Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer

• ClinicalTrials.gov Identifier: NCT04698720
• Recruitment Status: Recruiting
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Sponsor: University of Minho
• Collaborator: Foundation for Science and Technology (Portugal)
• Information provided by (Responsible Party): Maria da Graça Pereira, University of Minho

Study Description

Brief Summary:

Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Research suggests that psychological factors may play an important role in DFU healing. Relaxation and hypnosis seem to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular chronic wounds such as DFU.

This study will evaluate the efficacy of relaxation and hypnosis, both with guided imagery, in DFU healing, physiological (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) of wound healing prognosis and QoL, in patients with diabetic foot and a chronic ulcer. This study is a Randomized Controlled Study of a Psychological Intervention that aims to evaluate the efficiency of a muscle relaxation intervention with guided imagery (experimental group - EG1) compare to a hypnosis intervention with guided imagery (experimental group - EG2) and a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG).

This study will also examine, qualitatively, the perspectives of patients with DFU on the hypnosis intervention, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapy. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the four conditions - EG1, EG2, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the hypnosis sessions and to the informal caregivers who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Diabetic Foot Ulcer	Behavioral: Muscle Relaxation with Guided Imagery; Behavioral: Hypnosis with Guided Imagery; Behavioral: Neutral Guided Imagery	Not Applicable

Detailed Description:

General Aim:

This RCT aims to assess the effectiveness of a muscle relaxation intervention with guided imagery (EG1) compared to hypnosis with guided imagery intervention (EG2) and a neutral guided imagery placebo (ACG) and a group that does not receive any psychological intervention (PCG), in DFU healing, physiological of wound healing prognosis and Quality of life, in patients with diabetic foot and a chronic ulcer.

This study will also examine, qualitatively, the perspectives of patients with DFU regarding the interventions (EG1 and EG2) in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapy.

Specific aim:

1. To compare the impact of both experimental groups (EG1 and EG2) on psychological stress markers, in DFU healing, physiological indicators (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) healing prognosis and QoL compared to the (PCG); between pre and post intervention in the EG1 and EG2, controlling for clinical and sociodemographic variables, adherence to DFU care and patients' literacy.

   Qualitative study nested in RCT specific aims:

2. To assess psychological markers (anxiety, depression and stress), physiological indicators of healing prognosis (markers inflammatory diseases, biochemical parameters, angiogenic markers, micro RNAs, and T lymphocyte populations), adherence to UPD care, degree of UPD healing, QOL and family support / care informal, over time in patients with chronic DFU undergoing EG1 versus patients undergoing EG2 versus patients undergoing PCG and versus patients undergoing ACG.
3. To assess the evolution of psychological stress markers, physiological indicators of healing prognosis, adherence to UPD care, QOL and family support / informal care in patients with chronic DFU undergoing EG1, comparing a case with a positive evolution (healing of the DFU) with a case with a negative evolution ( DFU healing).
4. To assess the evolution of psychological stress markers, physiological indicators of healing prognosis, adherence to UPD care, QOL and family support / informal care in patients with chronic DFU undergoing EG2, comparing a case with a positive evolution (healing of the DFU) with a case with a negative evolution ( DFU healing).

Sample size calculation:

The sample size calculation considering the average effect size of 0.5, a statistical power of 80% and a significance level of 5%, and the number of variables in structural equation models, revealed that 12 participants were needed in each of the groups (12X4), totalizing 48 participants.

Procedure:

The doctor or nurse, in the medical appointment, identifies patients that meet the medical inclusion criteria. Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent. If patients agree to participate, they will sign the consent form. Nurses will then complete RESVECH 2.0 at the end of the appointment and doctors will complete the clinical questionnaire. Afterwards, the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format.

After answering the questionnaires, the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress, anxiety and depression, and if the patient is eligible, at the end of that week, the participant will be randomized into one of four possible groups.

