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56 D. Dixon and M. Edmonds
Near Infrared (NIR) Optical Imaging
The use of near infrared (NIR) optical imaging to map haemodynamic changes in
diabetic foot ulcers has been an area of interest. The technology is non-invasive and
non-ionizing and requires no contact. It utilises near infrared light between 650 and
1000 nm which is minimally absorbed and allows deep tissue imaging (Kaile and
Godavarty 2019). NIR has been used as an adjunct to improving surgical
debridement techniques by quantifying the level of tissue oxygenation around areas
of callus after debridement. This was reported from a small multi-centre trial
between Florida and India, to show a greater than 80% change in tissue oxygenation
following debridement (Kaile et al. 2021). Development of smart phone technology
using NIR to aid with non-contact 2D and 3D wound image analysis is still in the
early stages, but is currently being used in a different modality (contact) to aid with
skin cancer assessment and brain imaging (Kaile and Godavarty 2019).
Innovative Technology in Wound Applications to Accelerate
Healing
Historically, there has been a scarcity of evidence-based topical therapy to accelerate the healing of diabetic foot ulcers In 2019, the IWGDF made several recommendations (Rayman et al. 2020). It advised that practitioners consider the use
of the sucrose-octasulfate impregnated dressing in non-infected, neuro-ischaemic
diabetic foot ulcers that are difficult to heal despite best standard of care, following
on from the Explorer study which reported the benefit of sucrose octasulphate
dressing when applied to ulcers in neuroischaemic feet (Edmonds et al. 2018). The
use of LeucoPatch was also recommended as he LeucoPatch study had reported the
benefit of a multi-layered patch comprising autologous leucocytes, platelets, and
fibrin, which releases cytokines and growth factors involved in tissue repair, in a
multinational, observer blinded, randomised, controlled trial (Game et al. 2018).
The IWGDF also recommended the use of placental derived products as an
adjunctive treatment in addition to best standard of care, when the latter alone has
failed to reduce the size of the wound (Tettelbach et al. 2019). Recommendations
were also made by the IWGDF to consider the use of systemic hyperbaric oxygen
therapy as an adjunctive treatment in non-healing ischaemic diabetic foot ulcers
despite best standard of care, and the use of negative pressure wound therapy
(NWPT) to reduce wound size, in addition to best standard of care, in patients with
diabetes and a post-operative (surgical) wound on the foot. In one well-designed
RCT, Armstrong and Lavery (2005) compared NPWT to standard moist wound
care in 162 people with diabetes who had partial foot amputations up to the
transmetatarsal level. They found a healing rate at 16 weeks of 56% compared to
39% in the standard care group. A systematic review and meta-analysis performed
by Liu et al. (
from 11 RCTs involving 1,044 patients concluded that NPWT was 1.48 times more
likely than conventional dressings to heal wounds, with a decreased time to closure
(by 8 days) and a reduced risk of amputation (relative risk 0.31). Three RCTs have
2017)
also compared NPWT to conventional dressings. This analysis
The Diabetic Foot, Its Complications, Role of Technology … 57
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compared conventional NPWT to NPWT with saline instillation. Lavery et al.
showed no difference in a study of 150 patients (Lavery et al. 2020). However, Giri
et al. reported a decreased bacterial burden and decreased wound size in 48 patients
(Giri et al. 2021). Kim et al. found no differences in their primary endpoints but did
demonstrate a 3.1-fold decrease in readmission of patients treated with saline
instillation and NPWT compared to NPWT alone (Kim et al.
2020; Boulton et al.
2022). Although previous studies have been criticized as providing low-certainty
evidence from trials with risk of bias and imprecision, NWPT has become standard
treatment of complex diabetic foot ulcers (Boulton et al. 2022). Overall, there is
evidence that this form of therapy increases granulation tissue, and prospective
RCTs have shown that it accelerates wound healing.
Recently there has been new evidence to support the technology for topical
oxygen therapy (TOT). There are three general types of delivery systems for TOT,
each of which allows for ambulatory or home-based treatment: (1) those generating
continuous delivery of oxygen (CDO) at negligible pressures, (2) low constant
pressure delivery in a contained chamber, and (3) higher cyclically pressurized and
humidified delivery in a contained extremity chamber (Boulton et al. 2022). Using
the cyclically pressurized topical wound oxygen device for healing recalcitrant
diabetic foot ulcers, a robust multicentre, sham-controlled, double-blinded RCT
was reported in 2020 (Frykberg et al. 2020). At the first planned (a priori) interim
analysis point, the active therapy was found to be superior to the sham, with a
closure rate at 12 weeks of 41.7% compared to 13.5% (P = 0.007). Improved
healing rates in the TOT group were also demonstrated by adjusted Cox proportional hazards modelling that yielded a hazard ratio of 4.66 (97.8% CI 1.36–15.98,
P = 0.004). The real-world impact of this device on hospitalizations and amputations in 202 patients with diabetic foot ulcers was reported in
a retrospective,
comparative cohort study (Yellin et al. 2021). It found that 6.6 and 12.1% of those
using cyclically pressurized topical oxygen had hospitalizations and amputations,
respectively, at 1 year, compared to 54.1 and 41.4%, respectively, of those who had
not used this adjunctive topical oxygen modality (each P < 0.0001).
