Volume 27 Number 2

Key messages

• Optimal sub‑bandage pressure is often difficult to achieve in practice.
• Pressure monitoring supports the delivery of compression tailored to each patient’s needs.
• Connected pressure‑monitoring systems enhance both the consistency and effectiveness of compression therapy.

Introduction

Venous leg ulcers (VLUs) are chronic wounds that develop in the lower leg due to venous insufficiency. This condition arises from mechanisms such as venous valve dysfunction, deep vein occlusion and impaired calf muscle function, which in turn can lead to venous hypertension.^1,2 The resulting ulcers not only cause pain and increase the risk of infection but can also exude odour and severely impair sleep, mobility and overall quality of life.³ These physical symptoms often lead to psychological distress and, in severe cases, social isolation.⁴ Furthermore, the incidence of ulceration is increasing globally, driven by an aging population and the growing prevalence of risk factors for atherosclerotic occlusion, such as smoking, obesity, and diabetes. The overall global prevalence is estimated to be around 1%.^5,6

VLUs also represent a significant economic burden, accounting for over 1% of healthcare expenditures in industrialised countries. Notably, around 78% of these costs are associated with healthcare personnel visits^.7,8 Although these ulcers are generally expected to heal within 12 weeks, 56% remain unhealed beyond this period, and 29% persist for more than a year.^9,10

Compression therapy (CT), which consists on applying pressure to the lower leg using bandages, stockings, wraps and other products, is widely recognised as the primary treatment for VLUs. By applying external pressure on the superficial veins and tissues, CT promotes proper blood flow and venous return, thereby addressing the underlying venous insufficiency.^11,12 Current guidelines highlight that healing rates are strongly correlated with the sub-bandage pressure¹³, indicating that a higher pressure could lead to improved healing outcomes. Clinical studies have also reinforced this idea, showing that higher compression pressure (>45mmHg) increases the proportion of VLUs healed^{14, 15} regardless of age.¹⁶ However, it is also critical that compression pressures are not excessive, which can risk the impairment or occlusion of arterial flow and thereby cause tissue damage or necrosis.

Despite its efficacy, applying and maintaining consistent pressure during CT is challenging due to patient variability, the absence of accurate pressure feedback mechanisms in compression products, and a shortage of trained personnel. Consequently, it has been reported that the targeted pressure is achieved only about 10% of the time by trained practitioners,¹⁷ and factors like swelling reduction and patient non-compliance can reduce sub-bandage pressure and further compromise CT’s effectiveness.^4,18 Indeed, previous investigations into CT’s effectiveness are often limited by methodological shortcomings in evaluation of the underlying mechanisms of action. Many comparative studies between CT materials lack the measurement of compression pressure and associated reporting of static stiffness assessments, key metrics for describing compression performance.¹⁹ This lack of insight into the sub-bandage pressures achieved during clinical investigations is a problem for optimisation of products and practices within the CT field, as compression is often applied with significant variability.²⁰ One study found that even expert nurses applied bandages with pressures ranging from just a few millimetres of mercury (mmHg) to over 140mmHg, despite an intended pressure of 50–60mmHg.¹⁷ Such inconsistencies not only raise concerns about the reliability of studies that fail to report actual compression pressures, but also highlights the likelihood of significant variability in treatment received by patients in clinical practice. Since compression pressure acts as the “dosage” of CT, accurate measurement is essential to ensure consistent application of treatment that is currently known to promote VLU healing, and to allow for optimisation of the patient’s care.

