence reveals a paradigm shift in wound care towards a hybrid telemedicine and home healthcare model to keep patients at home to minimize the number of in‐person visits at clinics and hospitalizations, with the exception of severe cases such as chronic limb‐threatening ischemia. The use of telemedicine and home care will likely continue and improve in the postpandemic era. [ABSTRACT FROM AUTHOR]

The 2006 U.S. Food and Drug Administration Guidance for Industry emphasizes wound closure as the primary outcome for clinical trials in wound healing. Wound care professionals understand that complete wound healing is not always achievable when evaluating new treatments. FDA, Association for the Advancement of Wound Care, and Wound Healing Society are working collaboratively to identify scientifically achievable, clinically relevant, and patient‐centered endpoints with sufficient support to serve as primary outcomes for clinical trials. The Opinion Survey from People with Wounds presented here addresses an important but understudied issue: the gap between clinician, healthcare insurance companies, government agencies, and patient perspectives regarding clinically meaningful and scientifically achievable primary endpoints for wound care. The survey, adapted from the clinician survey with adjustment for health literacy, was pilot tested and revised based on a limited number of patients in a single clinic. After central IRB approval, the on‐line survey was administered in English and Spanish and submitted anonymously to a server with the cooperation of multiple wound clinics and societies. Four hundred and thirty‐eight patients and caregivers from across the United States responded over a 10‐month period. Based on this survey, the most valuable clinical endpoints were reduced infection, recurrence, and amputation. The most valuable quality of life outcomes were increased independence, reduced social isolation, and pain. The top five endpoints in terms of usefulness for measuring clinical trial success were time to heal, wound size, infection, recurrence, and pain. Narrative responses from wound patients emphasized the inability to perform activities of daily living and pain as major factors that impacted their daily lives. Engagement of patients in clinical trials and evaluation of potential treatments is critical to improving wound care. This survey provides insight into the needs of patients with wounds and provides a roadmap for structuring future clinical trials to better meet those needs. [ABSTRACT FROM AUTHOR]