Abstract Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts ( EpiFix ®, MiMedx , Kennesaw, GA ) versus standard care. An IRB ‐approved, prospective, randomised, single‐centre clinical trial performed. Included were patients a ulcer at least 4‐week duration without infection having adequate arterial perfusion. Patients randomised receive care alone or the addition . Wound size reduction and rates complete after...

ABSTRACT This investigation was conducted to determine if a correlation exists between wound healing outcomes and serial debridement in chronic venous leg ulcers (VLUs) diabetic foot (DFUs). We retrospectively analyzed the results from two controlled, prospective, randomized pivotal trials of topical treatments on 366 VLUs 310 DFUs over 12 weeks. Weekly surface area changes following 12‐week closure rates centers patients were evaluated. had significantly higher median reduction clinical...

Abstract A prospective, randomised, controlled, parallel group, multi‐centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment chronic lower extremity diabetic ulcers with either weekly applications Apligraf ® (Organogenesis, Inc., Canton, MA ), EpiFix ( MiMedx Group, Marietta, GA or standard wound care collagen‐alginate dressing. The primary study outcome percent change in complete after 4 and 6 weeks treatment. Secondary outcomes included area...

Abstract Advanced therapies such as bioengineered skin substitutes ( BSS ) and dehydrated human amnion/chorion membrane dHACM have been shown to promote healing of chronic diabetic ulcers. An interim analysis data from 60 patients enrolled in a prospective, randomised, controlled, parallel group, multi‐centre clinical trial showed that EpiFix ®, MiMedx Group Inc., Marietta, GA is superior standard wound care SWC (Apligraf®, Organogenesis, Canton, MA achieving complete closure within 4–6...

The aim of this study is to determine if weekly application dehydrated human amnion/chorion membrane allograft reduce time heal more effectively than biweekly for treatment diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers ≥ 4 weeks duration were included the study. They randomised receive or in addition a non-adherent, moist dressing compressive...

The increased cost and morbidity associated with diabetic foot ulcers (DFUs) place a substantial strain on the entire global healthcare system. In this trial, 24 subjects chronic DFU, Wagner grade 1 (University of Texas 1A), were treated Standard Care (SOC) therapy randomized, one-half to receive advanced high-purity Type-I collagen-based skin substitute (HPTC; manufactured by Encoll Corp., Fremont, CA, USA), other half dehydrated human amnion/chorion membrane (dHACM) or viable cryopreserved...

Background: Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results randomized clinical trial examining efficacy micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as for chronic refractory fasciitis. Methods: An institutional review board–approved, prospective, randomized, single-center was performed. Forty-five patients were receive 2 cc 0.5%...

Background: Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard care (SOC) facilitating wound closure nonhealing DFUs. Methods: Patients with DFUs treated SOC (off-loading, appropriate debridement, moist care) after a 2-week screening period were randomized either or wound-size-specific dHACA...

Abstract Acellular dermal matrices can successfully heal wounds. This study's goal was to compare clinical outcomes of a novel, open‐structure human reticular acellular dermis matrix ( HR‐ADM ) facilitate wound closure in non‐healing diabetic foot ulcers DFUs versus treated with standard care SOC ). Following 2‐week screening period which were offloading and moist care, patients randomised either alone or plus applied weekly for up 12 weeks. At 6 weeks, the primary outcome time, 65% ‐treated...

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients demonstrated the accelerated ability a novel aseptically processed, dehydrated human amnion allograft (dHACA). The goal this study was to report on full trial results 80 where dHACA compared with standard care (SOC) achieving wound closure non-healing DFUs. After 2-week screening period, during which DFUs were unsuccessfully treated SOC, randomised...

Local muscle flaps, pioneered by Ger in the late 1960s, were extensively used for foot and ankle reconstruction until 1970s when, with evolution of microsurgery, microsurgical free flaps became reconstructive method choice. To assess whether current underuse local surgery is justified, authors identified from Georgetown Limb Salvage Registry all patients who underwent 1990 through 1998. By protocol, flap coverage was choice defects exposed tendons, joints, or bone. selected over if defect...

Local muscle flaps, pioneered by Ger in the late 1960s, were extensively used for foot and ankle reconstruction until 1970s when, with evolution of microsurgery, microsurgical free flaps became reconstructive method choice. To assess whether current underuse local surgery is justified, authors identified from Georgetown Limb Salvage Registry all patients who underwent 1990 through 1998. By protocol, flap coverage was choice defects exposed tendons, joints, or bone. always selected over if...

