Hard-to-heal wounds are typically defined as wounds not progressing through the normal process of healing and which have remained unhealed for >4 weeks.1 In the US alone, these wounds impact about 10.5 million Medicare beneficiaries, with wound prevalence increasing by 13% in the five-year period from 2014–2019, especially in patients aged <65 years.2 These wounds can last on average 12–13 months, but this varies widely; many will remain open for years or never heal.3, 4 Specifically for diabetic foot ulcers (DFUs), data highlight that 48% may remain unhealed at 12 months.5 The financial costs of wound care have been estimated at up to 4% of total healthcare expenditure in the UK,6 and up to $22.5 billion for Medicare beneficiaries in the US.2 In addition, the hidden costs to individuals and their families are well documented.7 Notably, a patient with a hard-to-heal wound will often have a lower quality of life (QoL) score compared with other chronic conditions.8, 9
Living with a hard-to-heal wound disrupts nearly every aspect of a patient's life. Clinic appointments, testing, procedures and dressing changes mean that daily routines revolve around the care of the wound.
Wound odour, drainage and pain can lead to feelings of depression, anxiety and hopelessness.8, 10 Many patients experience trepidation during dressing changes or become self-conscious because of the negative stigma of living with a hard-to-heal wound. Social isolation and decreased functional capacity contribute to an overall decrease in QoL.11 Low QoL has been associated with an increased risk of morbidity. In a study by Cole-King and Harding,12 delayed healing of hard-to-heal wounds was associated with a higher mean Hospital Anxiety and Depression Scale (HAD) score13 (patients with HAD scores in the top 50% were four times more likely to have delayed healing than those scoring in the bottom 50%), highlighting the impact QoL can have on the healing process itself.
The numerous challenges of hard-to-heal wounds, such as management of comorbidities, access to treatment, consistency in care and reduced patient QoL,5, 14–16 were accentuated further during the COVID-19 pandemic, with a decrease in the number of community-based face-to-face clinician visits and fewer patient referrals to a hospital specialist.1 Concurrently, a rise in hard-to-heal wounds and increased risk of amputations were reported.17
DFUs are common, with up to 34% of patients with diabetes developing a DFU in their lifetime.18 Moreover, these wounds have a high risk of developing complications, such as infection, which can progress rapidly if not monitored closely, resulting in minor or major amputation (30% and 6%, respectively).19, 20 Even when they do heal, DFUs recur frequently, with rates ranging from 40% at one year to 65% by five years, decreasing patient QoL and increasing morbidity.18, 21 Within this cohort, 30.5% of patients will die within five years of their first DFU diagnosis.22 However, regular specialist monitoring and intervention is one of the easiest, least expensive and most effective measures for preventing these foot deteriorations and complications.22, 23
Patient apprehension, physical limitations, reluctance to visit healthcare settings due to the pandemic, logistics and/or costs have been cited as possible barriers to patient access to specialist wound care,17, 24–26 with logistics a particular issue for patients in rural communities.27, 28 Shared care encompasses approaches and interventions that may enable patients to participate in care planning, decision-making and care delivery.29, 30 This approach may help provide solutions to such challenges, where patients are included as partners in their care and treatment, and, critically, that the needs of the individual are at the core of the decision-making process.7 Even before the global pandemic, trends highlighted an increased shift towards different models of care; however, these were accelerated by need during and in recovery from the COVID-19 pandemic.7, 31 Remote tools and digital technology can be used to facilitate shared care, supporting consistency of assessment and monitoring.1, 32 These are important factors to ensure that standard of care (SoC) is maintained.23, 24, 33
Evidence-based care algorithms can be further optimised with the addition of advanced wound interventions, such as topical oxygen therapy (TOT), that can be easily used and adapted to a patient's lifestyle. TOT is advocated as adjunctive to good SoC when a hard-to-heal wound has failed to reduce in size by >40–50% within one month.34–39
This case series reports the results of a pilot programme to explore a shared care approach using a remote assessment and monitoring tool in combination with continuous TOT (cTOT) to optimise care for patients with diabetes with complex wounds.
