Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers

Gentzkow, Gary D.; Iwasaki, Scott; Hershon, Kenneth S.; Mengel, Marvin; Prendergast, J. Joseph; Ricotta, John J.; Steed, David P; Lipkin, Scott

doi:10.2337/diacare.19.4.350

Cited by 369 publications

(225 citation statements)

References 9 publications

(12 reference statements)

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“…Due in part to increased emphasis on evidence-based medicine, there has been greater standardization in treatment strategies and in what constitutes effective conventional therapy Falanga, 2000). Also, a number of new therapies, including the use of recombinant growth factors (Steed, 1995;Robson et al, 1998Robson et al, , 2001Smiell et al, 1999) and bioengineered skin, (Gentzkow et al, 1996;Bowering, 1998;Falanga et al, 1998;Falanga and Sabolinski, 1999) have been tested successfully in clinical trials. However, in spite of this substantial progress in how chronic wounds are treated, there remains a great need for accelerating their healing and for preventing recurrences.…”

mentioning

confidence: 99%

Fibroblasts from chronic wounds show altered TGF‐β‐signaling and decreased TGF‐β Type II Receptor expression

Kim

Park

et al. 2003

Journal Cellular Physiology

170

128

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Chronic wounds are characterized by failure to heal in a defined time frame. However, the pathogenic steps leading from the etiological factors to failure to heal are unknown. Recently, increasing evidence suggests that resident cells in chronic wounds display a number of critical abnormalities, including senescence and unresponsiveness to the stimulatory action of transforming growth factor-b1 (TGF-b1). In this study, we have determined some of the mechanisms that might be responsible for unresponsiveness to TGF-b1. Using Northern analysis and affinity labeling, we show that venous ulcer fibroblasts have decreased TGF-b Type II receptor expression. This finding is not the result of genetic mutation, as shown by experiments with Type II receptor satellite instability. Decreased Type II receptor expression was accompanied by failure of ulcer fibroblasts to phosphorylate Smad 2, Smad 3, and p42/44 mitogen activating protein kinase (MAPK), and was associated with a slower proliferative rate in response to TGF-b1. We conclude that venous ulcer fibroblasts show decreased Type II receptor expression and display abnormalities in the downstream signaling pathway involving MAPK and the early Smad pathway. These findings suggest ways to address and treat the abnormal cellular phenotype of cells in chronic wounds.

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mentioning

confidence: 99%

Fibroblasts from chronic wounds show altered TGF‐β‐signaling and decreased TGF‐β Type II Receptor expression

Kim

Park

et al. 2003

Journal Cellular Physiology

170

128

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“…The 12 week healing rate in both intervention and control groups were higher in the study of fibroblast/keratinocyte co-culture (56% and 38%, respectively) [12] than those reported for dermal fibroblast culture [69][70][71]. The difference between intervention and control groups was significant.…”

Section: Fibroblast/keratinocyte Co-culturementioning

confidence: 43%

“…One dose-ranging study [69] reported that weekly applications of dermal fibroblast culture improved healing of plantar non-ischaemic ulcers by 12 weeks, when the highest dose was compared with saline-moistened gauze.…”

Section: Dermal Fibroblast Culturementioning

confidence: 99%

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes

Hinchliffe

Valk

Apelqvist

et al. 2008

Diabetes Metab. Res. Rev.

203

132

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SummaryThe outcome of management of diabetic foot ulcers is poor and there is uncertainty concerning optimal approaches to management. We have undertaken a systematic review to identify interventions for which there is evidence of effectiveness. A search was made for reports of the effectiveness of interventions assessed in terms of healing, ulcer area or amputation in controlled clinical studies published prior to December 2006. Methodological quality of selected studies was independently assessed by two reviewers using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Selected studies fell into the following categories: sharp debridement and larvae; antiseptics and dressings; chronic wound resection; hyperbaric oxygen (HBO); reduction of tissue oedema; skin grafts; electrical and magnetic stimulation and ultrasound. Heterogeneity of studies prevented pooled analysis of results. Of the 2251 papers identified, 60 were selected for grading following full text review. Some evidence was found to support hydrogels as desloughing agents and to suggest that a systemic (HBO) therapy may be effective. Topical negative pressure (TNP) may promote healing of post-operative wounds, and resection of neuropathic plantar ulcers may be beneficial. More information was needed to confirm the effectiveness and cost-effectiveness of these and other interventions. No data were found to justify the use of any other topically applied product or dressing, including those with antiseptic properties. Further evidence to substantiate the effect of interventions designed to enhance the healing of chronic ulcers is urgently needed. Until such evidence is available from robust trials, there is limited justification for the use of more expensive treatments and dressings.

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“…Experts highlight the importance of patient adherence to off-loading in the healing of diabetic foot ulcers. 5 The use of mobile technologies to support health behavior interventions (mHealth) is expanding rapidly as a means to improve monitoring of chronic diseases and adherence to healthy behaviors. The use of mHealth to monitor DFU offloading and alerting, with bidirectional feedback between patients and providers has the potential to improve the outcome from DFU treatment.…”

Section: Symposiummentioning

confidence: 99%

Real-Time Smart Textile-Based System to Monitor Pressure Offloading of Diabetic Foot Ulcers

Raviglione

Reif²,

Macagno³

et al. 2017

J Diabetes Sci Technol

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Background: The lifetime risk of developing a diabetic foot ulcer (DFU) is at least 25%. A DFU carries a 50% risk for infection and at least 20% of those receive some form of amputation. The most significant parameter that prevents or delays ulcer healing is high plantar pressure. To improve the patient's healing process, the DFU's plantar pressure should remain cumulatively low. Therefore, a tool that continuously measures the DFU loading, and provides real-time feedback can improve the healing outcome. Methods:We report the development of a system capable of continuously measuring the pressure, which could have applications to monitor DFU. The system contains a textile pressure sensor attached to a stretchable band, hardware that collects data and transmits them via Bluetooth to a phone, an app that gathers the data and stores them in the cloud, and a web dashboard that displays the data to the clinician. The sensor was characterized in vitro using the system, and the webdashboard was developed and tested on simulated patient data. Results:We demonstrate the feasibility of developing the system and characterize the pressure response of the device. As a result, we demonstrate a viable method for monitoring DFU off-loading in real time. Conclusions:The presented study demonstrates the feasibility to develop a simple, modular wearable system that opens up new possibilities for diabetic foot ulcer care by providing a way of monitoring the pressure under the ulcer in real time.

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Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers

Abstract: Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.

Cited by 369 publications

References 9 publications

Fibroblasts from chronic wounds show altered TGF‐β‐signaling and decreased TGF‐β Type II Receptor expression

Fibroblasts from chronic wounds show altered TGF‐β‐signaling and decreased TGF‐β Type II Receptor expression

A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes

Real-Time Smart Textile-Based System to Monitor Pressure Offloading of Diabetic Foot Ulcers

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