Objective: To evaluate healing of chronic diabetic foot ulcers (DFUs) with use dehydrated human amniotic membrane (dHAM) in patients failing under standard care treatment. Method: The study population was identified from DFUs enrolled a randomised trial comparing the addition dHAM. present included that failed to heal (defined as <50% decrease wound size after 6 weeks, or not completely healed by 12 weeks treatment) care. One week withdrawal trial, these were offered treatment and...

Aseptically processed human reticular acellular dermal matrix (HR‐ADM) has been previously shown to improve wound closure in 40 diabetic patients with non‐healing foot ulcers. The study was extended additional (80 total) validate and extend the original findings. entire cohort of 80 underwent appropriate offloading standard care (SOC) during a 2‐week screening period and, after meeting eligibility criteria, were randomised receive weekly applications HR‐ADM plus SOC or alone for up 12 weeks....

Abstract Diabetic foot ulcers (DFUs) are at risk for detrimental complications even with current, standard of care (SOC) treatments. The primary objective this randomised controlled trial was to compare a unique resorbable glass microfiber matrix (Mirragen; Advanced Wound Matrix [BBGFM]; ETS Care, Rolla, Missouri) compared group (SOC, collagen alginate dressing) 12 weeks. Both groups received diabetic including glucose monitoring, weekly debridements when needed and an offloading device....

Diabetic foot ulcers (DFU) are notoriously slow to heal and even in cases where primary healing is achieved frequently recur. An optimal treatment for DFU would be one that supports both rapid long-term healing. Our purpose evaluate recurrence rates of healed with use dehydrated human amnion/chorion membrane (dHACM). Twenty-two patients chronic the dHACM were eligible inclusion. All had completed a single-center randomized clinical trial comparing over 12 week period versus standard regimen...

Background: An aseptically processed dehydrated human amnion and chorion allograft(dHACA) without terminal sterilization has been shown to improve healing rates in chronic wounds. This randomized controlled trial(RCT) evaluated the safety effectiveness of weekly biweekly applications dHACA plus Standard Care (SOC) compared SOC alone on venous leg ulcers (VLUs). Methods: open-label RCT included patients with VLUs at 8 wound care centers across United States. The primary endpoint was...

Abstract Diabetic foot ulcers (DFUs) pose a significant risk for infection and limb loss. Advanced wound therapies including human skin allografts have shown promise in resolving these challenging wounds. The primary objective of this randomised, prospective study was to compare the response 100 subjects with non‐healing DFUs which 50 were treated cryopreserved bioactive split thickness allograft (BSA) (TheraSkin; Misonix,Inc., Farmingdale, NY) compared standard care (SOC, collagen alginate...

Aseptically processed dehydrated human amnion and chorion allograft (dHACA) (AmnioBand) has shown great promise in the treatment of recalcitrant diabetic foot ulcers (DFUs) when compared with standard wound care but not yet been to any other tissue forms used treating DFUs. The hypothesis was conduct a randomized controlled trial which dHACA one earliest most commonly accepted tissue-engineered skin substitutes (TESS) (Apligraf) nonhealing DFUs over period 12 weeks assess superiority...

Abstract Diabetic foot infections continue to be a major challenge for health care delivery systems. Following encouraging results from pilot study using novel purified reconstituted bilayer matrix (PRBM) treat chronic diabetic ulcers (DFUs), we designed prospective, multi‐centre randomised trial comparing outcomes of PRBM at 12 weeks compared with standard (SOC) collagen alginate dressing. The primary endpoint was percentage wounds closed after weeks. Secondary included assessments...

Abstract Diabetic foot complications that lead to lower extremity amputations pose a significant challenge the entire global health system. In this multicentre clinical trial, 26 patients with chronic Wagner one diabetic ulcers (DFUs) were treated unique human keratin matrix graft applied either weekly or bi‐weekly, in addition standard of care. The hypothesis was bi‐weekly application would be similar application. primary endpoint complete wound closure by 12 weeks, and secondary endpoints...

Diabetic foot complications are increasingly burdensome for patients, clinicians, and society. Development of innovative therapies to support good quality basic care is a priority among those with an interest in this area. One these involves scanning printing tissues match conform defect (so-called 3D printing).A single-arm pilot study ten consecutive patients history chronic diabetic ulcer (DFU), treated autologous minimally manipulated homologous adipose tissue (AMHAT), dispensed by...