A longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes

doi:10.1016/j.jdiacomp.2007.06.006

Journal of Diabetes and its Complications

Volume 22, Issue 6, November–December 2008, Pages 400-407

https://doi.org/10.1016/j.jdiacomp.2007.06.006 Get rights and content

Abstract

Objective

The objectives of this study were to assess ulcer healing in patients with diabetic foot ulcers during a 1-year follow-up, to compare health-related quality of life (HRQL) between those with healing ulcers and those with ulceration, and to assess whether changes in healing affect patients' HRQL.

Methods

Data were collected at baseline, after 6 months (T₂), and after 12 months (T₃). Adult patients (n=127) with type 1 or type 2 diabetes and foot ulcers were recruited from outpatient clinics. Self-assessed HRQL was measured using the SF-36 Health Survey at all measurement points. Sociodemographic and clinical data were obtained at baseline, and data on healing, ulceration, and amputation were obtained at T₂ and T₃.

Results

Of 127 patients included at baseline, 35% had persistent ulcer, 37% had healed ulcer, 6% had undergone amputation, and 7% had died at T₃. In addition, 9% had undergone amputation at T₂. Significant differences were observed between patients with healed ulcers and patients with persistent ulcers on general health at baseline; on physical functioning, general health, and social functioning at T₂; and on five of eight subscales in the SF-36 (e.g., physical functioning, role limitation—physical, general health, social functioning, and mental health) and on the physical summary score at T₃. Furthermore, HRQL improved significantly in social functioning and mental health in parallel with healing of ulcers, and deteriorated in the social functioning subscale in parallel with nonhealing of ulcers.

Conclusions

Only 37% of ulcers healed during the 1-year follow-up. Poor HRQL during follow-up was associated with poor ulcer prognosis.

Introduction

Diabetic foot ulcers (DFUs) often fail to heal despite appropriate treatment and often become chronic (Jeffcoate, Price, & Harding, 2004). The shortest healing time is observed in neuropathic ulcers, compared with ulcers of ischemic or mixed etiology (Pound, Chipchase, Treece, Game, & Jeffcoate, 2005). Obviously, DFUs are highly heterogeneous, and comparing different ulcer populations is difficult. In one study, 31% of neuropathic ulcers had healed after 20 weeks of appropriate treatment (Margolis, Kantor, & Berlin, 1999). In another study, after 6 months of treatment, 48% of ulcers had healed, 40% of ulcers were unhealed, 3% of patients had lost a lower limb, and 6% had died (Jeffcoate & Harding, 2003). Boulton, Meneses, and Ennis (1999), using a multidisciplinary team and standard wound care approach, found that the majority of wounds (88%) healed.

Foot ulcers that last for >4 weeks are associated with the worst outcome and an increased risk of amputation (American Diabetes Association, nd, Jeffcoate et al., 2004). Patients with previous ulcers have a high risk for new ulcerations and further amputations, and have an increased mortality rate (Apelqvist, 1998). According to the American Diabetes Association's (1999) Consensus Development Conference on Diabetic Foot Wound Care, the incidence of ulcers at the same site or at different sites in a foot with prior ulceration is >50% over 2–5 years.

A number of studies have demonstrated that health-related quality of life (HRQL) is negatively affected by DFUs, and some of the studies have shown that patients with current foot ulcers rated their HRQL lower than did patients with healed ulcers (Goodridge et al., 2006, Nabuurs-Franssen et al., 2005, Tennvall & Apelqvist, 2000, Valensi et al., 2005). Furthermore, HRQL was lower for patients with a current ulcer compared with those with a minor amputation, but HRQL was still lower in those with a major amputation (Tennvall & Apelqvist, 2000).

Using the SF-36 Health Survey, a frequently used HRQL questionnaire (Ware, Kosinski, & Gandek, 2000), Meijer et al. (2001) found that the presence of DFUs had a great impact on physical health, and Ahroni and Boyko (2000) found that changes in foot ulcer status were significantly associated with changes in the SF-36 subscales of physical functioning and role limitation—physical. Only a few studies have prospectively investigated patients with DFU (Abetz et al., 2002, Nabuurs-Franssen et al., 2005). One study followed patients over a period of 3 months and noted higher HRQL scores in physical and social functionings in patients with healed ulcers compared with patients with unhealed ulcers (Nabuurs-Franssen et al., 2005).

