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Over the past three decades, there has been a growing interest in the use of oxygen therapy to promote wound healing. Although the most commonly recognized oxygen therapy for the treatment of chronic wounds is hyperbaric oxygen therapy, topical oxygen therapy has a greater level of evidence supporting its use in chronic wound care. Still, it is imperative that these two treatment modalities be recognized not merely as competitors, but as distinct therapeutic entities. Through personal experience and a thorough literature review, we investigated the use of topical oxygen therapy in the management of chronic wounds. The benefits of using topical oxygen therapy have been demonstrated in patients with diabetic foot ulcers, ischemic ulcers, post-revascularization ulcers, and pressure ulcers. There are several topical oxygen devices currently on the market that are versatile, relatively low-risk, and generally well-tolerated by patients. While these devices have been used in the treatment of chronic wounds at different locations and of different etiologies, other uses of these devices are still being investigated. Topical oxygen therapy is yet another tool in our arsenal to be used in treating difficult to heal chronic wounds and could potentially be used more readily.

An open label, multicenter 16-week trial of cryopreserved human umbilical cord (TTAX01) was previously undertaken in 32 subjects presenting with a Wagner grade 3 or 4 diabetic foot ulcer, with 16 (50%) of these having confirmed closure following a median of one product application (previous study). All but two subjects (30/32; 94%) consented to participate in this follow-up study to 1-year postexposure. No restrictions were placed on treatments for open wounds. At 8-week intervals, subjects were evaluated for adverse events (AEs) and wound status (open or closed). Average time from initial exposure to end of follow-up was 378 days (range 343-433), with 29 of 30 (97%) subjects completing a full year. AEs were all typical for the population under study, and none were attributed to prior exposure to TTAX01. One previously healed wound re-opened, one previously unconfirmed closed wound remained healed, and nine new wound closures occurred, giving 25 of 29 (86.2%) healed in the ITT population. Three of the new closures followed the use of various tissue-based products. Three subjects whose wounds were healed required subsequent minor amputations due to osteomyelitis, one of which progressed to a major amputation (1/29; 3.4%). One additional subject underwent two minor amputations prior to healing. Overall, the study found TTAX01 to be safe in long-term follow-up and associated with both a low rate of major amputation and a higher than expected rates of healing., (© 2020 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)

Clinical trials of potential new therapies for diabetic foot ulcers rarely enroll patients whose wounds extend to muscle, fascia, or bone with clinical and radiographic evidence of underlying osteomyelitis. An open-label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2-47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0-9.6) cm 2 . Aggressive surgical debridement at baseline resulted in 17 minor amputations and an increase in mean wound area to 7.4 ± 5.8 (range: 1.1-28.6) cm 2 . All subjects were placed on systemic antibiotics for at least 6 weeks in conjunction with baseline application of TTAX01. Repeat applications were made at no less than 4-week intervals over the 16-week trial. Initial closure occurred in 18 of 32 (56%) wounds, with 16 (50%) of these having confirmed closure in 16 weeks with a median of one-product application. Cases with biopsy confirmed osteomyelitis (n = 20) showed initial closure in 12 (60%) wounds and confirmed closure in 10 (50%) wounds. Four of the five ulcers presenting as recurrences experienced confirmed closure. Mean overall time to healing was 12.8 ± 4.3 weeks. Mean wound area reduction from baseline was 91% for all wounds. Of the 16 wounds without confirmed closure during the 16-week treatment period, five (31.3%) achieved 99-100% wound area reduction by their final visit. The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis; however, there were no major amputations., (© 2019 The Authors. Wound Repair and Regeneration published by Wiley Periodicals, Inc. on behalf of by the Wound Healing Society.)

