HYAFF 11-Based Autologous Dermal and Epidermal Grafts in the Treatment of Noninfected Diabetic Plantar and Dorsal Foot Ulcers

Abstract

OBJECTIVE -To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS -A total of 79 patients with diabetic dorsal(n ϭ 37) or plantar (n ϭ 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n ϭ 36) or the treatment group with autologous tissue-engineered grafts (n ϭ 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events.RESULTS -Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P ϭ 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P ϭ 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P ϭ 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments.CONCLUSIONS -The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total offloading cast is not recommended and only a less effective off-loading device can be applied. Diabetes Care 26:2853-2859, 2003T he current standard treatment for foot ulcers consists of debridement, treatment of infection, pressure relief, and arterial revascularization, if required (1). The risk of infection to the deep tissues and bone structures depends on how long the skin lesion remains unhealed. Pressure off-loading has been demonstrated to be of paramount importance in the healing of plantar neuropathic ulcers in short amounts of time (2,3). There are many reports of high percentage rates of plantar ulcer healing in 6 -10 weeks under a total contact cast (2-9). This technique of pressure relief is now widely recognized as the "gold standard" in diabetic foot ulcer care in terms of quality of pressure off-loading and time to healing (10).In the last few years the use of modern dressing technology has opened the way to a more physiological approach to the repair process, providing an optimal, moist wound environment and good control of exudate. Even so, the use of nonadhesive paraffin-impregnated dressings is currently considered a standard care measure. Only very recently have allogenic skin substitutes been made available through tissue engineering techniques, thus ...

High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study

“…Examples include plantar pressure measurements [12], insoles for the prevention of plantar forefoot and midfoot ulcers [27], and total contact casting [14]. There are very few studies on the management of nonplantar ulcers, despite the fact that healing rates might be lower in dorsal compared with plantar ulcers [28]. Studies on the treatment of PAD in diabetic foot disease are also scarce, and many questions remain to be answered.…”

Immobiliziruyushchaya razgruzochnaya povyazka (Total Contact Cast) v lechenii troficheskikh yazv u bol'nykh sakharnym diabetom

“…Среднее время заживления язв, по данным об зора 18 исследований [12], составляет 36-45 дней. Успешность лечения (число заживших язв) колеб лется от 50% за 30 дней [4] до 88% за 44 дня [8] и даже до 100% за 49 дней. Последний результат по лучен в работе [10].…”

“…Аналогичные результаты показало сходное по дизайну рандо мизированное исследование [4]. в котором эффективность полу жесткой иммобилизации голени и стопы с использованием Softcast сопоставлялась с ношением ортопедической обуви.…”

“…новые трофические язвы), равно как и другие осложнения, встречаются редко. В ряде работ [4,6] с небольшим числом (26 и 16) боль ных осложнений не отмечено вообще.…”

Chronic wound healing by fetal cell therapy may be explained by differential gene profiling observed in fetal versus old skin cells

“…Autologous skin fibroblasts and substitutes of various nature have been used on leg ulcers to date (Limat et al, 1996;Uccioli, 2003;Caravaggi et al, 2003;Cavallini, 2007) with different degrees of efficiency. Major drawbacks are that production time is long since patient tissues are necessary for processing.…”