The aims of the present study were as follows:

1.
To assess wound healing during a 1-year follow-up in patients with DFUs;
2.
To compare HRQL in these patients at baseline, and after 6 and 12 months of follow-up; and
3.
To assess whether wound healing is related to changes observed in patients' HRQL.

Section snippets

Methods

The study design was prospective and observational. A group of patients who were referred for DFUs and who received routine treatment for ulcers at six outpatient clinics in Oslo, Norway, was studied. Data were collected at baseline (T₁), and at 6 months (T₂) and 12 months (T₃) after inclusion. The 6-month test point was chosen in order to compare clinical data with the data of previous studies (Jeffcoate & Harding, 2003). The 12-month follow-up was chosen to assess long-term development and

Sociodemographic and clinical characteristics of patients

The sociodemographic and clinical characteristics of the patients are given in Table 1. The mean age was 61 years (S.D.=13.8), and the majority of the patients were elderly, were obese men, were living alone, had low education, and were not on regular work at the time of inclusion (Ribu, Hanestad, Moum, Birkeland, & Rustoen, 2006). Of all the patients, 29% had type 1 diabetes, and the mean duration of diabetes was 19 years (S.D.=12.9). The patients' mean HbA1c level was 8.6 (S.D.=1.9); the mean

Conclusions

As far as we know, this is the first study to have examined HRQL in patients with DFUs over a period of 12 months and to have assessed their HRQL in relation to wound healing. Only 37% of the patients were ulcer-free 12 months after inclusion in the study, indicating the seriousness of DFUs in these patients. As previous studies have shown that patients with DFUs have a mortality risk that is more than double that of patients without DFUs (Boyko, Ahroni, Smith, & Davignon, 1996), our findings

Acknowledgment

This study was supported by Oslo University College (Oslo, Norway). The authors thank the patients, the nurses in diabetes clinics, and the hospitals for making this study possible. We wish to thank Reidun Mosand and Sissel Martinsen (Aker University Hospital); Anita Skafjeld and Kari Ihlen (Ulleval University Hospital); Elsa Orvik and Beate Sogaard (Asker and Baerum Hospital); Elisa Horntvedt Ellefsen (Diakonhjemmet Hospital); Anne-Kristin Bakkeli and Elisabeth Huseby (Lovisenberg Diakonale