Innovative Technology in Cellular and Molecular Therapies
to Accelerate Healing
Stem Cell Therapy
The use of stem cell therapy to enhance the physiological processes of wound
healing in diabetic foot ulcers has led to the development of various dressings and
topical applications These techniques facilitate the delivery of growth factors,
cytokines and chemokines within a structure or medium which maximises exposure
of the wound to the relevant components to aid wound healing.
Using stem cell therapy to develop mesenchymal and mononuclear cell lineages
has been shown to produce higher levels of collagen and growth factors, leadi ng to
faster wound healing compared to standard care alone (Albehairy et al. 2018).
There were significantly higher rates of ulcer surface area reduction in those treated
58 D. Dixon and M. Edmonds
with mesenchymal or mononuclear groups of stem cells [68% with mesenchymal,
59% with mononuclear] compared to the controls [6.25%, p < 0.05] at 12 weeks
(Albehairy et al. 2018). There was no significant difference in ulcer healing between
the two stem cell treated groups. Adipose stem cells, known to be an abundant
source of mesenchymal stem cells, showed 80% healing at 6 months post
lower-limb min or amputation, compared with 46% in the control group of standard
care alone (p = 0.0064) (Lonardi et al.
2019).Ameta-anal
ysis of the efficacy of
stem cell therapy in the treatment of diabetic foot ulcers looked at 14 studies with
683 participants. It concluded that stem cell therapy was more effective than
standard treatment regarding ulcer healing, improving lower extremity ischaemia,
increasing pain free walking distance and reducing rest-pain score compared with
conventional therapy. It also demonstrated a reduction in amputation rates (Sun
et al. 2022). However, there is a need for larger studies, involving multi-centre
involvement with randomized double-blind placebo controlled trials to further
evaluate long term efficacy of this treatment.
Gene Therapy
Developments in gene therapy using viral vectors to deliver growth factors to sites
of ulcers is still in the early phases. Initial trials show some promise with the use of
non-viral vectors in terms of lower risk of stimulating adverse side effects such as
exaggerated immune responses, carcinogenesis and insertional mutagenesis.
However, the use of viral vectors has demonstrated better therapeutic effects with
lower levels of adverse effects (Kwon et al. 2012; Dixon and Edmonds 2021).
Nanotechnology
There are a number of trials in the early stages of investigation looking at different
medium
o deliver targeted gene therapy to affected sites including those using
s t
nanotechnology. Exploration of the use of lipid nano-carriers (liposomes, solid lipid
nanoparticles, niosomes and ethosomes) as drug delivery systems has shown promise in aiding diabetic foot ulcer healing (Kandregula et al. 2022). The lipid
nano-carriers can be used to encapsulate nucleic acids like siRNA and miRNA to
silence the expression of inflammatory cytokines which are often seen in chronic
wounds. They can also be used to encapsulate proteins, peptides and growth factors
which can be d elivered to the wound bed and facilitate wound healing (Kandregula
et al. 2022)
Devel
efits
.
opments in nanotechnology to aid wound healing have shown early ben-
in animal models of rats with diabetic neuropathy and ulceration. The use of
Poly lactic-co-glycolic-acid (PLGA) as a synthetic polymer material on which to
load growth factors to deliver directly to wounds has been shown to improve wound
healing in animal models (He et al. 2021). The main focus with developing
nanoparticle therapies is on properties which demonstrate structural similarity,
biocompatibility and biodegradability between the different polymers and skin (He
et al.
PLGA has many of these properties and is therefore one of the more
2021).
studied polymers in nano-technology. PLGA microspheres loaded with recombinant human Epidermal Growth Factor (EGF) nanoparticles showed faster
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proliferation of fibroblasts and faster healing rates when compared with PLGA and
recombinant human EGF. Similar effects have been demon strated with the use of
curcumin nanoparticle gelatin microspheres, loaded into hydrogels. There was
improved wound healing, collagen formation and neovascularisation (He et al.
2021; Liu et al. 2018).
