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Introduction

Venous leg ulcers (VLUs) are chronic wounds caused by sustained venous insufficiency and venous hypertension.^1,2 They are commonly associated with factors such as varicose veins, previous deep venous thrombosis, prolonged immobility, obesity and calf muscle pump dysfunction. Diabetes, hypertension and smoking are frequently also present as comorbidities and are associated with impaired wound healing. VLUs often result in pain, reduced mobility, diminished quality of life and high rates of recurrence. These physical effects often contribute to psychological distress and, in some cases, social isolation.³ The incidence of ulceration is rising globally, driven by an aging population and the increasing prevalence of risk factors, such as smoking, obesity and diabetes. The overall prevalence is estimated at approximately 1%.^4,5

VLUs are also a significant economic burden, accounting for more than 1% of healthcare expenditures in industrialised nations, with about 78% of costs attributable to healthcare personnel visits.⁶ Although VLUs are generally expected to heal within 12 weeks, 56% remain unhealed beyond this period, and 29% persist for over a year.^7,8

Compression therapy (CT) is the standard of care for managing VLUs. It involves applying pressure to the lower leg using bandages, stockings, wraps, and other products. CT promotes ulcer healing by enhancing venous return, reducing oedema, and lowering ambulatory venous pressure.^9,10 However, in practice many patients do not receive or sustain the optimal sub-bandage pressure required for effective treatment.^11,12 Factors such as bandage application technique, patient movement, pressure loss over time, and bandage stretch or slippage can all reduce effectiveness.¹³

Moreover, limited awareness of VLUs as a symptom and complication of underlying venous disease often contributes to inadequate and suboptimal wound management.¹⁴

Recently, interest has grown in using real-time or continuous monitoring of sub-bandage pressure to ensure that compression remains within a therapeutic range.^15–17 Such monitoring may allow early identification of pressure drops and enable corrective actions, such as bandage adjustments or top-ups, so that the intended compression is sustained. However, there is limited evidence about how such real-time monitoring functions in routine clinical service settings, whether patients will adhere to its use, whether it is feasible for patients or carers to act on the feedback, and what effects might be seen on healing trajectories.

This service evaluation aimed to explore the integration of real-time sub-bandage pressure monitoring into VLU treatment, assessing feasibility, patient adherence, and clinical outcomes. Specific objectives included determining the frequency of data transmission, healing rates, and how baseline characteristics, such as wound size, duration and comorbidity profiles, influenced healing trajectories.

Methods

Service evaluation

This project was conducted as a service evaluation of an established community-based VLU care pathway incorporating real-time sub-bandage pressure monitoring. The purpose of the evaluation was to review and improve the delivery of routine clinical care within the existing service. All patients were referred by their general practitioner for standard management of VLUs. The evaluation did not involve randomisation, experimental interventions, or deviation from usual care pathways, and the pressure-monitoring device was used within its intended clinical indication as part of routine CT.

This real-world service evaluation was carried out over a ten-month period. Patients were enrolled throughout so their treatment lasted from enrolment until healing or end of the evaluation period. The evaluation aimed to determine whether incorporating pressure monitoring technology to tailor CT could improve VLUs treatment, as well as overall service delivery and patient outcomes. The project was reviewed and approved through local clinical governance processes as a service evaluation, and was confirmed through the Health Research Authority decision tool as a service evaluation. All interventions were on-label and all participants had capacity to provide informed consent and gave written consent for their de-identified clinical data to be used for service evaluation and quality improvement purposes. Data were securely stored on-site and anonymised before processing. As a service evaluation of a centre-adopted device being used as per its indications for use, no additional ethics approval was required.

Participants

Adult patients with a diagnosis of venous leg ulceration referred to the community VLU service were eligible for inclusion. Eligibility for CT was determined clinically by the assessing nurse based on ankle–brachial pressure index (ABPI), wound characteristics and patient tolerance. In cases where ABPI could not be reliably obtained due to ulcer size, toe–brachial index (TBI) measurements were used instead. A tissue viability nurse consultant was asked to review a case with low TBI where the clinical presentation appeared to contradict the vascular indices. In this case, reduced compression was initiated with close monitoring in accordance with accepted practice for mixed or uncertain vascular status. Patients were excluded if the index ulcer was of predominantly arterial, malignant, or non-vascular origin, or if CT was contraindicated.