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Diabetes-related foot ulcers (DFU) are a leading cause of infection, hospitalisation and amputation. However, to our knowledge no studies have compared the health-related quality of life (HRQoL) of people with DFU that were infected, hospitalised or amputated. This study aimed to investigate and compare the HRQoL of different groups of people with healed, non-infected, infected, hospitalised, or amputated DFU.
This was a multi-centre cross-sectional study measuring the HRQoL of patients, attending one of 18 Diabetic Foot Services across Queensland, Australia, with one of five DFU health states: healed, non-infected, infected, hospitalised, amputated. HRQoL was measured using the EQ-5D-5L to estimate age-sex adjusted utility values.
Of 376 included patients (mean age 63 (12) years, 75% male), age-sex adjusted HRQoL utility estimates (95% CIs) were: healed DFU 0.57 (0.51–0.64), non-infected DFU 0.55 (0.49–0.62), infected DFU 0.45 (0.36–0.55), hospitalised DFU 0.53 (0.42–0.64), and amputated DFU 0.55 (0.46–0.63).
People in any DFU health state have considerably reduced HRQoL, with greatest reductions in those with infected DFU. These findings provide valuable HRQoL estimates and comparisons for several different important DFU health states, adding to our understanding of the impact of DFU on HRQoL and facilitating future economic evaluations.
Patient-Reported Outcome Measures of Quality of Life in People Affected by Diabetic Foot: A Psychometric Systematic Review
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This psychometric systematic review aimed to identify the most suitable patient-reported outcome measures (PROMs) of quality of life (QoL) in people affected by diabetic foot.
We performed a literature search in MEDLINE (PubMed), CINAHL (EBSCOhost), and PsycINFO (EBSCOhost) databases from inception to February 1, 2022. We also searched gray literature databases. Eligible studies were full-text reports developing a QoL condition-specific PROM or assessing one or more of its measurement properties in people affected by diabetic foot. We assessed the methodological quality of included studies independently using the “Consensus-Based Standards for the Selection of Health Measurement Instruments Risk of Bias” checklist. The measurement properties were evaluated using specific criteria. We graded the quality of the evidence using a “Grading of Recommendations Assessment, Development and Evaluation” approach modified by Consensus-Based Standards for the Selection of Health Measurement Instruments.
Forty-three reports (46 studies) providing information on the measurement properties of 10 different PROMs were included. We did not identify any instruments that could be recommended for use. We identified 2 PROMs that were not recommended for use and 8 that were potentially recommended but would require further investigation. Of these 8 PROMs, 4 had better evidence for content validity.
Available PROMs to measure QoL in people affected by diabetic foot have limited evidence for their measurement properties. There is no fully suitable PROM. Pending further evidence, 4 PROMs could potentially be recommended for use.
Amputation and infection are the greatest fears in patients with diabetes foot complications
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To determine the degree patients with diabetic foot ulcers, Charcot neuroarthropathy and neuropathic fractures and dislocations fear complications (death, dialysis, heart attack, stroke, blindness, diabetic foot infection, minor and major lower extremity amputation [LEA]) that can occur and to assess if there is a difference between fears of patients with diabetic foot ulcers, Charcot neuroarthropathy and neuropathic fractures and dislocations and diabetic patients without these complications.
478 patients completed an eight question Likert scale survey. The study group was defined as non-infected foot ulcers, neuropathic fractures and Charcot neuroarthropathy.
Of the 478 patients, 121 (25.3 %) had diabetic foot ulcers, Charcot neuroarthropathy or neuropathic fractures and dislocations and 357 (74.7 %) did not. The study group had significantly higher odds of reporting extreme fear of foot infection (OR 2.8, 95 % CI 1.8–4.5), major LEA (OR 2.8, 95 % CI 1.8–4.4), minor LEA (OR 2.3, 95 % CI 1.5–3.5), blindness (OR 2.0, 95 % CI 1.3–3.2), dialysis (OR 2.0, 95 % CI 1.1–3.3), and death (OR 2.4, 95 % CI 1.4–4.2). In the study group highest rated fear measures were foot infection (3.71, SD 1.23), minor amputation (3.67, SD 1.45) and major amputation (3.63, SD 1.52). There were no significant differences in the mean fear of infection, minor amputation or major amputation.
Patients with diabetic foot ulcers, Charcot neuroarthropathy or neuropathic fractures and dislocations reported higher fear ratings of diabetes-related complications compared to those without these complications.
Physical Activity Participation in People With an Active Diabetic Foot Ulceration: A Scoping Review
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Being physically active on a regular basis has a favourable impact on diabetes-related complications. With the exception of evidence advising individuals with an active diabetic foot ulceration (DFU) to avoid weight-bearing activity, no physical activity (PA) recommendations are currently provided for this population.
The aim of this scoping review was to examine and map the existing research evidence of PA participation for individuals with an active DFU.
A scoping review using the Arksey and O’Malley framework was conducted in electronic databases and grey literature from inception to June 2020 to identify publications that investigated individuals with type 1 or type 2 diabetes and an active DFU at enrolment in relation to a PA intervention. Reported outcomes had to inform on effects of PA on any health or wound parameters.
Nineteen articles from 17 distinct studies met inclusion criteria. Fourteen of the included studies were published in the last 10 years. Types of exercises and materials used, duration of studies, offloading considerations and provision of wound care varied greatly between studies. Included studies are heterogenous in methodological designs and aims, and reporting was often lacking important components of wound care and PA interventions. A discussion based on descriptive statistics and narrative analysis is provided.
It is not possible from this scoping review to determine what would be the ideal components of a PA program for this specific population. Conclusions are limited by the quality and design of the included studies. No articles evaluated quality of life, mortality or cardiorespiratory capacity, nor were adverse effects routinely reported.
La pratique régulière de l’activité physique a des répercussions favorables sur les complications liées au diabète. À l’exception des données probantes qui suggèrent que les individus qui ont une ulcération active du pied diabétique (UPD) évitent les activités avec mise en charge, aucune recommandation en matière d’activité physique (AP) n’est actuellement fournie à cette population.
L’objectif de cette étude de portée était d’examiner et de cartographier les données existantes issues de la recherche sur la participation à l’AP des individus qui ont une UPD active.
