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Fifteen percent of individuals with diabetes will likely develop foot ulcers in their lifetime, and approximately 15% to 20% of these ulcers are estimated to result in lower extremity amputation. Techniques to prevent lower extremity amputation range from the simple but often neglected foot inspection to complicated vascular and reconstructive foot surgery. Appropriate management can prevent and heal diabetic foot ulcers, thereby greatly decreasing the amputation rate and medical care costs. Prevention is the key to treatment. The author discusses general guidelines for foot screening and identifies three specific goals for prevention of amputation: 1) identification of at risk individuals needing prevention and the specific factors placing them at risk; 2) protection of the foot against the adverse effects of external forces (pressure, friction, and shear); and 3) reduction of the incidence of diabetic foot ulcers through educational programs.
Vaporous Hyperoxia Therapy (VHTTM), a patented FDA-510 (k) cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). VHT is said to improve the health of wounded tissue by administering a low-frequency, non-contact, non-thermal ionic anti-microbial hydrating mist alternating with concentrated topical oxygen therapy (TOT). VHT was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFU in the study was 11 months old and the average size was over 3 cm2. Wounds were either Wagner Grade 2 or 3 and most commonly on the plantar surface around the midfoot. Treatment consisted of twice weekly applications of VHT and wound debridement. Subjects were followed to wound closure, 20 weeks, or 40 treatments, whichever came first. The combination of SWC and VHT in the group that met and maintained compliance throughout the study period achieved an 83% DFU closure rate within a 20-week time period. The average time for DFU closure in this study was 9.4 weeks. Historical analysis of SWC shows a 30.9% healing rate of all wounds, not differentiating chronic wounds. Accordingly, SWC/VHT increases chronic diabetic foot ulcer healing rates by 2.85 times compared with SWC alone. The purpose of this study was two-fold: first, to observe the effect of VHT on healing rates and time to healing in previously nonhealing DFUs and second, to compare VHT with SWC, TOT and hyperbaric oxygen therapy (HBOT) and ultrasound therapies.
INTRODUCTION AND OBJECTIVES: The benefits of using amniotic tissue in skin regeneration are well documented. Today, cryopreservation technology allows for better availability and maintenance of mesenchymal stem cells. This is of particular interest in treating the diabetic foot ulcer as this population has fewer mesenchymal stem cells. The objective of this case series investigation was to compare the efficacy of cryopreserved human amniotic stem cells in treating foot wounds of different etiologies. We will present data and case photos for a diabetic foot ulcer, venous leg ulcer, arterial ankle ulcer, and a pyoderma gangrenosum ulcer
METHODS: Cryopreserved human amniotic stem cell grafts were applied to patients with chronic ulcers of different etiologies that had been subjected to at least 4 weeks of standard wound care and did not show adequate clinical progress. Wound area was recorded and photographed on weekly basis. Area reduction was charted over time and the results of each individual case were compared to one another.
RESULTS: All ulcers displayed results that well exceeded the established parameters of weekly healing rates for effective wound treatment modalities.
• Pyoderma gangrenosum displayed the poorest response to treatment. However, it is worth noting that the patient was not compliant in the prescribed adjunctive treatment regimen but managed to achieve 64% wound reduction.
• All ulcers showed the largest appreciable amount of healing in both total area reduction and week-to- week closure percentage after the first application.
CONCLUSIONS: Cryopreserved human amniotic stem cell grafts can aid in the decreasing the time to closure of various types of lower extremity ulcerations. The therapy is a clinically viable option for physicians to consider when formulating a treatment plan for a patient with an ulcer.
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.
Wound Care
The Role of Advanced Wound-healing Technologies
Wound repair and regeneration is a highly complex combination of matrix destruction and reorganization. Although major hurdles remain, advances during the past generation have improved the clinician’s armamentarium in the medical and surgical management of this problem. The purpose of this article is to review the current literature regarding the pragmatic use of three of the most commonly used advanced therapies: bioengineered tissue, negative-pressure wound therapy, and hyperbaric oxygen therapy, with a focus on the near-term future of wound healing, including stem cell therapy. (J Am Podiatr Med Assoc 100(5): 385–394, 2010)
Toward a Change in Syntax in Diabetic Foot Care
Prevention Equals Remission
Because neuroischemic complications are associated with a high rate of recurrence, we propose a slight shift in the mechanism by which we counsel and communicate risk daily with our patients. If the epidemiology of this problem is comparable with that of cancer, and recurrences are common, then perhaps language commensurate with such risks should follow. After initial healing of an index wound, our unit now refers to patients not as being cured but rather as being “in remission.” This concept is easy for the patient and the rest of the team to understand. We believe that it powerfully connotes the necessity for frequent follow-up and rapid intervention for inevitable minor and sometimes major complications. (J Am Podiatr Med Assoc 103(2): 161–162, 2013)