Diabetes Mellitus is a serious systemic illness that has an epidemic-like increasing prevalence in the United States, as well as the rest of the world. With the increasing number of people with diabetes comes the higher incidence of diabetes-related complications. One of these known complications, diabetic foot ulcers (DFU), has an estimated lifetime incidence of 15% in diabetics. Having a DFU increases the risk of infection, amputation, and even death, which is why prompt treatment and surveillance of such ulcers is imperative. Multiple organizations and journals have recently published best practices to heal and close DFU. Despite these guidelines, it is estimated that only 50% of all diabetic foot ulcers close within one year in the United States. To further confuse this picture, many trials include postoperative wounds that behave in a very different way than chronic wounds. The management of diabetic ulcers requires an understanding of not only the pathophysiology along with a multi-modal approach involving local wound care, pressure prevention, infection control, and, in some, revascularization, but also how care is delivered in the United States presently. In this review, we hope to elucidate the current knowledge and modalities used in ulcer management and to focus on key areas and best practices to inform the clinician, both in what they should do and what they can do.

Few studies regarding wound treatment with topical antimicrobials evaluate change in the bacterial bioburden of the wound with treatment. This study sought out to determine the in vivo effect of cadexomer iodine antibacterial dressing on diabetic foot ulcers (DFUs) that were infected or achieved a critical level of colonisation, looking specifically at wound progression in relation to bioburden. Fifteen patients corresponding to 16 total DFUs met criteria of displaying clinical signs of infection or critical colonisation and were suitable for a topical antibacterial dressing. They underwent weekly treatment for 6 weeks. Cultures were taken at week 0, 3 and 6 as appropriate. At week 6 median log10 bacterial count reduction of 1.0 was observed from baseline (p = 0·025). At week 3- a median log10 bacterial count reduction of 0.3 was observed from baseline (p = 0·049). Over the study period there was a 53.6% median reduction of the wound surface area. There were no patients that completely healed their ulcer over the 6 week study period. There was a statistically significant median reduction in the bacterial load over the 6 week period (p = 0·025) as well as 3 weeks (p = 0·049). This was accompanied by a median reduction of 53.6% in ulcer surface area and 50% in ulcer depth from baseline to final., (© 2012 The Authors. International Wound Journal © 2012 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Objective: There are numerous dressings designed to manage the overabundance of matrix metalloproteinases, while also addressing the excessive bioburden found in chronic wounds. The authors compared the efficacy of 2 such dressings: a sodium carboxymethylcellulose/1.2% ionic silver (CMC), which theoretically reduces bacteria by providing silver ions, versus a bovine native collagen (BDC)/ionic silver dressing, which also delivers silver ions in an aqueous environment. Both dressings theoretically modulate the wound bed; CMC through moist wound care and fibrin ingrowth and BDC through matrix metalloproteinase balancing., Methods: A prospective protocol was undertaken using patients as their own controls. Ten patients with bilateral venous stasis or diabetic foot ulcers were selected. One limb was randomized to treatment by either CMC or BDC, whereas the contralateral wound was treated with the other dressing. Biopsies for quantitative cultures were taken at weeks 1 and 4. Wound area was assessed at the weekly visits., Results: The BDC wounds started with 1.0 × 10 (±1.2 × 10) bacteria, and the CMC wounds started with 1.4 × 10 (±1.3 × 10) bacteria. Over the 4-week period, the bacteria in the 3-ppm (parts per million) silver-treated wound increased 1.53 × 10, whereas in the 21-ppm silver-treated wound, the bacteria increased 1.42 × 10. The rates of closure for CMC-treated wounds was 0.79 ± 0.735 cm/wk and for BDC-treated wounds was 1.38 ± 1.44 cm/wk. Only 1 wound treated with either dressing exhibited a decrease in bacteria., Conclusion: Both CMC and BDC silver dressings appeared to have statistically similar efficacy regarding the rate of wound healing and little impact on the actual bioburden in chronic lower-extremity wounds. Interestingly, there was no correlation in the size of the wound and any effect on bioburden. Although the BDC dressing showed a higher absolute rate of wound closure, neither technology demonstrated a statistically significant difference in wound closure rate when corrected for initial wound size.