To improve both research reliability and treatment effectiveness, a promising solution is the integration of sensor technology within CT products, which can monitor pressure at various points and track patient compliance in real time.^21,22 These sensors could provide immediate feedback on compression performance, help ensure proper application, and detect non-compliance by identifying gaps in recorded data. Furthermore, by elucidating relationships between pressure and healing on an individual patient basis, in real-time, this technological advancement could significantly improve CT research quality and lead to better patient outcomes by creating tailored treatment approaches.¹⁹

Given the challenges associated with applying and maintaining targeted compression pressure and the variability in current CT practices, this service evaluation assessed whether implementing a multi-sensor pressure monitoring technology within routine service delivery could support more accurate of CT, help maintain the targeted pressure levels, and potentially improve healing outcomes in a real-world setting.²³ This evaluation uses a previously described treatment design that allows for internal controls within each patient receiving the service.²⁴

Methods

Service evaluation

This is a real-world service evaluation following the treatment of six patients with VLUs, to assess whether the integration of pressure monitoring technology could improve CT service delivery. The evaluation design included two sequential treatment phases of equal duration (either two or four weeks), namely unguided standard of care (SoC) phase and guided SoC with pressure monitoring phase. This service evaluation was carried out after an internal governance review by our in-house ethics committee, and was confirmed through the Health Research Authority (HRA) decision tool as a service evaluation, not research, which means external ethical approval was not required. All interventions were on-label and all patients gave written informed consent for data collection. 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 ethics approval was required.

Participants

Participants were six patients with chronic VLUs who were referred to Home Wound Care, a healthcare service that provides specialist CT treatment to patients with VLUs. Suitable participants were adults with a wound duration between six weeks and five years and a wound area between 5 and 100cm-squared. Eligibility for the service also required participants to be prescribed and eligible for CT, with an ankle brachial pressure index (ABPI) between 0.8 and 1.3.

Patients were not suitable for this service evaluation if they had conditions that could affect our assessment of routine service delivery, including the presence of uncontrolled diabetes (haemoglobin A1c (HbA1c) >60mmol/mol or 7.6% in the last 3 months), active infection in the index ulcer requiring systemic antibiotics at the time of inclusion, or renal failure. Patients with exposed structures such as tendon, ligament, muscle, or bone in the index ulcer were also not suitable, along with specific infections or conditions affecting the affected limb, including osteomyelitis, cellulitis or gangrene. Patients with a history of amputation above a defined level in the affected limb or those with active malignancy affecting the affected limb were not suitable for the service. Ulcers of arterial origin, based on ABPI measurement, were excluded, as well as those patients who had recent or planned vascular procedures.

Patients unable to provide informed consent or if they demonstrated inability to use the necessary technology for remote data transmission were also not suitable for this service evaluation.

Materials

To measure sub-bandage pressure as part of this service evaluation within routine care, a CE/UKCA-marked pressure monitoring technology was used strictly within its approved indications for use. 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 inserted within a padded adhesive sheath and 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 further 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); sensor may be positioned on either the lateral or medial aspect of the leg depending on clinical context. B) Compression bandage is then applied over it and a transmitter placed when data was being measured.

 

The compression products used throughout the service evaluation included Actico^® (L&R, Germany) and UrgoKTwo^® (Urgo, France). These products were applied according to the manufacturers’ instructions (during the SoC phase) or with the pressure monitoring technology providing live digital guidance to achieve targeted pressures (during the guided SoC phase). Target pressures were between 40 and 60mmHg at all three sensor positions.

Interventions

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 automatically measured using specialised image-analysis software (eKare Inc., Fairfax, VA), eliminating the need for blinded wound assessors. Compression was applied to patients according to the service delivery phase, according to manufacturer’s guidelines during unguided SoC, and using pressure monitoring technology during guided SoC. Across all stages of treatment, 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 once or twice daily. In order to control for potential variability caused by leg positioning, all pressure recordings were taken while the patients were standing.

Unguided standard of care phase: Compression was applied as per standard practice with pressure readings recorded by the pressure monitoring technology using a blinded version of the mobile app. Data was remotely transmitted to the cloud database without displaying real-time values at the point-of-care, avoiding influencing the clinician’s application technique or the patient’s perception of compression.

