PTA as the first choice revascularisation procedure is feasible, safe and effective for limb salvage in a high percentage of diabetic patients. Clinical restenosis was an infrequent event and PTA could successfully be repeated in most cases.
OBJECTIVE -To evaluate the long-term prognosis of critical limb ischemia (CLI) in diabetic patients. CONCLUSIONS -Diabetic patients with CLI have high risks of amputation and death. In a dedicated diabetic foot center, the major amputation, ulcer recurrence, and major contralateral limb amputation rates were low. Coronary artery disease (CAD) is the leading cause of death, and in patients with CAD history the impaired ejection fraction is the major independent prognostic factor.
RESEARCH DESIGN AND METHODS
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 ...
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