Methods
Ethical approval
This pilot study was approved by Salem, Virginia Veterans Administration Healthcare Institutional Review Board (IRB PROTOCOL # AL 0008, 9 November 2020) and was registered on Clinicaltrial.gov (NCT04746573). It conforms to the guidelines set out in the Declaration of Helsinki. All patients included in the study consented in writing to participation in the study, which included the publication of photographs.
Patient recruitment and inclusion
All patients included in this study had been diagnosed with diabetes. There was a DFU present in seven patients and one patient had a traumatic wound. All wounds had demonstrated no visible improvement for a minimum of four weeks despite good SoC prior to enrolment. Inclusion and exclusion criteria are detailed in Table 1.
| Inclusion criteria | Exclusion criteria |
|---|---|
| Patient has hard-to-heal wound of any aetiology except for third degree burns | Patient has life expectancy of <1 year |
| No visible improvement in the previous 4 weeks | Patient is unable to manage the cTOT device |
| Wound present for ≥4 weeks but <12 months | Patient is unable or reluctant to use iPhone and imaging technology |
| Wound measures ≥1cm2 and <25cm2 | Index ulcer is 100% necrotic or if physician felt it necessary to completely cover the wound with creams or gels that would prevent the transmission of oxygen to the wound base |
| Patient is able and willing to participate in self-care | Patient has major uncontrolled medical disorder(s), such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anaemia |
| Patient is able and willing to follow protocol requirements | Patient is currently being treated for active malignant disease or patient with history of malignancy within the wound |
| Patient has signed informed consent | Patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety |
| Known contraindications to cTOT | |
| Known allergies to any of the cTOT components | |
| Known allergies to the adhesives |
cTOT—continuous topical oxygen therapy
Remote assessment and monitoring tool
An Advanced Digital Wound Care Platform-telehealth (ADWCPt) system comprising 3D Lite imaging and wound measurement application (eKare InSight Research, eKare Inc., US) was used to capture wound measurement data remotely from the patient and communicate it to the clinician. Briefly, this non-invasive app images the wound bed and converts the data instantly into measurements for area, length and width, with data available for review by the clinician in real time, helping to control the subjectivity of wound measurement.
Wound visits and assessment
The visit and assessment schedule comprised face-to-face clinic visits, remote monitoring by the patient, and telehealth/video appointments between the patient and the clinician. The schedule is detailed in Fig 1 and included the following:
Visit and assessment schedule for the study. *Wound assessment: wound image, wound measurement, wound appearance/tissue; †Wound image + simple questions (three relating to the wound and two relating to the device)
For the first four weeks of the study there was an initial enrolment and assessment visit in the clinic followed by bi-weekly onsite visits. Remote self-assessments were performed by the patient at every dressing change (minimum once weekly), which included taking a wound image using the app and answering five questions Three questions related to the patient's wound and two related to the cTOT device (NATROX O2, Inotec AMD Ltd., UK) (Fig 2) to help identify any wound or treatment adherence issues. Alerts to the clinician were triggered with additional clinic visits stipulated as appropriate if there was maceration, wound deterioration or device issues, and when questions 1–3 were answered ‘Yes’ or questions 4 and 5 were answered ‘No’ (Fig 2). The app also had a facility for the patient to ask questions of the clinician
The five questions completed by the patient prior to weekly review
For the remaining weeks (weeks 5–11), onsite clinic visits were extended to every four weeks if the aforementioned criteria were met (i.e., if no maceration, wound deterioration or device issues were noted, and when questions 1–3 were answered ‘No’ and questions 4 and 5 were answered ‘Yes’). These were supported by weekly video assessments with the clinician. Remote self-assessments continued at every dressing change (minimum once weekly) as described above. The final assessment (week 12) was performed face-to-face with the clinician in the clinic. The information in the app was triaged daily by the responsible clinician in case of need for additional intervention or support as appropriate.
For all patient assessments, wound data, including wound size and tissue appearance, were recorded in the ADWCPt system. Wound measurements were captured using a 3D Lite electronic measurement tool as part of the ADWCPt. Remote assessment and telehealth appointments were also facilitated using the ADWCPt system. Patients were given a specially configured iPhone 11 pro (Apple Inc., US), with an eKare inSight Healthcare app and an eKare Telehealth app (both eKare, US) to measure the wound and report key data as described above. The apps also contained a patient education and information library with instructions on their use, how to manage the device in both written and video format, and additional information on the therapy. The calendar was used for patient reminders to change dressings and replace the device battery. Furthermore, the wound specialist gave personalised instructions to the patient and/or caregiver about self-management of their wound depending on the individual's needs.
