Exclusion criteria also included ulcer treatment with normothermic or hyperbaric oxygen therapy concomitant medications such as corticosteroids, immunosuppressive medications, or chemotherapy recombinant or autologous growth factor products skin and dermal substitutes within 30 days of study start or use of any enzymatic debridement treatments. Patients with uncontrolled hyperglycemia (A1C >12%) or inadequate lower extremity perfusion were not enrolled. Patients with recognized active Charcot disease or ulcers resulting from electrical, chemical, or radiation burns and those with collagen vascular disease, ulcer malignancy, untreated osteomyelitis, or cellulitis were excluded from the study. Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen test ≥30 mmHg, ankle-brachial index values ≥0.7 and ≤1.2 with toe pressure ≥30 mmHg, or Doppler arterial waveforms that were triphasic or biphasic at the ankle of the affected leg. The patient population consisted of diabetic adults ≥18 years with a stage 2 or 3 (as defined by Wagner's scale) calcaneal, dorsal, or plantar foot ulcer ≥2 cm 2 in area after debridement ( 13). In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months.ĬONCLUSIONS-NPWT appears to be as safe as and more efficacious than AMWT for the treatment of diabetic foot ulcers. The proportion of home care therapy days to total therapy days for NPWT was 9,471 of 10,579 (89.5%) and 12,210 of 12,810 (95.3%) for AMWT. NPWT patients experienced significantly ( P = 0.035) fewer secondary amputations. The Kaplan-Meier median estimate for 100% ulcer closure was 96 days (95% CI 75.0–114.0) for NPWT and not determinable for AMWT ( P = 0.001). RESULTS-A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73 of 169, 43.2%) than with AMWT (48 of 166, 28.9%) within the 112-day active treatment phase ( P = 0.007). Each study visit included closure assessment by wound examination and tracings. Patients whose wounds achieved ulcer closure were followed at 3 and 9 months. The trial evaluated treatment until day 112 or ulcer closure by any means. Patients were randomly assigned to either NPWT (vacuum-assisted closure) or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. ![]() Complete ulcer closure was defined as skin closure (100% reepithelization) without drainage or dressing requirements. RESEARCH DESIGN AND METHODS-This multicenter randomized controlled trial enrolled 342 patients with a mean age of 58 years 79% were male. OBJECTIVE-The purpose of this study was to evaluate safety and clinical efficacy of negative pressure wound therapy (NPWT) compared with advanced moist wound therapy (AMWT) to treat foot ulcers in diabetic patients.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |