Faglia E,

No 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 ...

OBJECTIVE -To evaluate and compare the rate of reduction of the surface area of neuropathic plantar ulcers in diabetic patients treated with nonremovable rigidity-differentiated fiberglass off-bearing casts or a cloth shoe with a rigid sole with unloading alkaform insoles. The secondary aim was to evaluate the side effects and degree of patient acceptance of treatment. RESEARCH DESIGN AND METHODS -Fifty diabetic patients with neuropathicplantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Of the 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unloading alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bearing fiberglass cast (cast group). All patients in both study groups returned to the clinic for weekly control visits. Their ulcers were treated with a standard dressing. Tracings of the ulcer area using a transparent dressing were performed on the day of entry to the study and after 30 days of treatment. The presence of new ulcerations caused by the use of the pressure-relief apparatus was recorded. Patient acceptance of the treatment was measured using a visual analog scale.RESULTS -At the end of the treatment period, an 8.3% increase of the ulcer area was observed in two patients in the shoe group, whereas in the cast group, no patient presented an increase. The reduction of the ulcer area was statistically more rapid in the cast group (MannWhitney test, P = 0.0004). Furthermore, the number of ulcers completely healed at the 30-day time point was 13 (50%) in the cast group and 5 (20.8%) in the shoe group (P = 0.03). In both groups, no side effects were recorded. The average score ± SD of patient acceptance was 91.15 ± 9.9 in the shoe group and 88.33 ± 17.3 (NS) in the cast group.CONCLUSIONS -Our study has shown a significant difference in the speed of the reduction of neuropathic plantar ulcers treated with a fiberglass cast compared with a specialized cloth shoe. The use of fiberglass material with variable rigidity has also shown two important results: the elimination of side effects including ulcers caused by the cast, and high patient acceptance. These data show that the use of off-bearing casts made with fiberglass bandages of variable rigidity is the elective treatment of neuropathic plantar ulcers.

In CLI diabetic subjects with ischemic foot ulcer, the vascular involvement is extremely diffuse and particularly severe in tibial arteries, with high prevalence of long occlusions. A new morphologic categorization of these patients is proposed.