Patients unable to provide informed consent or if they demonstrated inability to use the necessary technology for remote data transmission, and had no carers that could help, were also not suitable for this service evaluation.

Standard wound management

Wound care was delivered in accordance with guidance from Hampshire and Isle of Wight Healthcare NHS Foundation Trust, and informed by the expertise of experienced community wound care nurses. Care followed established pathways for wound bed preparation, leg ulcer assessment, treatment, and progression. All patients received a standardised wound care regimen. The affected leg was washed using a single-patient-use bowl, dried, and irrigated with a sterile solution for ten minutes. Debridement was performed when clinically appropriate and without contraindications. Barrier products, emollients and topical steroids were applied as indicated. Primary dressings were selected in line with the local wound care formulary, with off-formulary products used when clinically necessary and reviewed weekly. CT was then applied using multilayer bandaging systems.

Materials

To measure sub-bandage pressure, a CE-marked pressure monitoring technology was integrated in routine care. This technology consists of a multi-point wireless pressure sensor and associated digital platform (Tight Alright, FeelTect Limited, Ireland). The wearable sensor device was comprised of a thin, flexible sensing device, with three piezoresistive sensor regions, and a detachable, electronic transmitter device. The sensor device was affixed on top of padded comfort layers (non-compressive stockinette and polyethylene wadding) on the lateral side of the leg (Figure 1A). A compression system was then applied over the top of the sensing device, with the detachable transmitter device remaining outside the compression layers (Figure 1B). The three sensors aligned to C (mid-calf), B1 (where the Achilles tendon meets the lower calf), and B (above the ankle bone) positions on the leg. Pressure signals were wirelessly transmitted from the transmitter device to a mobile app via Bluetooth, where they were displayed in real-time. Pressure readings were then transmitted from the mobile app to a cloud database via the internet, where they were stored and remotely accessed via a web app.

 

Figure 1. A) Example of pressure sensing device (Tight Alright, FeelTect Limited, Ireland) placement on the leg over a comfort layer (non-compressive stockinette and polyethylene wadding). B) Compression bandage was then applied over it and a transmitter device connected when data was being measured.

 

The compression product used throughout the service evaluation was UrgoKTwo^® (Urgo, France). The bandages were applied by trained personnel while the pressure monitoring technology provided live digital guidance to achieve targeted pressures. These target pressures were individualised by the assessing nurse based on ABPI, patient comfort and tolerance. Pressure thresholds were adjusted over time in response to patient comfort and clinical assessment.

Interventions

Pre-enrolment wound measurements were obtained in primary care by practice nurses using digital wound measurement software (eKare Inc.) and standardised photographic protocols. All baseline images were subsequently reviewed by a trained nurse within the service, who verified and, where necessary, manually corrected the automated wound segmentation and area measurements to ensure consistency. All follow-up wound measurements were performed by trained nurses within the VLU service using the same eKare system and imaging protocol. For limbs with more than one ulcer, individual wound areas were summed to provide a total limb ulcer area for analysis. Wound healing outcomes included time to complete healing, percentage area reduction (PAR), and time to 50% area reduction.

Throughout the evaluation period, patients continued to receive their regular treatment with the addition of pressure monitoring to assess service delivery quality, including routine visits for wound cleaning, debridement, and dressing. Wound sizes were tracked using specialised software to process photos of the wounds (eKare Inc, Fairfax, VA). Compression was applied to patients using multi-point wireless pressure monitoring technology. Pressure data were remotely transmitted and stored on the cloud database. Healthcare professionals transmitted data before compression removal and after compression application, while patients and/or informal carers transmitted data at least once a day. In order to control for potential variability caused by leg positioning, all pressure recordings were taken while the patients were standing.

