New antioxidant therapy for hard-to-heal neuroischaemic diabetic foot ulcers with deep exposure
Abstract
Objective:
To evaluate the clinical efficacy of a new antioxidant therapy for the treatment of complex neuroischaemic diabetic foot ulcers (DFUs).
Method:
A prospective case series study has been conducted in patients with complex neuroischaemic DFUs after transmetatarsal amputation. DFUs were locally treated with an antioxidant dressing twice a week for the first two weeks, and then once a week until the end of the study or complete wound closure. Patients were followed-up for eight weeks and assessed weekly to analyse wound outcome. Primary outcomes were the wound closure ratio and percentage of granulation tissue; secondary outcomes were parameters related to wound management, namely, presence of non-viable tissue in the wound bed, levels of maceration and exudates, presence of erythema and pain.
Results:
A total of 20 patients were included with a mean baseline wound area of 20.4cm2. At 8 weeks, the mean reduction in wound area was 88.1% (p<0.0001) and complete closure was observed in 33% of cases. In addition, there was a mean increase of 94.7% in granulation tissue in the wound bed (p<0.0001). Furthermore, the therapy was associated with a significant percentage reduction in wounds with non-viable tissue, good exudate management, and the maintenance of low levels of maceration, erythema and pain.
Conclusion:
The new antioxidant therapy was associated with good clinical outcomes in large hard-to-heal neuroischaemic DFUs, with significant wound area reduction and granulation tissue formation. The therapy was also found to be safe and perform well from a practical perspective.
Declaration of interest:
BC holds the patent that protects the technology under the antioxidant dressing and work in the research and development department of Histocell, the company that has developed the dressing.
The prevalence of diabetes worldwide increases every year, mainly due to an increase in the average age of the population and unhealthy lifestyles (sedentary habits, malnutrition and obesity). Among the various complications associated with diabetes, it is known that 19—34% of patients will develop a diabetic foot ulcer (DFU) in their lifetime,1,2 with a high probability of recurrence, and 15—20% of these ulcers will result in an amputation.3 Following amputation, the clinical management of these wounds is very complicated due to the long and complex healing process that impairs patient quality of life.
There is increasing evidence that the conditions of hyperglycaemia and oxidative stress act concomitantly, jointly contributing to the development of complications of diabetes such as neuropathy and angiopathy, that are directly related to the development of DFUs.4,5 The concept of oxidative stress was first proposed by Sies6, as an imbalance between pro-oxidant and antioxidant molecules in the body in favour of oxidants (mostly reactive oxygen species (ROS)), which leads to an alteration in redox signalling, causing damage at a cellular and molecular level.6,7 The main source of ROS in the body is cellular metabolism through mitochondrial activity.8 Under normoglycaemic conditions, between 0.2—2% of electrons entering the electron transport chain are released from the normal transfer order and interact with oxygen, giving rise to the superoxide anion (O2-) and hydrogen peroxide (H2O2).9 In this situation, the antioxidant defences are able to avoid uncontrolled increases in ROS; they can maintain an oxidative balance, creating conditions of physiological oxidative stress, necessary for wound disinfection and healing. Further, it should be recalled that the redox system contributes to maintaining physiological inflammation, promoting angiogenesis, the formation of new granulation tissue, and the synthesis and deposition of extracellular matrix (ECM), and thereby the achievement of wound closure.10
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