Baseline assessments performed on recruitment included a full wound assessment, vascular/perfusion status and medial artery calcification (MAC) score as described by Ferraresi et al.40 A MAC score of 0–1, 2–3 or 4–5 signifies no MAC, moderate MAC or severe MAC, respectively. Wound pain was recorded using a visual analogue scale (VAS) on a range of 0–10, where 0 is no pain and 10 is the worst pain imaginable. In addition, all patients completed a health status questionnaire upon enrolment and at the end of the 12-week period to understand patient qualitative status in the areas of mobility, ability to self-care, activity level, pain and discomfort, anxiety and depression, as well as a quantifiable measure of overall heath state score. At the end of the study, the patients provided feedback on remote care and the cTOT treatment device.
Treatment
Following all relevant consents, patients deemed suitable for inclusion were initiated on a 12-week treatment incorporating cTOT with SoC. Wound debridement and the use of offloading, where appropriate, were at the discretion of the wound specialist throughout the study.
The cTOT device consisted of a small, portable, batterypowered unit that generated continuous oxygen, delivered to the wound bed at a flow rate of 11ml/hour via a tube and an oxygen delivery system (Fig 3). Once positioned, this system was then covered with a secondary dressing as appropriate to manage wound exudate. Frequency of dressing changes was dictated by the wound conditions. The simple and easy-to-use technology of the cTOT device allowed patients to change the device as required at home, and to maintain full mobility during treatment. After the 12-week study period, the patients whose DFUs had not healed returned to their routine wound care specialist for treatment and were no longer followed as part of the protocol; however, these patients continued therapy.
The continuous topical oxygen therapy device (Natrox O2, Inotec AMD Ltd., UK)
Outcome measures
Primary outcome measures were the number of patients who achieved complete wound closure during the 12-week study and the percentage change in ulcer size relative to baseline measurement in 12 weeks.
A secondary outcome measure was the effectiveness of a shared care approach using remote management and telehealth measured by the change in number of face-to-face clinic visits necessary over 12 weeks, with observations around any operational efficiencies also reported. In addition, usability of the remote platform and cTOT device were recorded through patient feedback.
No statistical analysis was performed due to the pilot nature and small numbers in this study. Data will be used to demonstrate proof of concept and guide future larger trials.
Results
Patient demographics and wound information
A total of eight patients were enrolled in the study. Wound characteristics and patient demographics are shown in Table 2. Mean patient age was 67 years (range: 53–80 years), all of whom were male. All patients had diabetes which was managed with appropriate medication; two patients had type 1 diabetes and six patients type 2 (Table 2). All wounds were located on the lower extremity and were diabetic in aetiology with the exception of patient 6, a patient with diabetes, but who had a trauma wound. The wound duration prior to study enrolment ranged from 4–43 weeks (mean: 17 weeks). Pain medication for wounds was managed in the primary care setting and remained the same throughout the study.
