Ongoing research

Ongoing research

The aim of this page is to present research findings as they become available.

Thus the Diabetes Foot Research Group would like to encourage researchers who have conducted research relative to the subject, to present an abstract to be published on this page.

In order to be included in this section, Research must be published in a peer-reviewed journal, be related to the Maltese diabetes population or, if not conducted in Malta, from which the Maltese diabetic patient and practitioner can gain relevant and important information related to diabetic foot research.

Thermal Imaging for Peripheral Vascular Disease monitoring in Diabetics (TIPMID)
This first research which the Group is conducing involves Thermography which is becoming an important  investigative tool in the diabetic foot, as it detects skin temperature variations to within 0.02 deg Celcius and is totally non invasive. Areas of increased temperature are known to be predictive for the development of foot ulcers. The aim of this research is to determine whether a thermal index may provide adequate scoring range for assessing wounds by considering physiological as well as morphological changes on the skin surface.

Stage 1

  • The aim of this phase of the project is to create a normative database of temperature measurements measured within the areas of interest in healthy subjects.
  • Actual data collection of this phase has been completed on 9th August 2012. A publication in the International Journal of Vascular Medicine highlights the findings of this study.

Stage 2

  • A convenient sample of 150 participants living with type 2 diabetes are being recruited from patients attending Mater Dei Hospital. They will be divided into 3 groups of 50 participants each, living with neuropathy, ischaemia or none. Medical data and thermographic images will be recorded and compared for each group. 
  • Three full-time researchers funded by the MCST grant are currently recruiting participants and collecting data for later analysis.   
Alfred Gatt, Cynthia Formosa, Kevin Cassar, Kenneth P. Camilleri, Clifford De Raffaele, Anabelle Mizzi, Carl Azzopardi, Stephen Mizzi, Owen Falzon, Stefania Cristina and Nachiappan Chockalingam. Thermographic Patterns of the Upper and Lower Limbs: Baseline Data. International Journal of Vascular Medicine Volume 2015 (2015)

Objectives. To collect normative baseline data and identify any significant differences between hand and foot thermographic distribution patterns in a healthy adult population. Design. A single-centre, randomized, prospective study.
Methods. Thermographic data was acquired using a FLIR camera for the data acquisition of both plantar and dorsal aspects of the feet, volar aspects of the hands, and anterior aspects of the lower limbs under controlled climate conditions.
Results. There is general symmetry in skin temperature between the same regions in contralateral limbs, in terms of both magnitude and pattern. There was also minimal intersubject temperature variation with a consistent temperature pattern in toes and fingers. The thumb is the warmest digit with the temperature falling gradually between the 2nd and the 5th fingers. The big toe and the 5th toe are the warmest digits with the 2nd to the 4th toes being cooler.
Conclusion. Measurement of skin temperature of the limbs using a thermal camera is feasible and reproducible. Temperature patterns in fingers and toes are consistent with similar temperatures in contralateral limbs in healthy subjects. This study provides the basis for further research to assess the clinical usefulness of thermography in the diagnosis of vascular insufficiency.

Cynthia Formosa, Kevin Cassar, Alfred Gatt, Anabelle Mizzi, Stephen Mizzi, Kenneth P. Camileri, Carl Azzopardi, Clifford DeRaffaele, Owen Falzon, Stefania Cristina, Nachiappan Chockalingam. 2013. Hidden dangers revealed by misdiagnosed peripheral arterial disease using ABPI measurement.

Aim: The aim of this study was to compare ankle brachial indices (APBI) with pedal waveforms utilizing the continuous wave Doppler in a population with diabetes mellitus.
Methods: A prospective study design was employed to investigate the ABPI in a cohort of 49 people with type 2 diabetes mellitus. ABPI assessment was completed using a portable handheld Doppler and ankle pressures of <0.9 were taken as suggestive of peripheral arterial disease (PAD). Arterial spectral waveforms in each foot were also recorded and compared to the ABPI readings.
Results: Inconsistencies were identified between ABPIs and waveform interpretations in the study population. Approximately 35% of subjects had inconsistencies between their ABPI result and waveform interpretation in their right or left foot.
Conclusions: Both ABPIs and Doppler waveforms should be used in the assessment of people with diabetes in order to screen for PAD. This would ensure an accurate assessment of PAD and would allow initiation of appropriate secondary risk factor control measures.
Formosa C, Mandy A, Lucas K. 2011. Identifying changes in diabetes care. Practical Diabetes International. 28 (1): 31-34

Malta is a small Mediterranean island with particularly distinct population and culture. It also has one of the highest rates of type 2 diabetes in the world. As a result it provides a unique microcosm of problems in diabetes care common across Europe. This study explores the effects of culture, religion and government organisation on the management of patients with diabetes.

