Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting.
This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase.
Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up.
These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure. (J Am Podiatr Med Assoc 103(4): 274–280, 2013)
Background: We used a model of lower-extremity ulceration to determine the impact of a podiatric lead limb preservation team on identified relationships among risk factors, predictors of ulceration, amputation, and clinical outcomes of lower-extremity disease in patients with diabetes mellitus.
Methods: A total of 485 patients with diabetes mellitus were randomly selected from the diabetic population and included in this retrospective cohort study. Patients were then stratified into two groups: those who received specialty podiatric medical care and those who did not. Data covering a 5-year period were collected using electronic medical records and chart abstraction to capture detailed treatment characteristics, ulcer status, and surgical outcomes.
Results: Overall, the frequencies of inpatient and outpatient encounters and the durations of hospital stays were significantly greater with increasing wound depth and in the presence of infection. In addition, the overall ulcer incidence was greater in patients with callus (34.3% versus 10.3%, P < .0001) with and without neuropathy (20.4% and 4.1%, P < .0001). Among patients treated in a specialty multidiscipline podiatric medical setting, the proportion of all amputations that were “minor” was significantly increased (33.7% versus 67.3%, P = .0006), and survival was significantly improved (19.5% versus 7.7%, P < .0001).
Conclusions: Early identification of individuals at increased risk for lower-extremity ulceration and subsequent referral for advanced multidiscipline podiatric medical specialty care may decrease rates of ulceration and proximal amputation and improve survival in patients with diabetes mellitus who are at high risk for ulceration and limb loss. (J Am Podiatr Med Assoc 100(4): 235–241, 2010)