Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived Dermis

Hanft, Jason R.; Surprenant, Maria S.

doi:10.1097/00129334-200109000-00020

Cited by 14 publications

(20 citation statements)

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“…Statistical analysis of the data indicated that the probability that Dermagraft provides a treatment benefit was 98.4%. These findings are consistent with other studies showing that patients with diabetic foot ulcers had better healing following Dermagraft treatment compared with control treatment even over a 6-month follow-up (11,12).…”

Section: Safetysupporting

confidence: 93%

The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers

Marston

Hanft

Norwood³

et al. 2003

Diabetes Care

629

404

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OBJECTIVE -To determine if a human fibroblast-derived dermal substitute could promote the healing of diabetic foot ulcers. RESEARCH DESIGN AND METHODS-A randomized, controlled, multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks. Patients were randomized to either the Dermagraft treatment group or control (conventional therapy). Except for the application of Dermagraft, treatment of study ulcers was identical for patients in both groups. All patients received pressurereducing footwear and were allowed to be ambulatory during the study.RESULTS -The results demonstrated that patients with chronic diabetic foot ulcers of Ͼ6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone. With regard to complete wound closure by week 12, 30.0% (39 of 130) of Dermagraft patients healed compared with 18.3% (21 of 115) of control patients (P ϭ 0.023). The overall incidence of adverse events was similar for both the Dermagraft and control groups, but the Dermagraft group experienced significantly fewer ulcerrelated adverse events.CONCLUSIONS -The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers.

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Section: Safetysupporting

confidence: 93%

The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers

Marston

Hanft

Norwood³

et al. 2003

Diabetes Care

629

404

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show abstract

“…Dermagraft and Apligraf have been used as a therapeutic modality in chronic wounds. While permanent engraftment of the allogeneic fibroblasts is questionable [Griffiths et al, 2004], stimulation of wound repair seems possible, and various studies on chronic wounds have demonstrated that this dermal substitute enhances healing [Curran et al, 2002;Hanft et al, 2003;Marston et al, 2003]. In contrast to the favorable results in chronic wounds, application of the allogeneic product Dermagraft showed a reduced take rate of a simultaneously applied skin graft in full-thickness burn wounds [Hansbrough et al, 1992].…”

Section: Implication For Therapeutic Skin Engineeringmentioning

confidence: 99%

Diversity of Fibroblasts – A Review on Implications for Skin Tissue Engineering

Nolte

Rennekampff

et al. 2007

Cells Tissues Organs

148

112

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Enormous advances in the development of skin substitutes have occurred in the past 3 decades. Major obstacles yet to be overcome in the quest for an optimal skin substitute include controlling scar formation, contraction and the loss of adnexal structures. Mesenchyme-derived signals are essential for epithelial proliferation, skin morphogenesis, homeostasis and differentiation. Having previously shown that fibroblasts differentiate along a lineage from highly proliferative progenitor fibroblasts with characteristic spindle-shaped appearance to differentiated postmitotic polygonal fibrocytes, we have now established that the different subsets of fibroblasts exert significantly different patterns of cytokine release and that the highest levels of keratinocyte growth factor and transforming growth factor-β₁ expression result from differentiated fibroblasts. Coculture studies with keratinocytes reveal that postmitotic fibroblasts stimulate keratinocyte proliferation to a greater extent than progenitor fibroblasts. Acellular and fibroblast-seeded dermal substitutes have been shown to improve scarring and contraction in animal studies, the latter substitutes yielding the most favorable results. Fibroblasts from different body sites display different functional properties which may affect their suitability for dermal substitutes. Future in vivo human studies in tissue-engineered dermal substitutes will likely focus on fibroblast-seeded lattices and the impact of fibroblast subpopulations and bone marrow-derived mesenchymal stem cells on dermal regeneration.

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“…Wounds closed significantly faster in patients treated with Dermagraft [139] A randomized, single-blind DOLCE trial compared the differences among acellular matrices (Oasis), cellular matrices (Dermagraf), and standard of care in the treatment of diabetic foot ulcers using the primary outcome of complete wound closure by 12 weeks [140] A multicenter clinical trial of Dermagraft in the treatment of diabetic foot ulcers in 62 patients after sharp debridement was performed. Patients received dressing changes with saline gauze or polyurethane foam dressings weekly.…”

Section: Diabetic Foot Ulcersmentioning

confidence: 99%

Skin Tissue-Engineering Constructs and Stem Cells Application for the Skin Equivalents Creation (Review)

Meleshina¹,

Bystrova²,

Rogovaya³

et al. 2017

Sovrem Tehnol Med

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Development and introduction of new biotechnological analogues (equivalents) of tissues and organs into clinical practice, such as human skin equivalents (SE), designed for temporal or permanent replacement of damaged or destroyed tissue, remains an urgent problem of regenerative medicine. Currently, full-thickness SE as well as separate skin layers, which include living cells of different types, are being created and investigated. Since the ideal skin substitutes have not been created, the efforts of researchers in many countries are aimed at solving this problem.In our review, we present a comparative analysis of existing SE, both commercial and those being at the stage of preclinical study, analyze their structure and feasibility of application for solving experimental and clinical tasks. Characteristics of the three main variants of SE have also been considered. Examples of stem cell application for creation of skin equivalents have been given. The main advantages of using stem cells as a cell component of skin equivalents have been described.

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Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived Dermis

Cited by 14 publications

References 0 publications

The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers

The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers

Diversity of Fibroblasts – A Review on Implications for Skin Tissue Engineering

Skin Tissue-Engineering Constructs and Stem Cells Application for the Skin Equivalents Creation (Review)

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