Patient demographics, risk factors and wound aetiology
| Patien | Diabetes type/medication | MAC disease | TCPO2 <40mm/Hg | ABI | Wound | ||||
|---|---|---|---|---|---|---|---|---|---|
| # | Age, years | Sex | Aetiology | Location | Duration, weeks | ||||
| 1 | 66 | Male | 2/oral | Moderate | No | Left: 1.60 |
Diabetic | Plantar surface, left |
11 |
| 2 | 57 | Male | 2/oral | None | Yes | NC | Diabetic | Plantar surface, left | 28 |
| 3 | 53 | Male | 1/insulin | None | No | Left: 1.58 |
Diabetic | Plantar surface, right | 44 |
| 4 | 75 | Male | 1/insulin | Severe | Yes | Left: 1.10 |
Diabetic | Plantar surface, right | 17 |
| 5 | 76 | Male | 2/oral | Moderate | Yes | Left: 1.26 |
Diabetic | Plantar surface, left |
19 |
| 6 | 76 | Male | 2/oral | None | No | Left: 1.33 |
Trauma | Shin, left-proximal ankle, lower leg | 8 |
| 7 | 80 | Male | 2/oral | Moderate | Yes | Left: 1.80 |
Diabetic | Foot, left, lateral malleolus | 21 |
| 8 | 53 | Male | 2/oral | None | No | Left:1.53 |
Diabetic | Plantar surface, left |
4 |
ABI—ankle–brachial index; MAC—medial artery calcification disease; NC—not compressible; TCPO2—transcutaneous oxygen pressure
Wound outcomes
All wounds reduced in size over the 12-week period (Table 3, Fig 4). The mean percentage reduction in wound area over the 12 weeks was 92.0%. Two wounds healed completely at 10 weeks and 6 weeks for patient 3 and patient 6, respectively. In addition, patient 4, who had severe MAC disease, defined as a MAC score of 4–5, had almost complete re-epithelialisation (99.2% reduction in wound area) following cTOT treatment despite a wound duration of 17 weeks, with no significant healing before enrolment.
Wound assessment measures over the 12-week study
| Patient # | Wound aetiology | Wound area (cm2) | Pain score | Wound tissue appearance (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial | Week 12 | Initial | Week 12 | Initial | Week 12 | ||||||
| G | S | N | G | S | N | ||||||
| 1 | Diabetic | 7.1 | 0.10 | 4 | 2 | 99 | 0 | 1 | 100 | 0 | 0 |
| 2 | Diabetic | 1.7 | 0.20 | 0 | 0 | 100 | 0 | 0 | 100 | 0 | 0 |
| 3 | Diabetic | 2.1 | 0.00† | 0 | 0 | 100 | 0 | 0 | Closed | ||
| 4 | Diabetic | 1.2 | 0.01 | 0 | 0 | 100 | 0 | 0 | 100 | 0 | 0 |
| 5 | Diabetic | 1.6 | 0.10 | 4 | 2 | 99 | 0 | 1 | 100 | 0 | 0 |
| 6 | Trauma | 4.3 | 0.00* | 0 | 0 | 100 | 0 | 0 | Closed | ||
| 7 | Diabetic | 1.6 | 0.20 | 0 | 0 | 42 | 51 | 7 | 100 | 0 | 0 |
| 8 | Diabetic | 1.6 | 0.50 | 0 | 0 | 94 | 2 | 4 | 100 | 0 | 0 |
healed at 10 weeks
healed at 6 weeks
G—granulation tissue; S—Slough; N—necrotic tissue; Pain score 0–10: 0=no pain, 10=worst pain imaginable
Percentage wound area reduction at 12 weeks (n=8 patients). Dashed line—mean % reduction (92.0%)
The wound tissue was reported to have improved in four patients, with a reduction in necrotic/sloughy tissue and an increasingly granulating wound bed. In addition, for the two patients who had wound pain initially, this was reduced from a VAS score of 4 at baseline to a VAS score of 2 at 12 weeks. No adverse events, including infection or hospitalisation, were reported for any of the patients involved in the study. Furthermore, no wound issues necessitated unplanned face-to-face care. Additional in-clinic visits were only required for those patients where wound debridement was necessary.
Example cases
Patient 1 was a 66-year-old male patient with moderate MAC disease who presented with a large DFU on the plantar surface of the left foot at the first metatarsal head (Fig 5a, b). The ulcer had not been progressing for the 11 weeks before initiating on the trial. The patient was treated with cTOT, silicone wound dressing and had offloading with a controlled ankle movement (CAM) boot. Over the 12-week cTOT treatment, the ulcer size reduced by almost 99%, with the clinician reporting the ulcer would likely heal in the subsequent two weeks post therapy. The neuropathy in this patient's hands made applying the device difficult but the patient was supported by family caregivers.
Patient 1: a 66-year-old male patient with a moderate medial artery calcification (MAC) score. Case example of a complex diabetic foot ulcer managed with continuous topical oxygen therapy. Wound duration 11 weeks (a); a 99% reduction in wound area at 12 weeks (b)
Patient 3 was a 52-year-old male patient who presented with a deep DFU on the right foot plantar aspect at the first metatarsal head (Fig 5c,d). Duration of the ulcer prior to cTOT was 44 weeks, with little progression. The patient was enrolled to the study, cTOT was initiated and progress followed over the study period. The wound was covered with a self-adhesive dressing and offloading was with a knee scooter, a patellar tendon brace and custom-moulded shoes and inserts. Complete wound closure was reported at week 10.
