Presently, 18.2 million people in the United States have diabetes mellitus. Reports indicate that 15% of persons with diabetes will develop at least 1 foot ulcer during the course of their lifetime. 1 Foot ulceration is a serious complication of diabetes that leads to more than 70% of diabetes-related lower extremity amputations. 2 The annual Medicare cost for care in patients with diabetes who have foot ulceration is 3 times that of patients with diabetes who do not have an ulceration, with inpatient care accounting for 70% of ulcer care costs. 3 A program that effectively manages foot ulcers and reduces hospital admissions could substantially reduce costs of care in diabetes mellitus.
The Louisiana State University Health Sciences Center (LSUHSC) administers the state’s public hospital system. Located throughout the state, the system’s 9 hospitals are the primary provider of health services to approximately 1 million underinsured, uninsured, and medically underserved residents. Medical care is provided annually to more than 27,000 persons with diabetes, of whom approximately 67% are uninsured, according to statistics provided by the LSUHSC Health Care Services Division. LSUHSC treats a large low-income population with twice the risk for diabetes-related foot complications. A regionally based diabetes foot program (DFP) was established in Baton Rouge, LA, in 1998 to provide specialized diabetes foot care and prevent lower extremity amputations in the Louisiana public hospital system. The DFP has been shown to be effective in healing ulcers and reducing foot-related hospitalizations and lower extremity amputations; it is also cost effective in managing diabetes foot ulcers when compared with standard care in the LSUHSC hospital system. 4–7
Many rural residents are medically under-served as the result of economic and geographic barriers, inhibiting their ability to travel long distances to 1 of the state public hospitals for care. More than 20,000 patients with diabetes who are at risk for foot problems are cared for by the Louisiana hospital system; many live between 50 and 300 miles from the LSUHSC diabetes foot program. These underinsured or uninsured patients lack the finances and the transportation to make regular visits to distant medical facilities.
Limited data on the use of telemedicine in the management of diabetes-related foot ulcerations can be found in the literature. A number of descriptive studies have found store-and-forward digital images, 8–10 video phones using audio and still images, 11–12 and real-time 2-way video 13 as useful approaches in the evaluation, management, and reduction of costs 14 of lower extremity ulcerations. The store-and-forward transmission of digital images and real-time video conferencing may be efficient methods for a home care nurse treating patients with ulcerations because it would allow the nurse to coordinate and track the progress of wound care and expedite surgical referrals to off-site physicians. 10–15
Photographic images are reliable 16 and valid 16–17 tools in the off-site assessment of trunk and lower extremity vascular and pressure ulcers. The validity and reliability of store-and-forward and real-time telemedicine in patients with diabetes-related foot ulcers has not been studied.
The use of real-time, interactive telemedicine consultations between a home health nurse providing wound care and a remote wound care specialist may improve wound care. In a descriptive report of 120 home care medical records of patients with pressure, venous stasis, and diabetic foot ulcers, the number of treatment visits, weeks to healing, wound-related hospitalizations, and wound care costs were lower after implementation of telemedicine consultations. 18 No data in the literature support the effectiveness of real-time interactive video in the management of diabetes-related foot ulcerations.
The purpose of this study was to determine if the telemedicine management of foot ulcerations is medically equivalent to on-site care provided at a diabetes foot program. An additional purpose was to examine whether telemedicine is a feasible way to geographically extend the effectiveness of treating diabetes-related foot ulcerations in a statewide public hospital system.
Healing rates in 20 consecutive diabetes patients treated for neuropathic forefoot ulcerations at the LSUHSC Lallie Kemp Medical Center (LKMC) via telemedicine consultation with the DFP (telemedicine group) were compared with 120 consecutive patients treated on-site only at the DFP (DFP group). The LSUHSC Institutional Review Board approved the study.
The LKMC (Independence, LA) is located in a rural area, approximately 55 miles from the DFP (Baton Rouge, LA). In the telemedicine group, real-time interactive video was used to link a DFP physician and physical therapist with the distant patient and LKMC nurse specialist. The DFP physician established staff privileges at LKMC at the onset of the program.The nurse specialist was certified in wound care and trained in the use of a foot-care decision pathway 19 (algorithm;Figures 1a, 1b, 1c, 1d, 1e) and fabrication of alternative off-loading methods. In the telemedicine group, the nurse specialist used a simple healing shoe with or without an accommodative dressing. More extensive offloading methods were used on-site at the DFP, including a contact cast, walking splint, and an accommodative dressing with a healing shoe. The accommodative dressing and healing shoe have been previously described and shown to be effective. 5
The decision pathway 19 is a set of conditional logic statements that provide a framework to evaluate and manage neuropathic foot problems in a multidisciplinary setting. It approaches management in 5 clinical sub-pathways: injury prevention, warm swollen foot, ulcer, osteomyelitis, and tissue remodeling. The decision pathway assists the clinician in the appropriate use of antibiotics, X-ray, wound care, surgical referral, custom devices to off-load pressure, self-care education, and, after healing, custom-fabricated orthoses and footwear and monitored progressive ambulation. The pathway emphasizes the appropriate use of wound off-loading, shown to be the most effective approach in healing neuropathic foot ulcers. 20–21
With the support of the DFP team via telemedicine, the nurse specialist delivered the majority of ulcer care, including the fabrication of simple off-loading devices. Ten patients in the telemedicine group required a single visit to the DFP for a specialized offloading device beyond the capabilities of the nurse specialist.