In the next diabetic foot appointment, the respective participant will be informed about the group to which he or she has been allocated and whether will benefit, if appropriate, from four sessions of relaxation (EG1), from four sessions of hypnosis (EG2) or neutral guided imagery (ACG) or a group that does not receive any psychological intervention (PCG). If the participant is available, the first session will take place on the same day. The following sessions will be scheduled according to the medical diabetic foot consultations. In each session, two assessments of blood pressure and heart rate will be performed, before starting the session and at the end of the session. At the end of the fourth session, the T1 assessment will be performed, with a new administration of the questionnaires. Six months after T0, the T2 (follow-up) evaluation will take place, with the last administration of the questionnaires. At T0, T1 and T2 a blood and DFU swab sample will be collected for the evaluation of the physiology variables. Plasma and peripheral blood mononuclear cells (PBMC)s will be separated from the blood samples and frozen at -80ºC for analysis by the biochemical team member. Blood lymphocyte populations will be analyzed by flow cytometry and the quantification of blood cell populations will be performed by an automated hematological cell counter on fresh blood samples. The medical and nurse team member as well as the lab techniques will not be aware of which group participants belong to.

The interviews with patients, who completed the four sessions of (EG1) and (EG2), and with informal caregivers, will be conducted two weeks after T1, by a different researcher than the one involved in the intervention, to reduce the bias of social desirability.

Data analysis:

All standard statistical analyses will be done using the IBM SPSS statistics 24 and IBM SPSS Amos 24. The comparison between (PCG) and (EG1) and (EG2) and (ACG) over time, will be analyzed through Generalized Mixed Models.

A semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from interventions (EG1, EG2) and the informal caregivers indicated by the patient that help with DFU care. This script will remain unchanged throughout the interviews. The audio recording of the interviews will be done using a tablet, transcribed verbatim and anonymized in order to safeguard participants and data confidentiality. The transcripts of the interviews will be analyzed in the same order as conducted, using the thematic content analysis technique.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Parallel Assignment This is a Randomized Controlled Study of a Psychological Intervention (Grant et al., 2018). This study will use a mixed-methods approach nested in a 4-arm randomized control design. Qualitative and quantitative data will be collected in order to provide better understanding about the effectiveness of the hypnosis intervention in patients with DFU.

Participants will be randomised at a ratio of 1:1 for the four conditions - EG1, EG2, ACG and PCG; and will be evaluated on the day of the first chronic DFU appointment or nursing treatment (T0), two months later (at the end of the intervention in EG, EG2 and ACG; T1), as well as six months later (T2) in a follow-up evaluation. Participants from all four groups will undergo standard treatment for the DFU, according to the guidelines of the Portuguese General Health Direction (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015).

• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double (Participant, Outcomes Assessor) Eligible participants will be randomized into the four groups into blocks of variable size, multiples of three; and will be stratified according to: i) data collection site; ii) Chronic Renal Disease; and iii) Peripheral Arterial Disease; because they are factors of poor prognosis in the DFU healing (Ferreira et al., 2014). This procedure will be performed using an online random number generator, by a researcher external to the team involved in the implementation of this study, in order to ensure the concealment of the allocation of participants by the various groups (Pandis, 2012). After this procedure, it will not be possible to conceal the group to which the patient belongs from the researcher who will perform the psychological intervention. However, health professionals (doctors and nurses) will be blinded during the entire procedure, because they fill in the RESVECH 2.0, which assesses the DFU healing.
• Primary Purpose: Treatment
• Official Title: Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer, in Physiological Indicators of Healing Prognosis and Quality of Life: a Randomized Longitudinal Trial With a Nested Qualitative Study of Effectiveness Assessment
• Actual Study Start Date: February 1, 2019
• Estimated Primary Completion Date: October 1, 2021
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Muscle Relaxation with Guided Imagery; The participants in Experimental Group will receive four individual 45-minute sessions, every two weeks, of progressive muscle relaxation intervention with guided imagery focused on ulcer healing, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.	Behavioral: Muscle Relaxation with Guided Imagery; Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot).The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds.The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
Experimental: Hypnosis with Guided imagery; The participants in Experimental Group will receive a four individual 45-minute sessions, every two weeks, of hypnotic intervention with guided imagery focused on ulcer healing, carried out by the Hypnotherapist on the day of the Diabetic Foot appointments.	Behavioral: Hypnosis with Guided Imagery; In the beginning of the first session we apply the Eye-Roll Test for Hypnotizability of Herbert Spiegel. Each session follows the Hypnotic Protocol with the following steps:Pre-talk/Absortion/Ratification/Aliciation/Dissociation/Awakening. The four sessions train the participants in visual, auditory and kinesthetic perception on ulcer healing. The protocol also promotes medical treatment acceptance.
Placebo Comparator: Active Control Group; Participants in the Active Control Group will receive four individual 45-minute sessions of neutral guided imagery placebo, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments.	Behavioral: Neutral Guided Imagery; This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.
No Intervention: Passive Control Group; The participants in the Passive Control Group will not receive any intervention nor placebo session.