Patient 4 was a 75-year-old male with severe MAC disease who presented with a DFU on the plantar surface of his right foot (Fig 5e,f). This ulcer had been present for 17 weeks prior to this study, despite best practice care, including an offloading boot. The patient received cTOT covered with a silicone-bordered dressing and a removable offloading walker boot. Following treatment with cTOT, the wound demonstrated 99.2% reduction in wound area in 12 weeks.
Patient satisfaction and feedback
Patient health-related scores were captured before and after the study and are detailed in Table 4, with the overall changes in score summarised in Fig 6. An overall improved patient score was demonstrated in all eight patients. Improved mobility scores during the study were reported by five patients. An improved ability to carry out their usual activities was noted by four patients. An improvement in pain and discomfort as well as anxiety and depression was reported by three patients. None of the eight patients reported a change in their ability to self-care throughout the study (Table 4). Overall, patients liked the safety, security and convenience of managing their wounds at home, stating that they felt they had better and more frequent interactions with their doctor. Patients also reported the cTOT device was easy to use (Table 5). Patient feedback reported favourably on the remote approach, allowing them to self-manage the wound and observe how the wound was progressing, balanced with less travel to the wound care clinic (Table 5).
Patient health status questionnaire scores pre- and post-intervention
| Health statements | Patient | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | ||||||||||
| Mobility | I have no problems walking about | X | X | X | X | ||||||||||||
| I have some problems walking about | X | X | X | X | X | X | X | X | X | X | X | ||||||
| I am confined to bed | X | ||||||||||||||||
| Self-care | I have no problem with self-care | X | X | X | X | X | X | X | X | X | X | X | X | ||||
| I have some problems washing and dressing myself | X | X | X | X | |||||||||||||
| I am unable to wash and dress myself | |||||||||||||||||
| Usual activities | I have no problems performing my usual activities | X | X | X | X | X | |||||||||||
| I have some problems performing my usual activities | X | X | X | X | X | X | X | X | X | X | |||||||
| I am unable to perform my usual activities | X | ||||||||||||||||
| Pain and discomfort | I have no pain and discomfort | X | X | X | X | X | X | X | X | X | |||||||
| I have moderate pain or discomfort | X | X | X | X | X | X | X | ||||||||||
| I have extreme pain or discomfort | |||||||||||||||||
| Anxiety/depression | I am not anxious or depressed | X | X | X | X | X | X | X | X | ||||||||
| I am moderately anxious or depressed | X | X | X | X | X | X | X | X | |||||||||
| I am extremely anxious or depressed | |||||||||||||||||
| Overall health-related status score | 50 | 65 | 80 | 90 | 25 | 35 | 60 | 64 | 50 | 75 | 80 | 90 | 30 | 40 | 40 | 60 | |
Score based on 0–100 scale where 100 is the best imaginable health state and 0 is the worst imaginable health state. Pre (lighter column), post (darker column)
Patients' feedback on the usefulness of the remote telehealth approach and adjunctive continuous topical oxygen therapy treatment; n indicates number of patients choosing that feedback option on the scale
| Feedback areas | Likely, n | Unlikely, n | |||||
|---|---|---|---|---|---|---|---|
| Extremely | Quite | Slightly | Neither | Slightly | Quite | Extremely | |
| Using the oxygen device enabled me to self-manage my wound | 6 | 1 | 1 | 0 | 0 | 0 | 0 |
| The iPhone and wound care app allowed me to have closer contact with my doctor | 3 | 5 | 0 | 0 | 0 | 0 | 0 |
| I had quicker access to my doctor when I experienced wound care issues at home | 4 | 3 | 0 | 1 | 0 | 0 | 0 |
| These products enabled me to gain the necessary clinical care from the safety of my own home | 6 | 1 | 1 | 0 | 0 | 0 | 0 |
| Using these products reduced the need to travel to the wound clinic | 7 | 1 | 0 | 0 | 0 | 0 | 0 |
| Using these products allowed me to see the wound progressing | 7 | 1 | 0 | 0 | 0 | 0 | 0 |
Overall patient health-related score changes before and after 12-week continuous topical oxygen therapy period
Operational efficiencies
The majority of the shared care clinical interactions in this study were remote—either by self-assessments using the patient app (n=80, 50.0%) or using video assessments with the clinician (n=27, 16.9%)—resulting in only 33.1% face-to-face interactions in clinic (n=53) (Fig 7a). This change in approach to clinical assessments resulted in a 54.0% increase in the number of clinical interactions, whereas clinical time taken was reduced by 25.8% (Fig 7b).