Compression was applied using the pressure monitoring technology to display and guide targeted pressures. All compression bandaging and pressure monitoring were performed by registered nurses trained in multilayer CT and in the application of the pressure monitoring system. The pressure sensor was affixed to a stockinette layer on the lateral aspect of the leg and aligned to three standard anatomical landmarks. Nurses completed a one-day practical training session with competency assessment. During bandage application, sub-bandage pressures were visualised in real time, allowing the nurse to verify achieved pressures and adjust or reapply the bandage as necessary to reach predefined target ranges. Sensor position and function were visually checked at each clinic visit. Minor bandage slippage did not result in data loss or recording artefacts, as the system does not require precise sensor positioning to assess sub-bandage pressure trends. Compression thresholds were determined by the assessing nurse based on vascular assessment (ABPI or TBI where indicated), clinical examination, and patient tolerance. In patients with lower or uncertain vascular indices, or in those reporting discomfort, compression was initiated at reduced levels (approximately 20mmHg) and reviewed at subsequent visits, with gradual escalation if tolerated. In patients with adequate vascular status and good tolerance, higher compression levels were applied initially. Compression thresholds were reviewed and adjusted throughout treatment in response to patient comfort and clinical assessment. In addition to this, as part of routine care, selected patients or carers were trained to perform compression top-ups to maintain therapeutic sub-bandage pressure between scheduled visits. Top-ups were not required for participation, and patients who were unable to perform them safely and did not have a suitable carer were not asked to do so. An individualised low-pressure threshold was set by the assessing nurse based on vascular assessment, patient comfort and tolerance. Patients and carers were instructed to check their compression at least once daily and, if pressure fell below the prescribed threshold, to apply a single additional bandage layer while observing real-time pressure feedback until the target range was restored. Training consisted of a practical demonstration and supervised practice during the initial clinic visit, supported by written guidance. Sensor position and function were reviewed at each follow-up visit, and patients were advised to contact the service in case of discomfort, bandage slippage or abnormal readings.

Data collection

Pressure values achieved during bandage application were recorded. Patients were instructed to transmit data at least once daily. For each wound, the daily percentage reduction in wound area was calculated. Adherence to service delivery protocols and overall time to healing were also assessed.

Adverse events and device-related issues were prospectively monitored throughout the evaluation period. No adverse events or serious adverse events related to CT or pressure monitoring were recorded.

Continuous variables are presented as mean±standard deviation. Healing trajectories and time-to-event outcomes are presented descriptively. For limbs not fully healed by the end of the evaluation period, approximate healing times were estimated by linear extrapolation from recent wound area measurements (last six measurements), these estimates are presented for illustrative purposes only.

Results

A total of 17 VLU patients (23.5% male, 76.5% female) received CT treatment through our service during the evaluation period, with six patients having bilateral wounds, providing a total of 23 affected limbs treated in the evaluation (Table 1). The average age of patients was 74.2 years, with a mean BMI of 32±8.4kg/m², with nine patients in the obese range (BMI≥30).¹⁸ Ulcer duration before enrolment varied widely, with a mean of 15.1 months (range 3–84 months), while initial wound size ranged from 0.2cm-squared to 495.4cm-squared (median 8.3cm-squared), reflecting marked heterogeneity. The majority of patients had comorbidities such as diabetes (n=8, 47%), hypertension (n=12, 71%), compromised blood supply (n=3, 17%) or infection (n=2, 12%). These characteristics reflect the clinical heterogeneity typical of patients managed in routine community-based VLU services. Diabetes, hypertension, smoking history and other cardiovascular conditions were recorded as comorbidities due to their known association with delayed wound healing and poorer outcomes in chronic leg ulcers, rather than as causal factors for venous ulceration.⁸ References to “compromised blood supply” reflect general practitioner referral observations rather than confirmed diagnoses, and no patient showed clinical signs of peripheral arterial disease on examination.

 

Table 1. Patient data organised by treated limb. ABPI was used as the primary vascular assessment where feasible. TBI was measured in two patients where ABPI was not reliable due to ulcer size. “Compromised blood supply” denotes referral observations and does not equate to a confirmed diagnosis of peripheral arterial disease. BMI=Body Mass Index; ABPI=Ankle Brachial Pressure Index; TBI=Toe-Brachial Index.