The cultures of patients, health care professionals and the Maltese government were examined in terms of their influence on the potential to deliver culturally relevant competent care.

The results of this research indicate that national culture and local practices may have a detrimental influence on the management of diabetes in Malta. The findings highlight the need for change if effective diabetes care is to be offered to the Maltese population. These changes are related to a highly complex, poorly understood health care system, and to the way in which it is structured and the way health care processes are managed in this highly specific national and ethnic culture. Copyright © 2011 John Wiley & Sons.

Formosa C, Vella L. 2011. Influence of diabetes related knowledge on foot ulceration. The Diabetic Foot Journal. 14(2): 21-26

To investigate the relationship between diabetes-related knowledge and foot ulceration among people with type 2 diabetes, the authors assessed diabetes knowledge in groups with and without foot ulceration. There was no significant difference in diabetes-related knowledge between the two groups, although the mean level of knowledge in the group with foot ulceration was greater. The authors’ question current approaches to diabetes education and suggest that a new approach to diabetes education programmes is needed.

Formosa C, Lucas K, Mandy A, Keller C. 2008. Influence of national culture on diabetes education in Malta: A case example. Diabetes and Primary Care. 10(2):109-116

Diabetes is a condition of particular importance to the Maltese population. Currently, 10% of the Maltese population has diabetes, compared with 2-5% of the population in the majority of Malta's neighbouring European nations (Rocchiccioli et al, 2005). The high prevalence of diabetes results in nearly one out of every four deaths of Maltese people occurring before the age of 65 years (Cachia, 2003). In this article we explore the possible contributions of the unique Maltese culture to the epidemiology, we hope that some lessons can be taken when attempting educational interventions in people of differing backgrounds.

Formosa C, McInnes A, Mandy A. 2012. Rethinking diabetes education. Journal of Diabetes Nursing 16(6): 234-238

One of the core components of diabetes care is the promotion of diabetes education to improve self-management, which would reduce the financial and personal burden that diabetes imposes. However, as education and knowledge alone do not always translate into improved metabolic outcomes, a fuller understanding of the factors that contribute to suboptimal self-management is important if improved diabetes outcomes are to be achieved. In this article the authors question the current approaches to diabetes education, and highlight how education might be broadened to produce more effective outcomes. The authors suggest a move away from traditional, didactic, diabetes-related education, which has failed in a number of settings, towards innovative approaches that are person-centred to improve metabolic outcomes and quality of life for individuals with diabetes.

Formosa C, Savona-Ventura C, Mandy A. 2012. Cultural contributors to the development of diabetes mellitus in Malta. International Journal Diabetes and Metabolism 20: 25-29

Diabetes mellitus is a condition of particular importance to the Maltese population. Currently 16.7% of the Maltese population is living with diabetes or impaired glucose tolerance. A cultural and historical evaluation of this area-restricted archipelago population has suggested that the associated high prevalence of diabetes may be the result of the Baker-Pederson hypothesis cycles following an original adaptation to a thrifty near starvation diet.

Formosa C, Gatt A, Chockalingam N. 2012. Diabetic foot complications in Malta: Prevalence of risk factors. The Foot.

Aims: The main objective of this research was to identify the prevalence of diabetes-related lower-extremity complications in a cohort of Maltese patients living with type 2 diabetes.
Methods: A retrospective study was conducted on a cohort of 243 patients living with type 2 diabetes mellitus in two Maltese Health Centre catchment areas. A convenience sampling was adopted to recruit subjects from a local pilot diabetes foot screening program. The clinical assessments used during this screening program were based on validated and previously published tools such as: neuropathy disability score, vibration perception threshold, Semmes–Weinstein monofilaments, vascular status and foot deformities were evaluated.
Results: The results from this study demonstrate that risk factors for foot deterioration and ulceration are common in Maltese population living with type 2 diabetes. Whilst, metabolic outcomes such as hypertension and dyslipidaemia were present in most subjects, peripheral vascular disease, peripheral sensory neuropathy and foot deformities were also common. Twenty-six per cent of the sample had to be referred for further vascular assessment following this screening program due to their critical vascular status.
Conclusions/interpretation: A significant proportion of Maltese participants living with type 2 diabetes presented with vascular insufficiency, abnormal neural function and deformities in the feet. Metabolic outcomes such as high blood pressure and high levels of cholesterol were also highly prevalent. Strengthening of existing screening structures is imperative in order to reduce the burden of this disease in Malta.

