Background: While numerous studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated. In this pilot study, we examined the potential effectiveness of lower extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers (DFUs). Methods: Thirty-eight patients with DFUs were recruited. Participants underwent 60-minutes of active E-Stim therapy provided on acupuncture points above the level of the ankle joint using a bio-electric stimulation technology® (BEST) platform (Tennant Biomodulator® PRO). As primary outcome, changes in perfusion in response to E-Stim were assessed by measuring skin perfusion pressure (SPP) at baseline, 30-, and 60-min during therapy. In addition, retention was assessed 10-min post-therapy. As secondary outcome, tissue oxygen saturation (SatO2) was measured using a non-invasive near-infrared camera (Snapshot NIR, KENT Imaging Inc). Results: SPP increased in response to E-Stim therapy (p = 0.02) with maximum improvement observed at 60-min (11%, p = 0.007) compared to baseline. SPP reduced at 10-min post therapy, but remained higher than baseline (9%, p = 0.1). Magnitude of improvement at 60-min was negatively correlated with baseline SPP values (r = -0.45, p = 0.01) suggesting those with lower perfusion could benefit more from E-Stim therapy. Similar trends were observed for SatO2 with statistically significant improvement for a sub-sample (n=16) with moderate-severe peripheral arterial disease (Ankle brachial index < 0.8 or > 1.4). Conclusions: This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and SatO2. The magnitude of benefit is higher among those with poorer skin perfusion. Results also suggest the effects of E-Stim could be washed out after stopping therapy and thus regular daily application may be required for the effective benefit for wound healing.
Although numerous studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated. In this pilot study, we examined the potential effectiveness of lower-extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers.
Thirty-eight patients with diabetic foot ulcers underwent 60 min of active E-Stim therapy on acupuncture points above the level of the ankle joint using a bioelectric stimulation technology platform. Perfusion changes in response to E-Stim were assessed by measuring skin perfusion pressure (SPP) at baseline and during 30 and 60 min of therapy; retention was assessed 10 min after therapy. Tissue oxygen saturation (SatO2) was measured using a noninvasive near-infrared camera.
Skin perfusion pressure increased in response to E-Stim therapy (P = .02), with maximum improvement observed at 60 min (11%; P = .007) compared with baseline; SPP reduced 10 min after therapy but remained higher than baseline (9%; P = .1). Magnitude of improvement at 60 min was negatively correlated with baseline SPP values (r = –0.45; P = .01), suggesting that those with lower perfusion could benefit more from E-Stim therapy. Similar trends were observed for SatO2, with statistically significant improvement for a subsample (n = 16) with moderate-to-severe peripheral artery disease.
This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and SatO2. The magnitude of benefit is higher in those with poorer skin perfusion. Also, the effects of E-Stim could be washed out after stopping therapy, and regular daily application might be required for effective benefit in wound healing.
Diabetic foot ulcers combined with ischemia and infection can be difficult to treat. Few studies have quantified the level of blood supply and infection control required to treat such complex diabetic foot ulcers. We aimed to propose an index for ischemia and infection control in diabetic chronic limb-threatening ischemia (CLTI) with forefoot osteomyelitis.
We retrospectively evaluated 30 patients with diabetic CLTI combined with forefoot osteomyelitis who were treated surgically from January 2009 to December 2016. After 44 surgeries, we compared patient background (age, sex, hemodialysis), infection status (preoperative and 1- and 2-week postoperative C-reactive protein [CRP] levels), surgical bone margin (with or without osteomyelitis), vascular supply (skin perfusion pressure), ulcer size (wound grade 0–3 using the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification), and time to wound healing between patients with healing ulcers and those with nonhealing ulcers.
Preoperative CRP levels and the ratio of ulcers classified as wound grade 3 were significantly lower and skin perfusion pressure was significantly higher in the healing group than in the nonhealing group (P < .05). No other significant differences were found between groups.
This study demonstrates that debridement should be performed first to control infection if the preoperative CRP level is greater than 40 mg/L. Skin perfusion pressure of 55 mm Hg is strongly associated with successful treatment. We believe that this research could improve the likelihood of salvaging limbs in patients with diabetes with CLTI.
The timely and accurate noninvasive assessment of peripheral arterial disease is a critical component of a limb preservation initiative in patients with diabetes mellitus. Noninvasive vascular studies can be useful in screening patients with diabetes for peripheral arterial disease. In patients with clinical signs or symptoms, noninvasive vascular studies provide crucial information on the presence, location, and severity of peripheral arterial disease and an objective assessment of the potential for primary healing of an index wound or a surgical incision. Appropriately selected noninvasive vascular studies are important in the decision-making process to determine whether and what type of intervention might be most appropriate given the clinical circumstances. Hemodynamic monitoring is likewise important after either an endovascular procedure or a surgical bypass. Surveillance studies, usually with a combination of physiologic testing and imaging with duplex ultrasound, accurately identify recurrent disease before the occurrence of thrombosis, allowing targeted reintervention. Noninvasive vascular studies can be broadly grouped into three general categories: physiologic or hemodynamic measurements, anatomical imaging, and measurements of tissue perfusion. These types of tests and suggestions for their appropriate application in patients with diabetes are reviewed. (J Am Podiatr Med Assoc 100(5): 406–411, 2010)
We sought to develop a consensus statement for the use of off-loading in the management of diabetic foot ulcers (DFUs).
A literature search of PubMed for evidence regarding off-loading of DFUs was initially conducted, followed by a meeting of authors on March 15, 2013, in Philadelphia, Pennsylvania, to draft consensus statements and recommendations using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach to assess quality of evidence and develop strength of recommendations for each consensus statement.