 

Pressures applied

Patients averaged 1.71±0.47 data transmissions per day, reflecting high adherence to the service, which requested at least one transmission per day. Table 2 shows the average pressures applied to each limb throughout the whole treatment. All patients completed the evaluation period, and no pressure-monitoring data were lost due to device failure or sensor displacement.

 

Table 2. Sub-bandage pressures (mmHg) recorded in three anatomical positions (C, B1, B) for 23 affected limbs, with overall averages shown. Data are presented as mean±SD.

 

Across the 23 treated limbs, mean sub-bandage pressures were within the therapeutic range, with overall averages of 39.85±6.32mmHg at position C (calf), 41.22±6.58mmHg at B1 (gaiter), and 39.95±7.09mmHg at B (ankle), giving a total average of 40.34±6.15mmHg. While most limbs achieved pressures between 35 and 50mmHg, considerable variation was noted, with some patients requiring lower target pressures (for example limbs 8, 14 and 18, were all <30mmHg), typically due to patient comfort or arterial considerations. Conversely, some limbs tolerated higher pressures (>50mmHg) without reported discomfort (for example limbs 2 and 6). This variation reflected the service’s approach of tailoring compression to individual tolerance and clinical presentation.

Figure 2 provides two illustrative cases, in one patient (Figure 2A), a lower-profile system with reduced padding and lower initial pressures was selected to facilitate acclimatisation, with no top-ups requested during the first visits; as the patient adjusted, pressures were gradually increased, and the patient was eventually able to perform their own top-ups when pressures fell below 40mmHg. In contrast, another patient (Figure 2B) initially tolerated higher pressures but started experiencing claudication at nighttime; in this case, target pressures levels were reduced to maintain therapeutic benefit while ensuring comfort.

 

Figure 2. Pressure readings of two representative patients for their whole treatment. Each bar is the average of all pressure recorded at one location between visits. The line connected dots represent the total average between all three sensor locations. A) Showcases a patient who started treatment with low pressures and after a period of acclimatisation they were increased to the target range of 40-60 mmHg until healing. B) Showcases a patient who started with high pressures and had it lowered due to discomfort.

 

Out of the 17 patients seen in the service, ten (59%) applied compression top-ups over their bandages when the pressures dropped below a threshold define by their nurse. This additional bandage was applied either by themselves or their carer. They received training on how to do a top-up by their nurse, and if they were willing and capable to do it, they were instructed to apply a top-up bandage if they saw that pressure had dropped below a threshold during a daily pressure check. They would then carefully apply the additional bandage over the section of the leg required while watching the real-time pressure measurements to achieve the targeted pressure values once again. No adverse events or device-related complications were associated with patient- or carer-led top-ups. Minor bandage slippage occurred in some cases during routine wear. However, sensors remained securely positioned beneath the bandaging system, and no data were excluded due to sensor displacement.

Healing rates

Out of the 23 limbs treated seven had more than one ulcer. For these limbs, wound areas were aggregated to represent total limb ulcer burden. Initial wound size exhibited substantial heterogeneity (mean 56.07±111.60cm-squared), reflecting a wide spectrum of injury severity. Nineteen of the 23 limbs healed completely during the evaluation period, in an average time of 58 days, and only four remained unhealed with residual wounds, final wound size of 0.23±0.83cm-squared, indicating a near-complete closure across the sample. Treatment duration varied considerably (mean 72.83±45.67 days), correlating with initial wound burden and complexity. The mean time to 50% area reduction was 21.57±12.43 days.

PAR at four, eight, and twelve weeks was 71.79 ± 24.43%, 89.17 ± 14.51%, and 96.14 ± 8.72%, respectively (Table 3). Notably, several limbs achieved more than 90% PAR within the first four weeks, while others showed slower rates of closure, as reflected in the wide standard deviations (Figure 3).

