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Original Article Plastic and Aesthetic Research

Allogeneic epidermal substitutes in the

treatment of chronic diabetic leg and foot

ulcers

Andrea Marchesi , Marco Brioschi , Pier Camillo Parodi , Matteo Marchesi ,
3
1
1
2
Roberto Brambilla , Luca Vaienti 1
4
1 Department of Plastic and Reconstructive Surgery, IRCCS San Donato Polyclinic, University of Milan, 20097 Milan, Italy.
2 Department of Plastic and Reconstructive Surgery, University of Udine, 33100 Udine, Italy.
3 Department of Biomedical Science for Health, Section of Legal and Insurance Medicine, University of Milan, 20133 Milan, Italy.
4 Wound Care Unit, Zucchi Clinical Institutes, 20052 Monza, Italy.
Address for correspondence: Dr. Andrea Marchesi, Department of Plastic and Reconstructive Surgery, IRCCS San Donato Polyclinic,
University of Milan, Via Morandi, 20097 Milan, Italy. E-mail: ilmarchesiandrea@gmail.com

ABSTRACT
Aim: Diabetic foot ulcers are the most common cause of nontraumatic lower extremity amputations in
the industrialized world. Tissue-engineering products offer a lower extremity salvage strategy when
healing does not proceed according to the standard of care. New allogeneic sheets are available for
the management of diabetic leg and foot ulcers. Methods: The endpoints of this case series study
regard preliminary outcomes of the application of allogeneic keratinocytes composed of benzyl ester of
hyaluronic acid to 16 diabetic foot and leg ulcers in 11 patients with type 2 diabetes mellitus. Results:
Between 21 and 70 days after cellular therapy, 6 out of 16 lesions were completely healed, reducing
the wound dimension by 70% and improving the wound bed score by 52%. Conclusion: The clinical
results of the new allogeneic sheets indicate that allogeneic keratinocytes may represent an effective and
safe therapy for diabetic foot and leg ulcers in the multidisciplinary approach to this diabetes-related
complication.
Key words:
Allogeneic keratinocytes, diabetic ulcer, epidermal substitutes, hyaluronic acid

INTRODUCTION Risk factors for diabetic chronic ulcers include vascular
anomalies, peripheral neuropathy, imbalanced foot
The burden of diabetes‑related complications is an mechanical forces, impaired joint mobility, high
inevitable consequence of the rise in the prevalence of body mass, foot instability, and history of previous
diabetes mellitus worldwide. The lifetime probability of ulceration or amputation. The standard of care for
diabetics to develop a diabetic chronic ulcer is estimated at these wounds, as defined by the International Working
10%–25%. The risk for patients, in particular with type 2 Group on the Diabetic Foot, requires multidisciplinary
[1]
diabetes, of undergoing a lower extremity amputation management including control of systemic glucose,
is 23‑fold higher than that of a nondiabetic. Diabetic extremity vascularization, off‑loading, debridement of
[2]
chronic ulcers definitively represent a significant cause of necrotic tissue, control of local infection, and patient
morbidity, hospitalization, and a huge financial cost. compliance. [3,4]

Access this article online In this holistic approach, for lesions where the healing
Quick Response Code: process is unsatisfactory, and no other underlying cause
Website: exists, there is an increasing need for more effective
www.parjournal.net
therapies that will stimulate healing of diabetic chronic
ulcers. Tissue‑engineered products, especially skin
DOI: substitutes, both cellular and acellular, are emerging as
10.4103/2347-9264.139706 new local therapy for the treatment of nonhealing diabetic
chronic ulcers. [5]

74 Plast Aesthet Res || Vol 1 || Issue 2 || Sep 2014