A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis

Caputo, Wayne J; Vaquero, Carina; Monterosa, Alexis; Monterosa, Patricia; Johnson, Edward M.; Beggs, Donald J; Fahoury, George

doi:10.1111/wrr.12456

Cited by 35 publications

(26 citation statements)

References 39 publications

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“…In addition, Theraskin is not indicated for ulcers with severe infection including osteomyelitis. Aside from the present study, successful use of cUC in treating complex DFUs with osteomyelitis has been reported in two retrospective studies . In the first study, 26 of 33 (79%) wounds achieved complete wound closure in 16 ± 9.3 (range: 4–44) weeks with 1.2 ± 0.4 cUC applications.…”

Section: Discussionsupporting

confidence: 53%

“…In comparison with acellular dermal matrix where there was an equal amount of cellular ingrowth, there was decreased acute inflammation and more organized cellular ingrowth of epidermal and meningeal cells in the human cUC . Preliminary studies using the commercially available UC product NEOX™ CORD 1K (Amniox Medical, Inc., Miami, FL) further suggest cUC is safe and useful in promoting healing of complex foot ulcers with osteomyelitis, with healing rates reported from 79 to 100% when combined with negative pressure therapy . TTAX01, an investigation biologic form of the cUC made under Good Manufacturing Practices with additional validations and potency measurements, also contains these potentially beneficial properties.…”

Section: Introductionmentioning

confidence: 99%

“…32 Preliminary studies using the commercially available UC product NEOX™ CORD 1K (Amniox Medical, Inc., Miami, FL) further suggest cUC is safe and useful in promoting healing of complex foot ulcers with osteomyelitis, with healing rates reported from 79 to 100% when combined with negative pressure therapy. 33,34 TTAX01, an investigation biologic form of the cUC made under Good Manufacturing Practices with additional validations and potency measurements, also contains these potentially beneficial properties. This open-label pilot study was designed to estimate the efficacy of TTAX01 plus standard care (SC) in achieving complete wound closure of complex nonhealing DFU.…”

Section: Introductionmentioning

confidence: 99%

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An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

Marston

Lantis

et al. 2019

Wound Repair Regeneration

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Clinical trials of potential new therapies for diabetic foot ulcers rarely enroll patients whose wounds extend to muscle, fascia, or bone with clinical and radiographic evidence of underlying osteomyelitis. An open‐label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2–47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0–9.6) cm2. Aggressive surgical debridement at baseline resulted in 17 minor amputations and an increase in mean wound area to 7.4 ± 5.8 (range: 1.1–28.6) cm2. All subjects were placed on systemic antibiotics for at least 6 weeks in conjunction with baseline application of TTAX01. Repeat applications were made at no less than 4‐week intervals over the 16‐week trial. Initial closure occurred in 18 of 32 (56%) wounds, with 16 (50%) of these having confirmed closure in 16 weeks with a median of one‐product application. Cases with biopsy confirmed osteomyelitis (n = 20) showed initial closure in 12 (60%) wounds and confirmed closure in 10 (50%) wounds. Four of the five ulcers presenting as recurrences experienced confirmed closure. Mean overall time to healing was 12.8 ± 4.3 weeks. Mean wound area reduction from baseline was 91% for all wounds. Of the 16 wounds without confirmed closure during the 16‐week treatment period, five (31.3%) achieved 99–100% wound area reduction by their final visit. The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis; however, there were no major amputations.

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Section: Discussionsupporting

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

Marston

Lantis

et al. 2019

Wound Repair Regeneration

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“…Small retrospective studies show that it may be helpful in wound healing, but RCTs are warranted to evaluate its true efficacy. 82,83 Energy-based therapies Energy-based therapies employ technology to externally stimulate growth in wounds. Modalities currently being studied include electrical stimulation, shockwave therapy, electromagnetic therapy, laser therapy, and phototherapy.…”

Section: Skin Grafts and Bioengineered Skinmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

616

403

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Diabetic foot ulcers (DFUs) are a serious complication of diabetes that results in significant morbidity and mortality. Mortality rates associated with the development of a DFU are estimated to be 5% in the first 12 months, and 5-year morality rates have been estimated at 42%. The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. These practices are best coordinated by a multidisciplinary diabetic foot wound clinic. Even with this comprehensive approach, there is still room for improvement in DFU outcomes. Several adjuvant therapies have been studied to reduce DFU healing times and amputation rates. We reviewed the rationale and guidelines for current standard of care practices and reviewed the evidence for the efficacy of adjuvant agents. The adjuvant therapies reviewed include the following categories: nonsurgical debridement agents, dressings and topical agents, oxygen therapies, negative pressure wound therapy, acellular bioproducts, human growth factors, energy-based therapies, and systemic therapies. Many of these agents have been found to be beneficial in improving wound healing rates, although a large proportion of the data are small, randomized controlled trials with high risks of bias.

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“…A third retrospective study examined the efficacy and safety of NEOX cryopreserved umbilical cord in treatment of complex lower extremity ulcers involving exposed bone, muscle, tendon, or joint capsule within the background of underlying osteomyelitis (22). Seventy-eight percent of these complex wounds achieved complete closure, with a median time-to-heal of 16 weeks using an average of 1.24 applications of NEOX Wound Allograft ( Table 1).…”

Section: Amniotic and Placental Membranesmentioning

confidence: 99%

An update and review of cell-based wound dressings and their integration into clinical practice

Pourmoussa¹,

Gardner²,

Johnson³

et al. 2016

Ann. Transl. Med.

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Chronic wounds affect over 4 million individuals and pose a significant burden to the US healthcare system. Diabetes, venous stasis, radiation or paralysis are common risk factors for chronic wounds. Unfortunately, the current standard of care (SOC) has a high relapse rate and these wounds continue to adversely affect patients' quality of life. Fortunately, advances in tissue engineering have allowed for the development of cell-based wound dressings that promote wound healing by improving cell migration and differentiation. As the available options continue to increase in quantity and quality, physicians should have a user-friendly guide to reference when deciding which dressing to use. The objective of this review is to identify the currently available biologic dressings, describe their indications, and provide a framework for integration into clinical practice. This review included 53 studies consisting of prospective and retrospective cohorts as well as several randomized control trials. Three general categories of cell-based biologic dressings were identified and nine brands were included. Cell-based biologic dressings have shown efficacy in a broad range of scenarios, and studies examining their efficacy have improved our understanding of the pathophysiology of chronic wounds. Amniotic and placental membranes have the widest scope and can be used to treat all subtypes of chronic wounds. Human skin allografts and bioengineered skin substitutes can be used for chronic ulcers but generally require a vascularized wound bed. Autologous platelet rich plasma (PRP) has shown promise in venous stasis ulcers and decubitus ulcers that have failed conventional treatment. Overall, more research is necessary to determine if these novel therapeutic options will change the current SOC, but current studies demonstrate encouraging results in the treatment of chronic wounds.

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A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis

Cited by 35 publications

References 39 publications

An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis

Update on management of diabetic foot ulcers

An update and review of cell-based wound dressings and their integration into clinical practice

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