 

Table 3. Summary of wound healing outcomes for 23 limbs, showing initial and final wound size, number of open wounds, treatment duration, percentage area reduction (PAR) at various time points, and daily PAR. Data are presented as mean ± standard deviation where applicable.

 

Figure 3. Percentage area reduction evolution at four, eight and twelve weeks of treatment for all patients.

 

This heterogeneity was further emphasised in the PAR per day metric (mean 1.95±1.38%/day), which had a high variability between limbs, indicating that healing rates were strongly dependent on wound characteristics rather than treatment duration alone. Limbs with larger wounds or multiple wound sites tended to require longer treatment durations, whereas smaller wounds achieved closure more rapidly.

All patients were receiving CT prior to enrolment, with the exception of one individual who was initially unable to tolerate compression because of pain. Pre-enrolment wound trajectories were estimated from wound measurements taken two weeks prior to enrolment and at the first service visit. As these estimates were derived from only two measurements per patient, they provide a limited indication of pre-enrolment healing trajectory. Nevertheless, the pre-enrolment wound size measurements showed a negative mean PAR (–2.43±6.70%/day), indicating that several wounds were enlarging before entering the service, yet all of them subsequently responded with progressive healing following enrolment (Figure 4).

 

Figure 4. Comparison of mean percentage area reduction per day before and after patients entered our service evaluation, with error bars representing standard deviations.

 

Figure 5 shows the comparison of wound healing durations before and after patients entered the evaluated treatment service. For limbs not fully healed by the end of the evaluation period, approximate healing times were estimated by linear extrapolation from recent wound area measurements (last six measurements), these estimates are presented for illustrative purposes only. Overall, most patients showed a substantial reduction in healing time after joining the service compared with how long they have had their wounds for. Most patients showed shorter healing durations following entry into the service compared with the reported duration of their ulcers prior to enrolment.

 

Figure 5. Comparison of wound healing durations before and after entry into the evaluated treatment service. Each horizontal bar represents an individual patient, showing the previous duration reported or for how long they have had the ulcers (red), treatment duration (teal), and approximate duration for those patients who did not heal at the end of the service evaluation for illustrative purposes only (grey). The majority of patients demonstrated substantially shorter healing durations under the treatment service compared with their prior healing times.

 

These findings indicate that the treatment was associated with a high rate of wound closure, with faster healing observed in smaller and more recent ulcers, while larger, chronic, or comorbidity-burdened wounds required longer treatment durations to heal. Figure 6 illustrates the baseline heterogeneity in wound size, duration, and comorbidities seen in this service evaluation, by showing two patients with very different initial wound sizes. Consistent with overall trends, smaller and more acute ulcers demonstrated more rapid healing, whereas larger or more complex wounds healed more slowly and, in a small subset of cases, remained incompletely healed by the end of the study, although they continued to show progressive improvement. This variability underscores the importance of individualised monitoring and tailored optimisation of treatment duration in clinical practice.

 

Figure 6. Ulcers from two different patients showcasing the heterogeneity in wound size and healing response among patients. The top panels show a 15.3cm-sq ulcer that fully healed in 115 days, while the bottom panels depict a ~500 cm-sq ulcer reduced to 3.9cm-sq after 205 days. Although not completely healed, the larger wound showed marked improvement during treatment.

 

Discussion

Compression is widely recognised as the most effective treatment for VLUs, significantly accelerating healing and reducing recurrence when applied effectively.² However, the efficacy of CT depends heavily on the skills of the individual applying the bandage. In clinical practice, uncertainty often exists about whether sub-bandage pressure is maintained within the therapeutic range. This challenge has driven interest in objective measurement tools, which can improve both confidence and competence in compression application.