Telemedicine consultations were scheduled at a regular time each week and were integrated in the clinical workflow of the DFP. The LKMC nurse specialist completed and faxed an evaluation form to the DFP prior to the telemedicine consultations. The evaluation form included skin condition, wound condition, ulcer/wound grade, risk category, and treatment plan. As part of an ongoing educational and mentoring process, the DFP team used the real-time, interactive telemedicine consultation to assess the nurse specialist’s evaluation for accuracy and for agreement with the published decision pathway.
The telemedicine equipment located at the DFP and LKMC included a Polycom ViewStation video conferencing unit supporting real-time, interactive, full-room video and audio communications, and a 27-inch television monitor for video display and audio reception. In addition, LKMC was equipped with an AMD 2500 handheld camera for real-time transmission of close-up images of the foot and a Canon document camera for real-time transmission of foot X-ray images.
The telemedicine consultations were transmitted via a dedicated T1 line on the LSUHSC telemedicine and distance learning network, which is managed and supported by the Section of Medical Informatics and Telemedicine at LSUHSC in New Orleans. LSUHSC began using distance technologies in 1994 to enhance access to quality care for all residents of Louisiana, especially those in areas of the state that are medically under-served.The program supports real-time and store-and-forward medical and surgical specialty telemedicine services (ie, dermatology, neurology, psychiatry, orthopedics, cardiology, endocrinology, infectious disease) and delivers continuing education content for physicians, nurses, and allied health professionals on a distributed network connecting more than 40 urban and rural end-user sites.
Forefoot ulcer healing was measured in days to closure and percentage of ulcers closed in 12 weeks. Data on wound size was obtained from recordings on a standardized ulcer tracking form located in the patient’s medical record. If multiple forefoot ulcerations were present, only the largest ulcer was used for analysis. Data were analyzed using a log-normal survival model, with healing time as the dependent variable. In this model, treatment groups were compared by using estimated healing time ratios. The healing time ratio was adjusted for age (years), ulcer duration (days), length (cm), width (cm), depth (cm), ulcer location (toe, metatarsal head [MTH]), crossover (yes or no, patient with telemedicine and DFP visit) and University of Texas grading for diabetic foot wounds (grade 1: superficial; grade 2: deep; or Grade 3: deep to bone). 22P values from the model were generated by permutation testing, which requires less stringent assumptions to deal with small, unequal sample sizes. 23 Healing times of patients lost to follow-up were censored at 12 weeks for model estimation.
No differences were found between the telemedicine and the DFP groups in the percentage of females (P = .679), age (P = .595), ulcer duration (P = .496), wound width (P = .151), wound length (P = .329), or wound depth (P = .112) (Table 1). No differences were found between the telemedicine and the DFP group in ulcer grade (P = .023) (Table 1) and ulcer location (P = .028) (Table 2).
An independent t test showed no difference in the unadjusted forefoot ulcer healing time between the telemedicine group and DFP group (43 ± 29.3 days vs. 45.5 ± 43.4 days, P = .828) (Table 3). Chi-square analysis found no difference (P = .546) between the percent of ulcers healed in telemedicine group (75%, 15 of 20) and the DFP group (81%, 97 of 120). Three of 20 (15%) telemedicine patients and 7 of 120 (5.8%) DFP patients either did not heal or were lost to follow-up. Stepwise log regression analysis showed age (P = .054), ulcer grade (P < .001), and width (P = .012) were significantly related to the healing time ratio. Results were similar when ulcer grades 2 and 3 were combined in the analysis. Ulcer duration (P = .603), depth (P = .318), length (P = .513), and crossover (P = .866) did not add significantly to the model. In addition, ulcer location was not significantly related to healing time ratio (P = .915), however, it was included in the model because the telemedicine and DFP groups differed significantly on this variable. Table 3 shows that after adding age, ulcer grade (1, 2, or 3), location, and width into the model, no differences were found in the healing time ratio between the DFP group (1.00, reference level) and the telemedicine group (1.40, P = .104, 95% confidence interval = 0.91 < time ratio < 2.01).