Nous avons réalisé une étude de portée à l’aide du cadre d’Arksey et O’Malley dans les bases de données électroniques et la littérature grise de leur création à juin 2020. Les publications qui portaient sur les individus atteints du diabète de type 1 et de type 2 et d’un UPD actif à l’inscription en lien avec une intervention en matière d’AP. Les résultats signalés devaient fournir des informations sur les effets de l’AP sur tous les paramètres de santé et de la plaie.
Dix-neuf articles issus de 17 études distinctes remplissaient les critères d’inclusion. Quatorze études ont été publiées au cours de la dernière décennie. Les types d’exercices et d’équipements utilisés, la durée des études, les considérations de mise en décharge, la prestation de soins liés aux plaies variaient considérablement entre les études. Les études incluses sont hétérogènes sur le plan de la conception méthodologique et des objectifs, mais des éléments importants sur les soins des plaies et les interventions en matière d’AP faisaient souvent défaut. Nous présentons une discussion basée sur les statistiques descriptives et l’analyse narrative.
Cette étude de portée ne permet pas de déterminer les éléments idéaux d’un programme d’AP destiné à cette population. Les conclusions sont limitées par la qualité et la conception des études incluses. Aucun article ne portait sur l’évaluation de la qualité de vie, la mortalité ou la capacité cardiorespiratoire, ni aucun effet néfaste n’était systématiquement signalé.
A Longitudinal Study on the Association Between Diabetic Foot Disease and Health-Related Quality of Life in Adults With Type 2 Diabetes
2020, Canadian Journal of Diabetes
The aim of this study was to assess the association between diabetic foot disease and health-related quality of life (HRQOL) during a 2-year follow up among people with type 2 diabetes in Alberta.
A type 2 diabetes cohort was established (2011‒2013); those with self-reported diabetic foot disease were identified. HRQOL was assessed at baseline and 1 and 2 years. Scores from the 12-item Short Form Physical Component Summary (PCS) and Mental Component Summary (MCS) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument were collected. The association between diabetic foot disease and changes in HRQOL was assessed using the general linear mixed model after adjustment for sociodemographics, previous health-care use, Elixhauser comorbidities index, baseline health status and diabetes-specific behaviours.
Among the cohort (n=969), average age was 64.3 (standard deviation, 10.0) years and 55% were male. Overall, 265 (27.4%) participants reported having diabetic foot disease. Those with diabetic foot disease reported lower HRQOL in comparison to those without diabetic foot disease at baseline: PCS, 8.44 (95% confidence interval [CI], 7.06 to 9.82); MCS, 4.33 (95% CI, 2.99 to 5.67) and EQ-5D-5L index score, 0.12 (95% CI, 0.09 to 0.14). After adjustment, no differences were observed in the score changes at year 2 (PCS, 0.16 [95% CI, -0.88 to 1.21]; MCS, 0.36 [95% CI, -0.77 to 1.50]; EQ-5D-5L index score, 0.004 [95% CI, -0.01 to 0.02]).
Although participants with diabetic foot disease reported lower HRQOL at baseline, they had similar changes compared to those without diabetic foot disease during the 2-year follow up. Efforts to maintain general health and early intervention to prevent diabetic foot disease may help to avoid initial deterioration of physical health and HRQOL.
Le but de cette étude était d'évaluer l'association entre une condition de pied diabétique et la qualité de vie liée à la santé (QVLS) au cours d'un suivi de deux ans chez les personnes atteintes de diabète de type 2 en Alberta.
Méthodes: Une cohorte de diabétiques de type 2 a été établie (2011-2013); ceux qui avaient déclaré eux-mêmes un pied diabétique ont été identifiés. La QVLS a été évaluée au départ et après une période de 1 et 2 ans. Les notes obtenues aux 12 points du questionnaire abrégé du Bilan de Santé Physique (BSP) et du Bilan de Santé Mentale (BSM) en 12 points, ainsi que celles de l'instrument descriptif à 5 dimensions de 5 niveaux EuroQol (EQ-5D-5L). L'association entre une condition de pied diabétique et les changements de la QVLS a été évaluée à l'aide du modèle linéaire mixte généralisé après ajustement pour les facteurs sociodémographiques, de l'utilisation antérieure de soins de santé, de l'indice de comorbidités Elixhauser, de l'état de santé initial et des comportements propres au diabète.
Résultats: Dans la cohorte (n=969), l'âge moyen était de 64.3 ans (écart-type, 10.0) et 55% étaient des hommes. Dans l'ensemble, 265 participants (27.4%) ont déclaré souffrir d'un pied diabétique. Les personnes atteintes d'un pied diabétique ont déclaré une QVLS inférieure à celle des personnes sans pied diabétique au début de l'étude: BSP, 8.44 (intervalle de confiance à 95%[IC], 7.06 à 9.82); BSM, 4.33 (IC à 95%, 2.99 à 5.67); et indice EQ-5D-5L, 0,12 (IC à 95%, 0.09 à 0.14). Après ajustement, aucune différence n'a été observée dans les changements de score après 2 ans (BSP, 016[IC à 95%, -0.88 à 1.21]; BSM, 0.36 [IC à 95%, -0.77 à 1.50]; indice EQ-5D-5L, 0.004[IC à 95%, -0.01 à 0.02]).
Bien que les participants atteints d'un pied diabétique aient déclaré initialement une QVLS inférieure, ils ont connu des changements semblables à ceux des participants sans pied diabétique au cours du suivi de deux ans. Les efforts visant à maintenir l'état de santé général et une intervention précoce pour prévenir le pied diabétique peuvent aider à éviter la détérioration initiale de la santé physique et de la QVLS.
Impact of patient-education on health related quality of life of diabetic foot ulcer patients: A randomized study
2019, Clinical Epidemiology and Global Health
Citation Excerpt :
DFU is a major burden for the individuals from the patient's immediate surroundings because it is the duty of caregivers to regularly support in wound care and cope with physical disabilities and emotional distress. Some studies show that patients with unhealed wounds were frustrated and anxious about healing, found it difficult to cope with daily living activities, inappropriate foot wear, and complained of a limited social life.14,15 Studies have shown that foot-education improves knowledge-level and satisfaction among high risk DFU patients.16
Diabetic foot is the most serious and disabling long term complication of diabetes, adversely affecting the health related quality of life (HRQoL).
To evaluates the impact of patient-education (PE) on HRQoL of diabetic foot ulcer (DFU) patients.
This randomized controlled study on the effect of PE on improvement of HRQoL, conducted in Kasturba Hospital, Manipal, India consisted of 135 DFU patients with 65 subjects in the control group (CG) and 70 subjects in the intervention group (IG). RAND-36 questionnaire was employed for evaluating HRQoL scores of DFU patients in both groups at baseline and after six months of PE.
Subjects in the both IG and CG reported poor HRQoL scores, on all the eight subscales at baseline. After six months of PE, HRQoL improved substantially in IG with respect to CG and IG at baseline (p < 0.05). Likewise, in both CG and IG, the physical component summary scale (PCS) scores (24.1 ± 6.6 vs 25.6 ± 7.3) and the mental component summary scale (MCS) scores (27.3 ± 5.4 vs 28.8 ± 7.1) were similar and poor before PE. However, six months post PE, in IG, the Both PCS and MCS scores increased dramatically from 25.6 ± 7.3 to 42.9 ± 9.7 and 28.8 ± 7.1 to 48.8 ± 8.4 (p < 0.05) respectively.
The remarkable improvement in the HRQoL in IG at six months follow-up suggests that PE significantly improves HRQoL in DFU patients. Overworked physicians and paucity of trained doctors in resource-poor settings obligate task-sharing with non-physician healthcare providers.

