The efficacy of concentrated autologous platelet-derived growth factors in the healing and closure of chronic lower-extremity wounds was evaluated in 24 patients with 33 lower-extremity wounds treated previously for at least 6 months using traditional methods. Surgical wound debridement was performed to convert chronic ulcers into acute wounds. Concentrated autologous platelet-derived growth factors and thrombin were applied to the wound bases and protected with a nonadhering compression dressing that remained intact for 7 days. Wounds were evaluated and the concentrate was reapplied every 2 weeks. Wound closure and complete epithelialization was achieved in 20 wounds. Seventy-five percent or greater wound closure was obtained in three wounds, 50% to 74% closure in three wounds, and 25% to 49% closure in two wounds. Five wounds displayed no improvement. Mean time to complete closure was 11.15 weeks. The application of concentrated autologous platelet-derived growth factors and thrombin resulted in substantial wound healing and wound-diameter reduction. This technique constitutes a safe and effective treatment option and avoids lengthy treatment periods that increase the potential for infection. (J Am Podiatr Med Assoc 96(6): 482–488, 2006)
Background: Vaporous hyperoxia therapy (VHT), a patented US Food and Drug Administration 510 (k)–cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). Vaporous hyperoxia therapy is said to improve the health of wounded tissue by administering a low-frequency, noncontact, nonthermal, ionic, antimicrobial hydrating mist alternating with concentrated topical oxygen therapy.
Methods: Vaporous hyperoxia therapy was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFUs in the study was 11 months and the average size was over 3 cm2. Wounds were 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.
Results: 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 period. The average time for DFU closure in this study was 9.4 weeks.
Conclusions: 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, topical oxygen therapy, hyperbaric oxygen therapy, and ultrasound therapy.
The Amputation Prevention Initiative is a project conducted jointly by the Massachusetts Public Health Association and the Massachusetts Podiatric Medical Society that seeks to study methods to reduce nontraumatic lower-extremity amputations from diabetes.
To determine the rate of diabetes-related lower-extremity amputations in Massachusetts and identify the groups most at risk, hospital billing and discharge data were analyzed. To examine the components of the diabetic foot examination routinely performed by general practitioners, surveys were conducted in conjunction with physician meetings in Massachusetts (n = 149) and in six other states (n = 490).
The average age-adjusted number of diabetes-related lower-extremity amputations in 2004 was 30.8 per 100,000 and 5.3 per 1,000 diabetic patients in MA, with high-risk groups being identified as men and black individuals. Among the general practitioners surveyed in Massachusetts, only 2.01% reported routinely conducting all four key components of the diabetic foot examination, with 28.86% reporting not performing any components.
These findings suggest that many general practitioners may be failing to perform the major components of the diabetic foot examination believed to prevent foot ulcers and lower-extremity amputations.
Throughout our medical training, we are taught how to manage patients who present with symptoms: perform a clinical examination, make a diagnosis, and develop a management plan. However, virtually no time is spent on teaching us how to manage patients who have no symptoms because they have lost the ability to feel pain, that is, patients with peripheral neuropathy. The lifetime incidence of foot ulceration in people with diabetes has been estimated to be as high as 25%, and a variety of contributory factors result in a foot being at risk for ulceration. Most important among these factors is peripheral neuropathy, or the loss of the ability to feel pain, temperature, or pressure sensation in the feet and lower legs. Up to 50% of older type 2 diabetic patients have evidence of sensory loss, putting them at risk for foot ulceration. If we are to succeed in reducing the high incidence of foot ulcers, regular screening for peripheral neuropathy is vital in all patients with diabetes. Those found to have any risk factors for foot ulceration require special education and more frequent review, particularly by podiatric physicians. The key message is, therefore, that neuropathic symptoms correlate poorly with sensory loss and that their absence must never be equated with lack of risk of foot ulceration. If we are to succeed in reducing the high incidence of foot ulceration and particularly recurrent ulceration, we must realize that with loss of pain there is also diminished motivation in the healing and prevention of injury. (J Am Podiatr Med Assoc 100(5): 349–352, 2010)
A middle-aged man presented for left foot diabetic ulcer care. Pedal radiographs were negative for signs of osteomyelitis. However, asymptomatic incidental osseous findings demonstrated significant plantar and posterior calcaneal spurring possibly consistent with diffuse idiopathic skeletal hyperostosis (DISH). A differential of DISH, psoriatic arthritis, Reiter’s, and ankylosing spondylitis was developed. Subsequent spinal imaging and laboratory work-up did not satisfy the diagnostic criteria for DISH. This case illustrates radiographic changes characteristic of multiple seronegative arthropathies. On initial presentation a diagnosis of DISH was most likely, but with further imaging studies a diagnosis of a variant of psoriatic arthritis may be more correct. (J Am Podiatr Med Assoc 102 (5): 422-427, 2012)
Background: Off-loading excessive pressure is essential to healing diabetic foot ulcers. However, many patients are not compliant in using prescribed footwear or off-loading devices. We sought to validate a method of objectively measuring off-loading compliance via activity monitors.
Methods: For 4 days, a single subject maintained a written compliance diary concerning use of a removable cast walker. He also wore a hip-mounted activity monitor during all waking hours. An additional activity monitor remained mounted on the cast walker at all times. At the conclusion of the 4 days, the time-stamped hip activity data were independently coded for walker compliance by the compliance diary and by using the time-stamped walker activity data.