This service evaluation shows that integrating real-time sub-bandage pressure monitoring into CT for VLU is both feasible and well accepted by patients. Adherence to the monitoring protocol was high, with an average of 1.71 pressure transmissions per day, exceeding the minimum requirement of one daily transmission. This level of engagement suggests that patients found the technology intuitive and were motivated to actively participate in their own wound management. Importantly, our treatment included an opportunity for patients or carers, who demonstrated competence, to perform pressure-guided bandage top-ups when pressures fell below a threshold defined by their nurse, by applying extra bandage around the area. More than half of patients engaged with this strategy without any associated adverse events. This shows that with appropriate training and real-time pressure feedback, selected patients and carers can real-time pressure feedback, selected patients and carers can safely support maintenance of therapeutic compression between clinical visits. This aligns with current trends in healthcare towards supported self-management in chronic conditions and may be particularly relevant in VLU care, where sustaining effective compression is both essential and difficult to achieve consistently in routine practice. However, further evaluation in larger, controlled studies is needed to determine their impact on healing outcomes.

Baseline heterogeneity in wound size, duration, and patient comorbidities reflected the complexity of typical VLU populations.¹⁹ Real-time pressure monitoring was used to tailor the treatment for each patient taking into account their comorbidities or personal difficulties. Thus, despite mean sub-bandage pressures falling within recommended therapeutic ranges, substantial variability was observed between limbs. Some patients tolerated higher pressures, while others required lower levels due to comfort or vascular considerations. Real-time monitoring enabled dynamic adjustment, rather than assuming sustained therapeutic delivery from a prescribed bandage system alone. Pressure monitoring also enabled safe treatment in a patient with borderline vascular indices but no clinical signs of arterial disease. Reduced, reliably measured compression was initiated and tolerance closely monitored, allowing healing to progress, showing the importance of combining accurate pressure measurement with clinical judgement rather than relying on threshold values alone.

Several wounds were deteriorating prior to enrolment, with negative healing trajectories observed in the two weeks before entering the service. Following initiation of CT guided by real-time sub-bandage pressure monitoring, these wounds transitioned to sustained healing. Although this comparison is vulnerable to confounding factors, the shift from wound expansion to contraction highlights the possibility of inadequate or inconsistent compression delivery in routine practice.

As expected, smaller and more recent ulcers tended to heal more rapidly, while larger, chronic wounds or those in patients with significant comorbidity required longer treatment.²⁰ However, all patients, including those with diabetes or reduced ankle mobility, improved substantially during the service. Notably, despite large wound size and prolonged duration, both key predictors of delayed healing, consistent improvements were observed, suggesting that continuous monitoring of therapeutic compression may reduce the variability typically seen in VLU outcomes. Clinical outcomes were encouraging across all patients. Wound size was substantially reduced, with a mean PAR of 71.8% at four weeks and 96.1% by 12 weeks; and 19 of 23 limbs completely healing during the service period, with a mean healing time of 58 days for those patients that healed. The majority of ulcers had an early response to the treatment, with 82.6% of limbs reaching at least 50% area reduction by four weeks. When compared with published data, the healing trajectories reported were higher. The mean daily PAR of 1.95% observed in this cohort is higher than rates reported in trials of standard or device-assisted CT.²¹ Previous studies of VLUs report closure rates of approximately 57% at 12 weeks,²² whereas this service achieved both faster early reductions and higher closure rates, with 82.6% surpassing the threshold of 50% PAR at four weeks. This threshold is clinically relevant, as failure to achieve 50% PAR at four weeks has been described as a strong predictor of non-healing by 12 weeks.²³ These results therefore suggest that real-time sub-bandage pressure monitoring, by helping to maintain therapeutic compression, may increase the likelihood of successful wound closure.

A small number of limbs did not achieve complete healing within the evaluation period, typically those with large baseline wound size, prolonged ulcer duration, or uncertain vascular status. In these cases, residual wound areas continued to decrease, indicating delayed rather than failed healing within the finite observation window.

Given the existing variation in VLU care with underuse of evidence-based practice and continued reliance on ineffective approaches,²⁴ strategies to improve compression delivery are urgently needed. Evidence suggests that CT, physical activity, health education and self-care are the most effective measures to prevent recurrence and improve outcomes.²⁵ In this context, real-time pressure monitoring could be a promising tool that can be integrated into routine VLU care to support consistent compression delivery, accommodate inter-patient variability, and manage clinical complexity.