Evidence is clear that adequate off-loading increases the likelihood of DFU healing and that increased clinician use of effective off-loading is necessary. Recommendations are included to guide clinicians on the optimal use of off-loading based on an initial comprehensive patient/wound assessment and the necessity to improve patient adherence with off-loading devices.
The likelihood of DFU healing is increased with off-loading adherence, and, current evidence favors the use of nonremovable casts or fixed ankle walking braces as optimum off-loading modalities. There currently exists a gap between what the evidence supports regarding the efficacy of DFU off-loading and what is performed in clinical practice despite expert consensus on the standard of care.
Background: People with diabetic foot ulcers report poor quality of life. However, prospective studies that chart quality of life from the onset of diabetic foot ulcers are lacking. We describe change in quality of life in a cohort of people with diabetes and their first foot ulcer during 18 months and its association with adverse outcomes.
Methods: In this prospective cohort study of adults with their first diabetic foot ulcer, the main outcome was change in Medical Outcomes Study 36-Item Short Form Health Survey scores between baseline and 18-month follow-up. We recorded baseline demographics, diabetes characteristics, depression, and diabetic foot outcomes and mortality at 18 months.
Results: In 253 people with diabetes and their first ulcer, there were 40 deaths (15.8%), 36 amputations (15.5%), 99 recurrences (43.2%), and 52 nonhealing ulcers (21.9%). The 36-Item Short Form Health Survey response rate of survivors at 18 months was 78% (n = 157). There was a 5- to 6-point deterioration in mental component summary scores in people who did not heal (adjusted mean difference, −6.54; 95% confidence interval, −12.64 to −0.44) or had recurrent ulcers (adjusted mean difference, −5.30; 95% confidence interval, −9.87 to −0.73) and a nonsignificant reduction in those amputated (adjusted mean difference, −5.00; 95% confidence interval, −11.15 to 1.14).
Conclusions: Quality of life deteriorates in people with diabetes whose first foot ulcer recurs or does not heal within 18 months. (J Am Podiatr Med Assoc 99(5): 406–414, 2009)
We aimed to evaluate surrogate markers commonly used in the literature for diabetic foot osteomyelitis remission after initial treatment for diabetic foot infections (DFIs).
Thirty-five patients with DFIs were prospectively enrolled and followed for 12 months. Osteomyelitis was determined from bone culture and histologic analysis initially and for recurrence. Fisher exact and χ2 tests were used for dichotomous variables and Student t and Mann-Whitney U tests for continuous variables (α = .05).
Twenty-four patients were diagnosed as having osteomyelitis and 11 as having soft-tissue infections. Four patients (16.7%) with osteomyelitis had reinfection based on bone biopsy. The success of osteomyelitis treatment varied based on the surrogate marker used to define remission: osteomyelitis infection (16.7%), failed wound healing (8.3%), reulceration (20.8%), readmission (16.7%), amputation (12.5%). There was no difference in outcomes among patients who were initially diagnosed as having osteomyelitis versus soft-tissue infections. There were no differences in osteomyelitis reinfection (16.7% versus 45.5%; P = .07), wounds that failed to heal (8.3% versus 9.1%; P = .94), reulceration (20.8% versus 27.3%; P = .67), readmission for DFIs at the same site (16.7% versus 36.4%; P = .20), amputation at the same site after discharge (12.5% versus 36.4%; P = .10). Osteomyelitis at the index site based on bone biopsy indicated that failed therapy was 16.7%. Indirect markers demonstrated a failure rate of 8.3% to 20.8%.
Most osteomyelitis markers were similar to markers in soft-tissue infection. Commonly reported surrogate markers were not shown to be specific to identify patients who failed osteomyelitis treatment compared with patients with soft-tissue infections. Given this, these surrogate markers are not reliable for use in practice to identify osteomyelitis treatment failure.
This review discusses some of the significant studies and events from the 61st American Diabetes Association’s Scientific Symposium. Many of the issues raised at the meeting will form building blocks for future research into offloading, footwear, wound classification, wound healing, tissue engineering, and psychological aspects of therapy and prevention. (J Am Podiatr Med Assoc 92(1): 2-6, 2002)
Diabetic foot ulcers (DFUs) are a major burden to patients and to the health-care systems of many countries. To prevent or treat ulcers more effectively, predictive biomarkers are needed. We examined temperature as a biomarker and as a causative factor in ulcer development.
Thirty-seven individuals with diabetes were enrolled in this observational case-control study: nine with diabetic neuropathy and ulcer history (DFU), 14 with diabetic neuropathy (DN), and 14 nonneuropathic control participants (DC). Resting barefoot plantar temperatures were recorded using an infrared thermal camera. Mean temperatures were determined in four anatomical regions—hallux and medial, central, and lateral forefoot—and separate linear models with specified contrasts among the DFU, DN, and DC groups were set to reveal mean differences for each foot region while controlling for group characteristics.
The mean temperature reading in each foot region was higher than 30.0°C in the DFU and DN groups and lower than 30.0°C in the DC group. Mean differences were greatest between the DFU and DC groups, ranging from 3.2°C in the medial forefoot to 4.9°C in the hallux.
Increased plantar temperatures in individuals with a history of ulcers may include acute temperature increases from plantar stresses, chronic inflammation from prolonged stresses, and impairment in temperature regulation from autonomic neuropathy. Diabetic foot temperatures, particularly in patients with previous ulcers, may easily reach hazard thresholds indicated by previous pressure ulcer studies. The results necessitate further exploration of temperature in the diabetic foot and how it may contribute to ulceration.