Outcome Measures

Primary Outcome Measures :

1. Rate of eligibility [ Time Frame: Baseline (T0) ]
   This rate will result from the proportion between the number of eligible patients and the total number of observed patients, in percentage.
2. Rate of recruitment [ Time Frame: Baseline (T0)] ]
   This rate will result from the proportion between the number of patients who accepted to participate and the number of eligible patients, in percentage.
3. Rate of refusal [ Time Frame: Baseline (T0)] ]
   This rate will result from the proportion between the number of patients who rejected to participate in the study and the number of patients invited to participate, in percentage.
4. Rate of adherence to the study protocol [ Time Frame: Through study completion, an average of 6 months ]
   This rate will result from the proportion between the number of patients who performed the assessments/intervention sessions and the number of patients who completed the baseline assessment (T0), in percentage.
5. Rate of participation in follow-up [ Time Frame: Through study completion, an average of 6 months ]
   This rate will result from the proportion between the number of patients who participated in follow-up assessment and the number of patients who completed the baseline assessment (T0), presented in percentage.
6. Rate of dropout [ Time Frame: Through study completion, an average of 6 months ]
   This rate will result from the proportion between the number of patients who dropout the study and the number of patients who completed the baseline assessment (T0), presented in percentage.
7. Inflammatory markers [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   C-reactive protein, SDF-1 and TNF-a levels evaluated in the plasma by ELISA. Blood lymphocyte populations assessed in the whole blood by flow cytometry and automated hematological cell counter.
8. Oxidative Stress marker [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   Oxidative stress (AGE) evaluated in the plasma. The assessment of AGE is indirect.
9. Angiogenic markers [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   VEGF levels assessed in the plasma by ELISA (Cell Signaling ELISA kits).
10. Metabolic markers [ Time Frame: Only at baseline (T0) ]
    HbA1c, glucose and, lipid profile: total cholesterol, HDL, LDL and triglycerides evaluated in the whole blood
11. miRNA markers [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
    miRNA-21 and miRNA-155 assessed. The control gene will be RNU6B.

Secondary Outcome Measures :

1. Degree of DFU healing [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The degree of DFU healing will be assessed with the Portuguese version of "Resultados esperados de la valoración y evolución de la cicatrización de las heridas crónicas" Scale [Expected results of the evaluation and evolution of the healing of chronic wounds Scale - RESVECH 2.0] (Marques, 2015). The scores range from 0 to 35, where zero indicates complete healing.
2. Impact of DFU on patients' Quality of Life [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The Diabetic Foot Ulcer Scale-Short Form (DFS-SF; Bann, Fehnel, & Gagnon, 2003; Research version by Pereira & Ferreira, 2018) will be used to assess patients´ DFU-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better DFU-related quality of life.
3. Physical Quality of Life [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, & Pereira, 2012) will be administered to assess patients' physical Health-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better physical quality of life.
4. Mental Quality of Life [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, & Pereira, 2012) will be administered to assess patients' mental Health-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better mental quality of life.
5. Perceived Stress [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The overall stress perceived by the patient will be assessed through the Perceived Stress Scale (PSS; Trigo, Canudo, Branco, & Silva, 2010). Scores range between 0 and 40, with higher results indicating higher levels of perceived stress.
6. Emotional Distress [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The emotional distress will be assessed through the total score of the Hospital Anxiety and Depression Scale, comprising both anxiety and depression scales (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 42, with higher results indicating higher levels of distress.
7. Anxiety symptoms [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The anxious symptomatology will be assessed through the Hospital Anxiety and Depression Scale (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 21, with higher results indicating higher levels of anxiety symptoms.
8. Depression symptoms [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The depressive symptomatology will be assessed through the Hospital Anxiety and Depression Scale (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 21, with higher results indicating higher levels of depression symptoms.
9. Adherence to DFU Care [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   Patient adherence to DFU care will be assessed through the DFU Care Adherence Questionnaire (Research Version by Pereira, Dantas, Brandão, Santos, Carvalho, & Ferreira, 2018), which was developed for this study, according to the guidelines of the Portuguese General Direction of Health (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015). Higher scores indicate better adherence to DFU care.
10. Representations regarding the DFU [ Time Frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
    Patient representations regarding the DFU will be evaluated through the Illness Perception Questionnaire - Brief (IPQ-B; Figueiras et al., 2010). The response scale ranges from 0 to 10. Higher scores indicate more threatening representations regarding DFU.
11. Systolic Pressure [ Time Frame: Before and after each intervention at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0) ]
    Systolic pressure in millimeters of mercury (mmHg) will be assessed through a validated and certified blood pressure measuring device.
12. Diastolic Pressure [ Time Frame: Before and after each intervention at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0) ]
    Diastolic pressure in millimeters of mercury (mmHg) will be assessed through a validated and certified blood pressure measuring device.
13. Heart rate [ Time Frame: Before and after each intervention at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0) ]
    Heart rate in beats per minute (bpm) will be assessed through a validated and certified blood pressure measuring device.