Evidence for the Use of Technology on Offloading
Plantar pressure measurements have been shown to be useful in the design and
assessment of therapeutic footwear for high risk diabetic patients: in particular,
in-shoe plantar pressure analysis is an effective means to evaluate and guide
footwear modifications that reduce pressure in the neuropathic diabetic foot. By this
means the quality of footwear can be improved and hence, reduce the risk for
pressure-related plantar foot ulcers (Bus et al. 2011; Waaijman et al. 2012). The
offloading capability of therapeutic insoles or orthopaedic footwear can thus be
improved when guided by plantar pressure measurement and the risk of ulcer
recurrence reduced by 46–65%, assuming that the footwear is actually worn. This
has been a pivotal step forward as footwear was previously designed and assessed
on the expertise and skills of the prescribing physician and orthotist, and efficacy
was gauged according to whether a foot ulcer subsequently occurred or not.
Covid 19 Pandemic and Management of the Diabetic Foot
One concern during the pandemic, was to find a balance between reducing
unnecessary travel to hospital for foot clinic appointments, and ensuring there was
appropriate foot care for those with moderate to severe ulceration or new ulcers
requiring specialist input. The use of technology to facilitate this judgement
included mobile apps that encrypted messages and photographs with patient sensitive data. In South East London, the use of a communication app which also
allowed seamless sharing of photos and encrypted patient information was
approved through information governance in much shorter time frames than would
normally take. The roll out of the app across 5 hospitals allowed the seamless
sharing of information about clinical cases across a region where expert advice on
wound care, dressing management and decisions for surgical intervention could be
made as needed without the patient having to travel unnecessarily. It also allowed
support across community, primary and secondary care teams. Across the world,
there was a noticed reduction in visits to diabetes foot clinics with visits falling as
much as 70% in Los Angeles and 50% in Manchester UK to 29% in Argentina
(Miranda et al. 2022). The International Working Group on Diabetic Foot and
D-Foot International developed a ‘fast-track pathway’ for non-specialist health care
professionals with the aim to reduce late referrals with foot ulcers and reduce
diabetes related foot admissions to hospital (Meloni et al. 2021). It gave guidelines
60 D. Dixon and M. Edmonds
on time to see a specialist foot service with regard to severity of ulceration at
presentation. Foot in Diabetes UK (FDUK) also wrote a guidance document
stressing the importance of recognising foot and leg complications that are limb- or
life-threatening and referring them to multidisciplinary clinics which remained open
in the UK (Foot in Diabetes UK 2020).
There was a variability in technology across different countries to facilitate
telemedi
tions rather than video consultations. Despite this variability, a meta-analysis of four
controlled-trials demonstrated that treating of diabetic foot ulcers via telemedicine
was an effective alternative when face to face consultations are reduced or not
possible (Yammine and Estephan 2022). A qualitative survey in Tuscany demonstrated patient satisfaction with telemedi cine as a means to monitor diabetic foot
ulcers and would be happy for future use in monitoring the condition when needed
(Iacopi et al. 2021).
cine
revie
ws.Often
the
term
telemedicine referred to telephone consulta-
Conclusion
We have described the usefulness of technology and evidence to aid diagnosis and
management of diabetic foot ulcers. Technological advances have been made in the
diagnosis and assessment of neuropathy, which successfully permit the prediction
of ulcers but not as yet in the prevention of ulcers. Advances have been made in the
measurement of plantar pressure to facilitate the development of efficient footwear
which can reduce the risk of ulcer recurrence. Advances in the measurement of skin
temperature have permitted the early diagnosis of skin breakdown. Foot skin
temperature monitoring has prevented a first or a recurrent foot ulcer in high risk
patients, at between 65 and 75% compared with usual care. Point-of-care fluorescence imaging has aided the characterisation of infection and ulcer healing rates
have been improved.
Technological advances have been made in the treatment of ulcers and the
e ba
evidenc
trolled clinical trials. Their usefulness in real life is more difficult to gauge and
further multicentre studies would be helpful. Also, some of these technologies
especially gene therapy and nanotechnology are in the early stages of development
and research and will require further studies in the clinical arena.
Whilst the treatment of ulcers and thus the prevention of amputations may be
facilitated
to be synchronised and harmonised into an organised multidisciplinary treatment of
the diabet ic foot ulcer which embraces mechanical, microbiological, vascular and
educational aspects of care in addition to the direct treatment of the ulcer itself. It is
only then that patients will fully benefit from the impact of these technologies and
experience successful ulcer healing which is so eagerly desired but still eludes
many of them.
se for many of these technologies has been established by well con-
by individual therapeutic innovations in technology, such advances have
The Diabetic Foot, Its Complications, Role of Technology … 61
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