In many series of diabetic foot ulcer care, heel ulcers greater than 4 cm across have been identified as an independent predictor of limb loss. Therefore, we set out to pursue the most aggressive limb salvage algorithm in patients with heel ulcers greater than 4 cm in diameter. Over 5 years, we identified 21 patients, 39-84 years of age, all with diabetes mellitus, with heel ulcers greater than 4 cm in diameter and had magnetic resonance imaging or bone scan evidence of osteomyelitis. Seven of the 21 patients had end-stage renal disease defined as being haemodialysis dependent. All patients had ankle brachial indices <0·4 or monophasic pulse volume recordings. All patients underwent distal bypass surgery with vein. After adequate perfusion was obtained, all patients underwent partial calcanectomy and intra-operative negative pressure wound therapy (NPWT) placement. This was followed by treatment with recombinant platelet-derived growth factor (PDGF). One patient underwent amputation during the healing process secondary to ongoing sepsis. Twenty of 21 patients healed acutely (within 6 months). Three of 20 patients went on to subsequent below knee amputation within 12 months of healing primarily. At 2 years, 12 of 21 (57%) were ambulating independently, 1 of 21 was dead, 4 of 21 had undergone amputation, 4 (19%) had limbs that were intact but were not ambulating. A total limb salvage rate of 76% at 2 years mirrored the secondary patency rates, with 100% follow up. Heel ulcers require multimodality therapy if they are going to have any chance to heal. We believe the algorithm presented allows for the required revascularisation and a modulation of the heel ulcer microenvironment by augmenting the microcirculation through NPWT, and improving the proliferative capacity with PDGF., (© 2011 The Authors. © 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Introduction: The 2-year cost of a new diabetic foot ulcer (DFU) is estimated to be $27,987. These costs are thought to be secondary to hospitalization, amputation, and the duration of care. Treatments that accelerate rapid and complete healing of DFUs reduce the need for hospitalization, thus reducing the costs of care. One of the therapies previously shown to lead to more rapid and complete wound healing of DFUs is recombinant human platelet-derived growth factor (rhPDGF). Many centers, however, do not initiate rhPDGF therapy, based on patient cost issues. Therefore, many centers reserve a potentially cost-saving therapy as a second- or third-line therapy. The goal of the authors' analysis was to examine the actual cost to patients of a policy of initiating rhPDGF as the initial therapy for appropriately debrided DFUs., Methods: A 12-month retrospective analysis of all patients presenting to a tertiary care referral wound practice with the diagnosis of DFUs was performed. The algorithm the authors followed specified that all wounds of patients with an ankle brachial index of greater than 0.7 and a diagnosis of DFUs (that were not enrolled in a research protocol) were debrided widely (ie, all wounds were debrided sharply with a 45-degree bevel on the border and the bases of the wounds were sharply debrided to a clean granular base), provided off-loading, and initiated on rhPDGF at the patients' first center visit. The patient payer mix and average cost-per-patient per year were analyzed, and the average number of tubes of rhPDGF was recorded., Results: There were 121 patients with the diagnosis of DFUs, representing 766 visits. A total of 187 tubes of rhPDGF were prescribed for these 121 patients over the course of 12 months. There was an average use of 1.54 tubes per patient. The primary payer mix was Medicare, 44%; Medicaid, 27%; and private-payer mix, 29%, representing 10 companies. The average patient cost per tube was $28, the average cost for Medicare was $25 (many with secondary payers, as data predate 2006 Medicare D), Medicaid was $2, and private insurance was $71. Therefore, the average patient cost per course of therapy was $42., Discussion: The average cost to patients with prescription benefits for a course of rhPDGF therapy, over a diverse and representative patient mix, is less than $50 in an inner-city tertiary care facility. Thus, patient cost alone should not provide a barrier to initiating active therapy in the form of rhPDGF to the patient presenting with a DFU. This early initiation could potentially lead to lower overall health costs by improving wound-healing outcomes.