A prospective, multicentre, randomized, controlled clinical investigation of dermagraft in patients with venous leg ulcers.

摘要

Venous ulcers are the most prevalent form of chronic wounds in the western world and affect approximately 0.2% to 1.3% of the adult population. The gold standard of treatment of venous ulcers is compression therapy in addition to good wound care, maintaining a moist wound environment and infection control. Despite the best care provided by a wide variety of practitioners, complete healing of these ulcers often remains an elusive goal. Tissue engineering offers the ability to replace the damaged or destroyed dermis of a patient suffering an ulcer. Dermagraft is a manufactured living human dermal implant capable of delivering normal matrix proteins and growth factors which, even under the best conditions, venous ulcer patients would be unable to produce themselves. This study which is part of a multicenter, prospective, randomized clinical trial evaluated the safety and efficacy of dermagraft with compression in accelerating the healing of venous ulcers. This 24 week study was conducted in several centers in USA and UK. We report the results of 16 patients (7 females and 9 males) from our site at Boston University Department of Dermatology. All subjects received weekly multi-layer compression therapy and wound care. Nine of the subjects were treated with 4 pieces of dermagraft, applied at weeks 0, 1, 4 and 8. The mean initial ulcer size in the control group was 8.96 cm2 versus 10.94 cm2 in the dermagraft group. The mean healing rate of ulcers in the control group was 0.085 cm/week and in the dermagraft group 0.054 cm/week. In contrast to our results, previous dermagraft studies on diabetic foot ulcers showed accelerated healing. Therefore our results should be interpreted with caution pending results of the entire multi-center study to elaborate on why results may be poor. In Future studies on venous ulcers more frequent applications of dermagraft are required (8 pieces weekly) and bacterial burden should be measured by quantitative bacteriology in all patients who are going to receive dermagraft.