Clinical interactions and operational efficiencies from the hybrid care approach in this study compared with routine practice. Number and types of clinical interactions (a) and clinical time (hours) (b)
Discussion
Living with a hard-to-heal wound can be demanding and burdensome. Patients with DFUs and their caregivers consistently identify time constraints (e.g., difficulty finding available appointment times, conflicts with occupational and caregiving responsibilities), financial insecurity, mobility deficits, and lack of access to safe transportation as barriers to accessing treatment.25, 26
The management of DFUs has a considerable impact on the morbidity and mortality of the patient, and contributes to high healthcare costs. A study published in the Journal of the American Podiatric Medical Association reported that the odds of a patient receiving a diabetes-related amputation have increased by up to 10-fold since the onset of the COVID-19 pandemic.41 Disruptions in healthcare practices during the pandemic highlighted the need for alternative sites of care and the development of active patient participation programmes, with appropriate safeguards, education and technology to support patient outcomes.7, 23, 24, 31 The results of a 2021 survey noted that 43% of the responding clinicians reported wound clinic closures during the COVID-19 pandemic and those clinics that remained open experienced a 60% reduction in patient visits.42 An increase in the use of telemedicine services post-pandemic was noted among survey participants corresponding to reported national trends.42
Embracing shared care and remote patient monitoring (RPM) tools can benefit the patient and healthcare provider alike. Shared care has been shown to reduce the number of clinical hours and includes benefits such as patient education, understanding of when to raise issues or questions to the healthcare provider, improved adherence, and engagement and empowerment with care.7, 31, 32 The clinician and patient are active partners in shared care,24 helping to drive understanding and positive engagement, with feedback from both parties being an important feature in the patient journey.7, 23 In a recent US study of patients with DFUs using a remote assessment tool,23 the use of the digital wound management system triggered an early change in wound management for 36.0% of patients. In addition, patient satisfaction was high; 94.0% of patients reported that the system was useful. This correlates with the data in the present study, albeit using different systems and different assessment schedules, with 87.5% of patients stating that the system allowed them to see how the wound was progressing and that the ease of use of the therapy helped them self-manage their wound remotely.
In this study, frequent remote monitoring provided the reassurance of rapid clinical decision support, allowing the clinician to act using a video call for further information (or a clinic visit if required), catching changes in wound status sooner to decrease hospitalisation and emergency room visits. No requirements for antibiotics or hospitalisation were noted in this study, and no adverse events were reported. Furthermore, no wound issues were reported which required unscheduled clinic visits. Additional in-clinic visits were only required for those patients where wound debridement was necessary. The advantage of quicker access to caregivers was highlighted by 87.5% of patients when they experienced queries at home, such as questions about the device or video connection issues. Similar benefits were reported by Oropallo et al.33 and Keegan et al.23
Moreover, remote assessment and monitoring has the additional benefits of more efficient use of clinician time, helping to rationalise care schedules and minimise staff burnout, as seen across healthcare during the COVID-19 pandemic,43, 44 while providing more monitoring, as demonstrated in this study. Normally, managing eight patients over a 12-week study would require 104 face-to-face interactions if reviewed weekly in the clinic (equating to approximately 70 hours of clinical time). In this study, the daily triage of any alerts and communications was built into the clinical schedule with ease. More flexible remote or video interactions freed up nearly 18 hours of clinical time and >50 clinic appointments. Clinician feedback, captured from discussions at the end of the study, highlighted that documentation was simple, quick and more consistent on the digital platform, allowing them to follow wound progression with ease. Furthermore, the ability to assess wounds remotely allowed the team to focus on patients who required greater clinical input.