Guided standard of care phase: Compression was applied using the pressure monitoring technology to display and guide targeted pressures. When safe and practical, a loss of pressure below the targeted level at the B position (<40mmHg), as identified during routine data transmissions, resulted in a reapplication of compression to original targeted pressures, prior to routine wound treatments.

Data collection

The daily percentage wound area reduction was calculated for both the unguided and the guided SoC phases.^25,26 Additionally, the proportion of targeted pressures achieved during bandage application, the relative duration for which pressures remained within the target range, percentage pressure loss during therapy, and adherence to service delivery protocols were also measured.

A mixed-effects model was used to compare guided versus unguided pressures across all patients. This approach was chosen to account for repeated measures and intra-patient correlation, making full use of all available data.

Results

Six VLU patients (50% male, 50% female) received CT through our service during the evaluation period, with one patient (limb 5 and 6) having bilateral wounds, providing a total of seven treated VLUs in the evaluation (Table 1). The average age of patients was 75.3 years, with an average wound size of 7.4cm-squared, and an average wound duration of 29.6 months. Patients had a range of co-morbidities. Two patients (limb 2 and 4) completed their treatment before the guided SoC phase and were therefore excluded from wound measurement analyses.

 

Table 1. Demographic and clinical characteristics of venous leg ulcer cases.

 

Pressures applied

Patients averaged 1.78±0.07 data transmissions per day, reflecting high adherence to the service, which requested two transmissions per day (morning and afternoon). Figure 2 presents the pressure values recorded over time for a representative patient, demonstrating a greater proportion of recorded pressure values within the targeted pressure range (40–60mmHg) in the unguided SoC phase compared to the guided SoC phase.

 

Figure 2. Representative case of pressure measurements recorded by a patient. Each dot corresponds to an individual pressure value, demonstrating that measurements were consistently taken almost daily. The solid black vertical line indicates the transition from the unguided to the guided SoC phase in the treatment process. Additionally, the dashed vertical lines represent each instance of a healthcare professional’s visit and bandage replacement, while the shade regions represent the targeted range of pressure (40–60 mmHg). Abbreviation: SoC=standard of care.

 

Pressures during bandage application

Table 2 shows the average pressures recorded during bandage application by nurses for each limb, comparing compression values for both phases evaluated across all sensor locations.

 

Table 2. Average pressure values (mmHg) measured during nurse-applied bandage changes under unguided SoC and guided SoC phases. Values are reported for each sensor location (B, B1 and C positions). Values are mean ± standard deviation (SD). *P<0.05; ** P<0.001 comparing corresponding unguided and guided SoC phases results.

 

During compression application, achieved pressures were significantly higher across all sensor regions during the unguided SoC phase, compared to the guided SoC one (Figure 3A). These findings demonstrate that guided bandage application consistently achieved higher pressures compared to the unguided approach (B, p<0.001; B1, p=0.007; C, p<0.001). Furthermore, the proportion of pressure readings within the target range of 40-60mmHg improved from 39% to 66%, while the percentage of readings below the target (<40mmHg) decreased from 53.2% to 15.7% when changing from the unguided to the guided SoC phase (Figure 3B).

 

Figure 3. A) Boxplots comparing pressure values across all three sensor positions during each bandage change for all seven limbs, distinguishing between unguided SoC (grey) and guided SoC phases(white). Asterisks (*) indicate statistically significant differences with a p-value <0.05. B) Stacked column chart illustrating the percentage distribution of applied pressure during bandage changes under both phases. Pressure values are categorised as in range (40–60 mmHg), below range (<40mmHg), or above range (>60mmHg). Abbreviation: SoC=standard of care.

 

Pressures during entire treatment

Table 3 presents the average pressures recorded at each sensor location for each patient over the full duration of both unguided and guided SoC phases.

 

Table 3. Pressure values (mmHg) measured throughout the whole unguided and guided SoC phases to assess pressure consistency and changes over time, beyond the initial bandage application. Values are reported for each sensor location (B, B1 and C). Values are mean ± standard deviation (SD). *P<0.05; ** P<0.001 comparing corresponding unguided and guided SoC phases results.