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Original articleA longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes

Abstract

Objective

Methods

Results

Conclusions

Introduction

Section snippets

Methods

Sociodemographic and clinical characteristics of patients

Conclusions

Acknowledgment

Journal of Diabetes and its Complications

Clinics in Podiatric Medicine and Surgery

Mayo Clinic Proceedings

Lancet

Journal of Clinical Epidemiology

Journal of Pain

Mayo Clinic Proceedings

Diabetes and Metabolism

The Diabetic Foot Ulcer Scale (DFS): A quality of life instrument for use in clinical trials

Practical Diabetes International

Diabetic foot ulcers: A framework for prevention and care

Wound Repair Regen

Increased mortality associated with diabetic foot ulcer

Diabetic Medicine

The Norwegian College of General Practitioner's program for general practice

The measurement of atherosclerotic peripheral arterial disease in epidemiological surveys

International Journal of Epidemiology

Quality of life of adults with unhealed and healed diabetic foot ulcers

Foot and Ankle International

Morbidity and health-related quality of life among ambulant elderly citizens

Aging Clinical Experimental Research

Dimensions of quality of life in people with non-insulin-dependent diabetes

Quality of Life Research

Self-rated health and mortality: A review of twenty-seven community studies

Journal of Health and Social Behavior

Original article
A longitudinal study of patients with diabetes and foot ulcers and their health-related quality of life: wound healing and quality-of-life changes