Formosa C, Gatt A, Chockalingam N. 2012. The importance of diabetes foot care education in a primary care setting. Journal of Diabetes Nursing. Vol 16 No 10. 410-414

It has been reported that foot examinations by health care professionals, together with appropriate educational initiatives, play a vital role in decreasing diabetic foot complications. A fuller understanding of the factors that contribute to suboptimal foot care, leading to costly diabetic complications, is important for improved outcomes. In this article, the authors highlight the importance of diabetes foot care education in primary care settings amongst people living with type 2 diabetes.

Formosa C, Gatt A, Chockalingam N. 2012. Screening for peripheral vascular disease in patients with type 2 diabetes in Malta in a primary care setting. Quality in Primary Care 20:409-14

Background: Peripheral vascular disease (PVD) is strongly associated with type 2 diabetes. PVD assessment and diagnosis are often neglected in primary care office visits, and ankle/brachial pressure index (ABPI) examinations are seldom performed for PVD detection. The purpose of this study was to evaluate the occurrence of PVD in a primary care setting using ABPI in patients with type 2 diabetes in Malta. Method A retrospective study was conducted on a cohort of 243 patients with type 2 diabetes to address various issues. As part of this large study, data from ABPI measurements collected using a portable hand-held Doppler with ankle pressures of <0.8 suggestive of PVD were extracted.
Results: Twenty-six per cent of the sample had to be referred for further vascular assessment following this screening programme due to their critical vascular status. Furthermore, at the time of examination, approximately 7% of the patients had an ABPI of less than 0.8 in both left and right extremities.
Conclusion: A significant proportion of Maltese patients with type 2 diabetes who visit primary care present with vascular insufficiency. The use of ABPI should be considered as an added measurement in order to facilitate early detection and treatment and reduce the burden of PVD in this high-risk population.

Formosa C, Gatt A, Chockalingam N. 2013. The importance of clinical biomechanical assessment of foot deformity and joint mobility in people living with type-2 diabetes within a primary care setting. Primary Care Diabetes. 2013 Apr;7(1):45-50. doi: 10.1016/j.pcd.2012.12.003

Aims: The aim of the study was to assess foot morphology and document foot deformities and joint mobility in a cohort of subjects living with type-2 diabetes mellitus in Malta in a Primary Care setting.
Methods: A retrospective observational study was conducted on 243 subjects who participated in a local pilot diabetes foot screening project. Assessments included hammer/claw toes, hallux valgus, hallux limitus, prominent metatarsal heads, bony prominences, Charcot deformity, plantar callus, foot type and ankle and hallux mobility. The clinical assessments used during this screening program were based on validated and previously published tools.
Results: Upon clinical examination 38% of the sample was found to have developed some form of corns or callosities in their feet. Hallux valgus deformity was present in 49.4% of the sample, whilst 39% of the sample had hammer toes. Prominent metatarsal heads (24%), other bony prominences (44%) and limited joint mobility were also reported. Furthermore, 56% of the sample presented with unsuitable footwear and upon clinical biomechanical examination a further 28% of the sample required prescription orthosis.
Conclusions/interpretation: A significant proportion of participants living with type-2 diabetes presented with foot deformities which are known to be predictive of foot ulceration in this high risk population. This research conducted in a primary care setting highlights the importance of increased vigilance coupled with strengthening of existing screening structures and introducing clinical guidelines with regards to biomechanical assessment of the feet in a primary care setting in order to reduce the incidence of diabetes foot complications.