 

Over the entire service period, including bandage applications and periods in between, and across all locations, guided SoC produced significantly higher pressures compared to unguided SoC (B, p<0.001; B1, p<0.001; C, p<0.001). The increase was largest at location B (~13mmHg) and smallest at location C (~5mmHg) (Figure 4A). In the unguided SoC phase, average pressures at every sensor location fell below the target range, whereas in the guided phase they consistently stayed within it. This difference appears clearly in the percentage of readings within the target range (Figure 4B): only 26.6% of measurements met the goal in the unguided phase, compared with 58.2% in the guided phase. At the same time, readings below the target decreased from 68.6% in the standard phase to 32.6% in the guided phase.

 

Figure 4. A) Boxplots comparing pressure values across all three sensor positions throughout the whole treatment for all seven limbs, distinguishing between unguided SoC (grey) and guided SoC phases(white). Asterisks (*) indicate statistically significant differences with a p-value < 0.05. B) Stacked column chart illustrating the percentage distribution of sustained pressure throughout the treatment under both phases. Pressure values are categorised as in range (40–60mmHg), below range (<40 mmHg), or above range (>60mmHg). Abbreviation: SoC, standard of care.

 

Wound healing

Wound healing outcomes within the service were evaluated in five of the seven limbs, as two patients (limb 2 and 4) completed their treatment prior to transitioning to the guided SoC phase. Among the remaining patients receiving the service, 80% saw an increase in healing rate (percentage wound area reduction per day, PAR/day) when pressure monitoring was used for feedback when applying CT (Table 4).

 

Table 4. Wound size (cm-sq) and percentage area reduction (PAR) data for each limb. Values are mean ± standard deviation (SD).

 

An exploratory analysis of wound size evolution across the service delivery phases suggested that during guided SoC, where CT was supported by real-time pressure monitoring, the average percentage area reduction (PAR) per day increased from 1.31% to 2.30% (Figure 5). While this pattern was observed in most patients, variability was high and results were influenced by individual cases (Figure 6); therefore, these findings should be interpreted cautiously as hypothesis-generating rather than conclusive.

 

Figure 5. Bar plot comparing the percentage area reduction per day between the unguided SoC (grey) and the guided SoC (white) phases. Error bars represent the standard error of the mean. Abbreviations SoC, standard of care.

 

Figure 6. Wound size trajectories during unguided and guided compression therapy. Each subplot represents an individual patient. Wound size (cm-sq) is plotted against treatment day, with unguided compression shown in red (negative days) and guided compression in blue (positive days). Day 0 (dashed vertical line) marks the transition from unguided to guided compression.

 

Discussion

CT is widely recognised as a foundational treatment for managing lymphatic and chronic venous diseases. Despite its well-documented benefits, service providers often face significant challenges in defining the dosage and/or the regimen of CT. This can result in an inconsistent pressure delivery which could translate into poor CT’s efficacy across diverse patient populations and clinical scenarios.¹⁹

Another obstacle to advancing CT delivery is the insufficient knowledge and practical expertise of both healthcare professionals and non-clinical users who administer it. Studies have shown that inadequate training in the selection and application of compression materials can lead to suboptimal outcomes, such as delayed wound healing and reduced patient satisfaction. Even experienced clinicians often find it difficult to achieve and sustain the correct level of compression without real-time feedback.