Limitations

This study has several limitations that should be considered when interpreting the findings. First, this was a service evaluation conducted within routine clinical practice rather than a controlled research study. The observational design, absence of randomisation, and lack of a contemporaneous control group mean that causality cannot be established, and improvements in healing trajectories cannot be definitively attributed to the use of real-time sub-bandage pressure monitoring. Comparisons with pre-enrolment wound progression and with published data should therefore be regarded as descriptive and hypothesis-generating.

Aggregating wound areas may mask heterogeneity between individual ulcers of differing size or chronicity, particularly in limbs with multiple wounds. However, we believe that limb-level analysis most accurately reflects routine clinical practice and the service-level objective of restoring skin integrity to the affected limb. Estimation of healing times for limbs that had not fully healed by the end of the evaluation period relied on linear extrapolation from recent wound measurements. These projections are inherently uncertain and were included for descriptive purposes only. In addition, pressure targets were individualised based on clinical assessment, vascular status, and patient tolerance, which, while appropriate for routine care, limits standardisation across participants.

Future research should focus on larger, controlled studies to validate these preliminary findings, determine cost-effectiveness, and identify which patient subgroups benefit the most from it. If confirmed, this treatment model could contribute to a more personalised, evidence-based pathway for VLU care, improving healing rates while promoting long-term prevention and self-management.

In addition, two co-authors (MVM and GPD) are affiliated with FeelTect Ltd, the manufacturer of the pressure monitoring device used in this study, while KO is currently employed by the company but was not affiliated with it during the service evaluation. Although this represents a potential conflict of interest, steps were taken to minimise bias. All wound area and pressure measurements were obtained using objective, automated software, and data analysis was independently verified by the clinical team.

Conclusion

This service evaluation showed that integrating real-time sub-bandage pressure monitoring into CT for VLUs is both feasible and well accepted by patients. The service demonstrated high adherence, active patient and carer engagement and encouraging healing outcomes when compared descriptively with published reports. By enabling bandage top-ups when compression fell below a patient specific threshold, consistent delivery of evidence-based compression was achieved, a critical determinant of VLU healing and recurrence prevention.

Acknowledgements

The authors wish to thank the nursing staff at Home Wound Care UK, particularly Sally Turner, Michelle Small, and Liz Hawes, for their dedication in delivering care and supporting the patients who participated in this service evaluation.

Conflict of interest

GPD is a co-founder of FeelTect Ltd. MVM serves as the Clinical Engineer at FeelTect Ltd. KO is currently employed by FeelTect Ltd, but was not affiliated with the company at the time this service evaluation was conducted. DH declares no conflicts of interest.

Ethics statement

This service evaluation was conducted following an internal governance review by our institutional ethics committee and was confirmed as a service evaluation using the Health Research Authority decision tool. All interventions were performed in accordance with approved indications, and all participants provided written informed consent for the collection of their data. Data were stored securely on-site and anonymised prior to analysis. As this work involved evaluating a centre-adopted device used strictly within its intended purpose, no additional ethical approval was required.

Funding

This study was funded by FeelTect Ltd, the company that developed the wireless sub-bandage pressure monitoring device used in this evaluation.

Author contribution

KO: Conceptualisation, methodology, investigation, data curation, writing (review & editing). MVM: Software, formal analysis, writing (original draft). GPD: Conceptualisation, writing (review & editing). DH: Conceptualisation, Methodology, supervision, writing (review & editing). All authors read and approved the final manuscript and agree to be accountable for all aspects of the work, ensuring that questions regarding accuracy or integrity are appropriately investigated and resolved.

Author(s)

Karen O’Rourke¹, Manuel Villegas-Martinez², Garry P Duffy^3,4, Daphne Hazell¹*
¹Home Wound Care UK, Bognor Regis, United Kingdom
²Feeltect Ltd, Galway, Ireland
³Anatomy and Regenerative Medicine Institute (REMEDI), School of Medicine, University of Galway, Galway, Ireland
⁴CÚRAM SFI Research Centre for Medical Devices, University of Galway, Galway, Ireland

*Corresponding author email daphne@homewoundcare.co.uk

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