Bartolo P, Mizzi S, Formosa C. 2013. An evaluation of foot care behaviours in individuals with type 2 diabetes living in Malta. Journal of Diabetes Nursing. 17: 73-78


Improving how individuals with type 2 diabetes look after their feet is reported to be one of the most effective strategies in minimising diabetic foot complications. This study evaluated foot care behaviour in people with type 2 diabetes living in Malta. Participants were grouped according to age (45–64 years [n=30] and ≥65 years [n=30]); the Nottingham Assessment of Functional Footcare (NAFF; Lincoln et al, 2007) was used to determine foot care behaviours in both groups. There was no significant difference in NAFF scores between the two groups (P=0.635); the mean NAFF score for the group aged 45–64 years was 55.43 and for the group aged ≥65 years was 54.73. Since the possible maximum NAFF score is 87, both groups showed suboptimal foot care behaviour in terms of footwear, hosiery and wound management. Healthcare professionals play an important part in helping individuals with diabetes improve their foot care behaviour and lifestyle to minimise foot complications.

Ellul C, Mizzi A, Formosa C. (2014) Early Identification of Asymptomatic Peripheral Arterial Disease in Smokers. The Journal for Nurse Practitioners Volume 10 Issue 8.

This study investigated whether daily tobacco smoking affects peripheral artery insufficiency in a cohort of middle-aged individuals. A matched nonexperimental study was used. Twenty smokers and 20 nonsmokers not suffering from any cardiovascular disease were recruited. The Huntleigh Dopplex Assist was used to measure the ankle brachial pressure index (ABPI) and quantitatively analyze the Doppler arterial waveforms. There was no significant difference in mean ABPI scores between smokers and nonsmokers; however, significant difference was noted in the Doppler waveforms on all arteries assessed between groups. Doppler waveforms should be used to assess smokers to screen for peripheral arterial disease.

Caruana L., Formosa C., Cassar K (2015). Prediction of Wound Healing after Minor Amputations of the Diabetic Foot.  Journal of Diabetes and Its Complications 29; 834-837.

Aim: To identify any significant differences in physiological test results between healing and non healing amputation sites. METHODS: A single center prospective non-experimental study design was conducted on fifty subjects living with type 2 diabetes and requiring a forefoot or toe amputation. Subjects underwent non-invasive physiological testing preoperatively. These included assessment of pedal pulses, preoperative arterial spectral waveforms at the ankle, absolute toe pressures, toe-brachial pressure index and ankle-brachial pressure index. After 6 weeks, patients were examined to assess whether the amputation site was completely healed, was healing, had developed complications, or did not heal.
Results: There was no significant difference in ABPI between the healed/healing and the non-healing groups. Mean TBI (p=0.031) and toe pressure readings (p=0.014) were significantly higher in the healed/healing group compared to the non healing group. A significant difference was also found in ankle spectral waveforms between the two groups (p=0.028).
Conclusions: TBIs, toe pressures and spectral waveforms at the ankle are better predictors of likelihood of healing and non-healing after minor amputation than ABPIs. ABPI alone is a poor indicator of the likelihood of healing of minor amputations and should not be relied on to determine need for revascularization procedures before minor amputation.

Vassallo IM, Formosa C (2015). Comparing Calcium Alginate Dressings to Vacuum-assisted Closure: A Clinical Trial.  Wounds 27 (7).

Introduction: Several treatment modalities and protocols for arterial wound ulcers are available; however, little consensus exists on which treatment modality provides the best results. The present study sought to compare and evaluate the clinical efficacy of vacuum-assisted closure wound therapy to calcium alginate dressings in the treatment of neuroischemic diabetic foot ulceration.
Material and methods: A single-center quasi-experimental matched subject clinical trial was conducted on 30 subjects living with type 2 diabetes and presenting with a newly diagnosed neuroischemic foot ulceration. Subjects were divided into 2 groups. Group A (n = 15) underwent negative pressure wound therapy and Group B (n =15) underwent treatment using calcium alginate dressings. Ulcer area and depth were measured during the trial.
Results: Both negative pressure therapy and calcium alginate dressings were effective in reducing the surface area and depth of ulcers (P = 0.0001). However, negative pressure was 3.2 times more effective in reducing surface area and 3.78 times more effective in reducing depth of ulcers when compared to calcium alginate (P = 0.0001).
Conclusion: Vacuum-assisted closure should be considered as the treatment of choice for neuroischemic ulceration owing to its advantages in reducing surface area and depth when compared to calcium alginate