Over the past three decades, there has been an increase in the proportion of patients who prefer active participation in their wound care decision-making.31, 45, 46 As part of shared care, the patient's voice merges with the provider's knowledge and expertise to produce collaborative decision-making on treatment options and care plans. By imparting the best available evidence to patients, they can consider the options to achieve their specific goals based on their personal preferences. An integral part of successful shared care in wound management will encompass practice interventions, such as the use of RPM tools that facilitate interested and capable patients to take a more active role in care planning and delivery, e.g., the monitoring and changing of dressings.31
Patients want wound care that provides a quicker, less painful healing trajectory, with minimal hospital time and with wound dressings that are tailored to their individual needs.31 This was evident in the present study, with strong patient feedback on enhanced mobility in 62.5% of patients and an improved score on the ability to carry out usual activities in 50.0% of patients. This enhanced mobility combined with obvious wound progression and less time in the clinic helps cement patient engagement. Using RPM platforms can offer patients increased access to care, particularly in more rural areas. Additionally, the convenience of obtaining healthcare services from the comfort of patients' homes breaks down barriers to access and supports their overall QoL.
Active treatments help to optimise good SoC.34–36 cTOT is recognised as one of these evidence-based adjunctive treatments. Oxygen plays an essential role in multiple wound healing processes, including oxidative killing of bacteria, cellular signalling and proliferation, collagen deposition and angiogenesis.36 It follows that reversal of hypoxic conditions in any hard-to-heal wound can enable faster healing, by supporting increased demand for oxygen for tissue repair and the immune response, thus minimising barriers to healing, such as inflammation, infection and biofilm. cTOT has been reported to support faster healing across multiple studies and wound types,47–54 and provides the added advantage of at-home use and patient mobility during treatment,36 which is further verified in this study.
Moreover, cTOT has been supported by evidence-based recommendations for use in hard-to-heal wounds by an expert panel35 and new treatment guidelines (American Diabetes Association and International Working Group on the Diabetic Foot).38, 39 A randomised controlled trial of 145 patients with non-healing DFUs reported significantly higher DFU healing in patients receiving cTOT plus SoC compared with SoC alone at 12 weeks (44.0% versus 28.1%, respectively), with a mean wound area reduction with the cTOT plus SoC cohort of 70.0%.47 Comparable outcomes are reported in this observational study with two patients healed in 12 weeks and a mean wound area reduction of 92.0%. Similar patterns in healing rates and wound area reduction are also demonstrated with cTOT across other hard-to-heal wounds including venous leg ulcer and pressure ulcer,49, 55 which when combined with additional benefits, such as pain reduction, can not only help reduce analgesic use but consequently support improved patient QoL, providing a valuable adjunctive therapy hand in hand with remote care.
Limitations
Although this pilot study investigated a limited number of patients, it provides useful data to guide wider clinical adoption of remote platforms and reassurance for a shared care approach. Future studies could build on this stepchange in care delivery with direct comparisons to regular clinic-centred care across multiple sites, incorporating formalised QoL measures and other patient-related outcomes. Further comprehensive cost and resource impact analysis would allow broader adoption of this model in everyday care.
Conclusions
The management of DFUs has a considerable impact on the morbidity and mortality of the patient, and contributes to high healthcare costs. This pilot study highlights the benefits of shared care using remote assessment tools and advanced cTOT therapy in the active management of complex hard-to-heal wounds. This cohort of patients displayed positive wound healing trajectories throughout the course of the study. In addition, they received a greater overall number of wound care assessments without disruption of the clinic workflow. Office time could then be dedicated to patients needing more complex interventions while still engaging stable patients within the practice.
cTOT proved to be an effective adjunct therapy and, being a mobile technology, fitted well with use of RPM and telemedicine. Such new approaches should be considered in patients whose wounds have failed to progress using current SoC. Establishing a shared care programme that uses evidence-based advanced therapies, such as cTOT and RPM with the option of telehealth, reduced healthcare use, increased access to care, supported better patient education and adherence, produced favourable patient satisfaction, and had a positive impact on patients with DFUs.