The comprehensive foot care provided by the DFP has previously been shown to be effective in reducing the morbidity and loss of limb associated with diabetes. 4–7 Unfortunately, only a limited number of patients with diabetes-related foot problems are able to overcome the distance, transportation, and economic barriers to visit the DFP. Study results suggest that telemedicine may help overcome barriers to accessing care by leveraging and extending the health care delivery infrastructure available in metropolitan centers (for example, patient care, patient education, and clinician education) to patients and caregivers in rural locations. Real-time interactive video consultation enabled a nurse specialist to coordinate and to effectively manage the care of diabetes-related foot ulcers at a small rural medical center.
Although this study showed no difference in the unadjusted forefoot ulcer healing time or the percentage of ulcers healed between the telemedicine and DFP treatment groups, the authors cautiously conclude that forefoot ulcer care was equivalent in the 2 groups. The study was limited by the small sample size of the telemedicine group (risk of a type II error) and the need for some patients in the telemedicine group to be seen on-site at the DFP for specialized off-loading devices, which were not available at LKMC.
In previous studies of neuropathic forefoot ulcer care, which emphasized off-loading, 58% to 90% of ulcers healed in 12 weeks. 4,20,24,25 These results are much more effective than standard foot ulcer care without an emphasis on off-loading (24% of ulcers healed in 12 weeks). 26 In the present pilot study, data appear to show that forefoot ulcer healing in both the telemedicine and DFP groups was comparable to previous studies using off-loading (75% and 81% of ulcers, respectively, healed in 12 weeks). The authors did not analyze which off-loading method was most effective because off-loading method was not randomized and additional methods were used in the DFP group.
Although the store-and-forward photographic images seem reliable 16 and valid 16–17 for the off-site assessment of trunk and lower extremity vascular and pressure ulcers, the validity and reliability of real-time telemedicine for patients with diabetes-related forefoot ulcers has not been studied. In preparation for the present pilot study, the authors evaluated the clinical practicability and face validity of telemedicine assessment for diabetes foot care. Two DFP clinicians examined 12 patients. One clinician conducted the examination directly; the other interacted with the patient only over a telemedicine connection between adjoining rooms at the DFP. Both clinicians evaluated the patients on several predetermined items, including the foot-risk category, skin/wound condition, ulcer/wound grade, callous rating, and adequacy of footwear and off-loading methods. Clinicians agreed on assessment and treatment decisions for the 12 patients, and concluded that telemedicine appeared feasible as a method to reliably participate in evaluation and treatment from a remote location.
The similarity in healing rates may be attributed to increased access to appropriately trained practitioners, rather than the use of telemedicine technology per se. The decision pathway for the staged management of diabetes foot problems may empower the nurse specialist to independently develop treatment plans. Telemedicine, however, also enables timely access to a physician and to multidisciplinary foot care specialists, which greatly speeds the delivery of care and resolution of treatment problems that previously were referred to the DFP. The authors believe that telemedicine consultations enhanced the nurse specialist’s ability to see patients she may not have seen in a remote setting.
This study did not analyze the improvement in effectiveness in ulcer management at LKMC over time. The authors believe the ongoing mentoring by the DFP staff during the real-time telemedicine consultations enhanced the LKMC nurse specialist’s ability to manage foot ulcerations in a timely manner. Early in the study, telemedicine-managed cases were still required to visit the DFP for modification of specialized off-loading devices. Over time, improvement in the nurse specialist’s skill in fabricating offloading devices and the availability of a prefabricated healing shoe (OrthoWedge shoe; Darco, Huntington, WV) reduced the need for patients to travel to the DFP.
Ten patients in the telemedicine group crossed over for a single visit to the DFP for provision of a specialized off-loading device. Crossover did not affect healing time, according to the regression model.The intent of telemedicine is to reduce, in a clinically equivalent way, the number of visits to a specialized foot clinic, but not necessarily to eliminate all visits. Therefore, the authors believe that limited crossover is not a confounding factor in evaluating the feasibility of telemedicine in foot evaluations and treatment.
Current real-time video equipment for telemedicine is inexpensive relative to the salaries of specialized staff. The authors found that telemedicine equipment was easy to use and provided clear viewing of foot lesions and X-rays. Patients appeared well satisfied with use of the technology, appreciated the convenience of being treated at their local facility, had more timely access to specialized care, and saved the time and cost of travel over the course of therapy. The network capabilities required to transmit real-time video images may not be available to all programs and do require additional ongoing costs.
In spite of the limitations of a small sample size and risk of type II error, the authors believe these preliminary data demonstrate that telemedicine is a feasible method for expanding the delivery of specialized diabetes foot care to rural populations. These findings suggest that additional work in this area, including randomized controlled studies of telemedicine for the treatment of foot ulcerations, is warranted. Telemedicine offers the opportunity to increase patients’quality of life by promoting timely diagnosis and treatment of acute problems for patients with diabetes who would otherwise be unable to access the care.
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