It is worth noting that, in this study, the nursing team was able to deliver pressures within CT guideline ranges even during the unguided phase without pressure monitoring feedback, demonstrating their expertise. This proficiency may have reduced the observable differences between unguided and guided compression phases. However, the literature indicates that this is not always the case, as many healthcare providers find it difficult to consistently reach therapeutic compression levels.¹⁷ Such inconsistency not only undermines treatment efficacy but can also lead to poor patient adherence, as discomfort or lack of perceived benefit may discourage continued use. Thus, integrating tools that enhance understanding and support the safe and effective implementation of CT within a service can help improve patient outcomes and encourage both patients and healthcare professionals to adopt this treatment approach.¹⁸

To address these challenges, the current service evaluation assessed the use of a connected health pressure monitoring system in the treatment of VLU patients. Nurses used real-time sub-bandage pressure readings to guide compression application, resulting in a 48% increase in the proportion of times targeted pressure was achieved compared to the SoC phase, from 39% to 65.5%. Notably, the proportion of pressure readings exceeding 60mmHg increased from 7.8% during the unguided SoC phase to 19.1% in the guided SoC phase. The higher pressures applied during bandage applications could also explain the significant increase in the proportion of time that pressure readings remained within the targeted pressure range throughout the course of treatment, compared with the SoC phase of treatment (62.5% versus 26.1%, respectively). In other words, higher compression levels may be more effective at maintaining target compression pressures over time.

An exploratory analysis of wound size evolution across the service delivery phases suggested that during guided SoC, where CT was supported by real-time pressure monitoring, the average PAR per day increased from 1.31% to 2.30%, aligning with existing evidence showing an increase in VLU healing with increased compression pressure.¹⁶ It is also worth highlighting that the healing rate during the unguided SoC phase already exceeded the rates commonly reported in the literature (approximately 0.66 percentage area reduction per day²⁵). However, while this increase in healing rate was observed in most patients, variability was high and results were influenced by individual cases. Therefore, these findings should be interpreted cautiously as hypothesis-generating rather than conclusive.

Our results show that patients and their informal caregivers were able to readily adopt the pressure monitoring technology. On average, patients transmitted data 1.7 times per day, giving healthcare providers real-time insight into adherence to the prescribed CT. This feedback could be of help to customise treatment for each patient, which is vital given differences in patient profiles and comorbidities such as arterial insufficiency, heart failure, or diabetes that affect wound healing and safe compression use. Patients could have a personalised and controlled CT treatment plan based on their medical history and ongoing assessments, that may accelerate recovery.

This service evaluation shows that pressure monitoring systems have the potential to ensure the accurate application and maintenance of targeted pressure during CT, with the potential to enhance patient safety and adherence. These preliminary findings are based on a very small sample. Further research with larger, controlled trials will be required to determine whether such systems can reliably improve therapeutic outcomes and reduce the frequency of clinical visits, potentially resulting in cost savings in wound care.²⁶

Conclusion

This service evaluation shows that a connected pressure-monitoring system greatly boosts the consistency of target sub-bandage pressures during VLU CT, both at application and throughout treatment within the service. Integrating this technology into practice creates opportunities to tailor compression plans to each patient’s clinical and personal needs.

Implications for clinical practice

• Incorporating connected pressure-monitoring systems into routine VLU CT can help clinicians consistently achieve and maintain optimal sub-bandage pressures.
• Real-time pressure feedback enables more precise, patient-specific adjustments, improving healing rates and supporting personalised care plans.

Future research

• Randomised, controlled trials with sufficient sample size are needed to confirm the impact of connected pressure monitoring on long-term healing outcomes, recurrence rates, and patient quality of life.
• Investigations into cost-effectiveness, training needs, and integration with digital patient records could support broader implementation across healthcare settings.

Author contributions

Concept and design (LH, DH); data analysis and interpretation (MVM); manuscript draft (LH, MVM); critical revision of the manuscript (LH, DH); final approval of the manuscript (DH).

Conflict of interest

Co-author MVM is an employee of Feeltect Limited, representing a potential financial conflict of interest.

Funding

This study was funded by Feeltect Limited, which also supplied the pressure-monitoring devices used.

Author(s)

Liz Hawes¹, Manuel Villegas-Martinez² PhD, Daphne Hazell*¹ PhD
¹Home Wound Care UK, Bognor Regis, United Kingdom
²Feeltect Limited, Galway, Ireland

*Corresponding author email daphne@homewoundcare.co.uk

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