Results: An intraclass reliability of 0.93 was found between diary-coded and walker monitor–coded activity.
Conclusions: These results support the use of this dual activity monitor approach for assessing off-loading compliance. An advantage of this approach versus a patient-maintained diary is that the monitors are not susceptible to incorrect patient recall or a patient’s desire to please a caregiver by reporting inflated compliance. Furthermore, these results seem to lend support to existing reports in the literature using similar methods. (J Am Podiatr Med Assoc 99(2): 100–103, 2009)
Despite falls being a major concern for people living with somatosensory deficit, little is known about the perceived impact of footwear and footwear features on balance. Clinical relevance is increased given that therapeutic footwear is often provided to people with diabetes to reduce foot ulcer risk. This qualitative study aims to explore the experiences and views of people with diabetes and neuropathy who have recently fallen to understand whether footwear type is perceived to affect balance or contribute to falling.
Sixteen individuals (13 men and three women aged 44–83 years) were purposively sampled from a larger population of potential participants. Audio-recorded, in-depth, semistructured interviews were conducted in participant homes or at a place preferable to them. Once transcribed verbatim, the data were themed, charted, and interpreted using a framework approach.
Although most participants did not believe that the footwear in which they fell contributed to their fall, most revealed how footwear choice influenced their balance confidence to undertake daily tasks. Most found their therapeutic footwear “difficult” to walk in, “heavy, or “slippery bottomed.” Design recommendations for enhanced balance included a close fit with tight fastening, lightweight, substantial tread, and a firm, molded sole/insole. Complying with these recommendations, the hiking sandal was believed to be the most stable and safe shoe and was frequently worn as a walking aid to reduce fear of falling and boost confidence.
People with diabetic neuropathy have disease-specific needs and concerns relating to how footwear affects balance. Engaging with patients to address those needs and concerns is likely to improve the feasibility and acceptability of therapeutic footwear to reduce foot ulcer risk and boost balance confidence. (J Am Podiatr Med Assoc 103(6): 508–515, 2013)
Patients with chronic diabetes have a broad spectrum of associated peripheral neurologic deficits that culminate in an increased susceptibility to ulcer formation. The authors focus on the use of the ankle-foot orthosis as both a treatment and a definitive solution for achieving ulcer closure and for minimizing the chance of ulcer recurrence in the ambulatory patient. An analysis of the pathologic forces encountered, and the solution achieved with the ankle-foot orthosis is presented. In addition, the results from a clinical pilot study in subjects with recalcitrant ulcers secondary to Charcot's neuroarthropathy are presented.
Digestion of collagen with clostridial collagenase (CC) produces peptides that can induce cellular responses consistent with wound healing in vivo. However, nonhealing human wounds are typically in a state of chronic inflammation. We evaluated the effects of CC on markers of inflammation in cell culture and wound fluid from diabetic patients.
Lipopolysaccharide-induced release of tumor necrosis factor-α and interleukin-6 from interferon-γ–activated THP-1 monocytes was measured in the presence or absence of CC or CC collagen digests. In the clinical study, 17 individuals with mildly inflamed diabetic foot ulcers were randomized to receive CC ointment (CCO) or hydrogel. Weekly assessments included wound appearance and measurements. Wound exudate was collected at baseline and at 2 and 4 weeks of treatment. A multiplex assay was used to measure levels of analytes, including those associated with inflammation and with inflammation resolution.
Lower levels of tumor necrosis factor-α and interleukin-6 were found in media of cells cultured with CC or CC digests of collagen type I or III than for untreated lipopolysaccharide controls (P < .05). Clinically, CCO and hydrogel resulted in improvement in wound appearance and a decrease in mean wound area. The CCO, but not the hydrogel, was found to increase the level of analytes associated with resolution of inflammation while decreasing those associated with inflammation. There was a general correlation between resolution of inflammation and healing.
These results support a hypothesis that debridement with CCO is associated with decreased inflammation and greater progress toward healing.
We evaluated whether direct or indirect endovascular revascularization based on the angiosome model affects outcomes in type 2 diabetes and critical limb ischemia.
From 2010 to 2015, 603 patients with type 2 diabetes were admitted for critical limb ischemia and submitted to endovascular revascularization. Among these patients, 314 (52%) underwent direct and 123 (20%) indirect revascularization, depending on whether the flow to the artery directly feeding the site of ulceration, according to the angiosome model, was successfully acquired; 166 patients (28%) were judged unable to be revascularized. Outcomes were healing, major amputation, and mortality rates.
An overall healing rate of 62.5% was observed: patients who did not receive percutaneous transluminal angioplasty presented a healing rate of 58.4% (P < .02 versus revascularized patients). A higher healing rate was observed in the direct versus the indirect group (82.4% versus 50.4%; P < .001). The major amputation rate was significantly higher in the indirect versus the direct group (9.2% versus 3.2%; P < .05). The overall mortality rate was 21.6%, and it was higher in the indirect versus the direct group (24% versus 14%; P < .05).
These data show that direct revascularization of arteries supplying the diabetic foot ulcer site by means of the angiosome model is associated with a higher healing rate and lower risk of amputation and death compared with the indirect procedure. These results support use of the angiosome model in type 2 diabetes with critical limb ischemia.