Other Outcome Measures:

1. Sociodemographic Data [ Time Frame: Baseline (T0) ]
   The following socio-demographic data will be collected: gender; age; living environment; marital status; professional status; monthly income; if there is an informal caregiver, what is the degree of kinship with the caregiver and the quality of the patient's relationship with the caregiver; as well as some questions regarding access to health care.
2. Health Literacy [ Time Frame: Baseline (T0) ]
   The level of health literacy will be assessed through the Medical Term Recognition Test (METER; Paiva et al., 2014).
3. Clinical Data [ Time Frame: Baseline (T0), end of intervention/ 2 months later at post-test (T1), and after 6 months follow-up (T2) ]
   The clinical data collected through a clinical questionnaire developed for this study will be: alcohol and tobacco consumption, presence and intensity of ulcer-related pain, and other symptomatic foot complaints; the type and duration of diabetes, HbA1c levels, duration of diabetic foot ulcer, type of foot and type of ulcer (PEDIS classification), location of the ulcer, recognised complications and comorbidities, type of treatment provided at the consultation, number of medical and nursing visits, date of DFU healing, and appearance of new ulcers. Psychophysiological parameters such as transcutaneous O2 pressure (TCPO2) where appropriate; blood pressure and heart rate; will also be assessed, the latter two being evaluated by an automatic blood pressure measuring device.
4. Eye-roll test for hypnotizability [ Time Frame: Before the intervention (EG2) at 2 weeks, after the baseline (T0) ]
   The degree of patient's hypnotizability will be assessed by Eye-roll test hypnotizability (Spiegel,1972)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diabetes Mellitus diagnosis;
• Diagnosis of Diabetic Foot;
• Having one or two active chronic ulcers (> 6 weeks) at the time of the assessment;
• Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Hospital de Braga;
• Presenting clinical levels of stress (scores greater than 13 for males and greater than 17 for females on the Perceived Stress Scale) or anxiety or depression (scores greater than 11 on Hospital Anxiety and Depression Scale).

Exclusion Criteria:

The active DFU at the time of the assessment being a relapse;

• Having more than two DFU currently active;
• Being on hemodialysis treatment;
• Presence of psychosis or dementia described in the patient's medical record;
• Having cancer disease;
• Having undergone a transplant;
• Receiving psychological counselling at the time of the assessment.

For the qualitative study nested in RCT, twelve participants must meet the same inclusion and exclusion criteria defined above, plus being allocated to the EG1 or EG2 or ACG or PCG. From those participants, the following cases will be selected:

• Two typical cases of successful and unsuccessful patients with neuropathic foot defined by the presence of neuropathic pain (e.g., heat, tingling, electrical shock), presence of distal pulses by palpation, and loss of protective sensitivity;
• Two typical cases of successful and unsuccessful patients with neuroischemic foot defined by the presence of peripheral artery disease, intense-variable pain, absence of distal pulses by palpation, and variable protective sensitivity.

Contacts and Locations

Contacts

Contact: M. Graça Pereira, PhD; 938471039 ext +351; gracep@psi.uminho.pt

Locations

Portugal

Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa; Recruiting

Penafiel, Portugal, 4564-007

Contact: Maria de Jesus Dantas, MD 70595@chts.min-saude.pt

Centro Hospitalar Universitário do Porto; Recruiting

Porto, Portugal, 4099-001

Contact: André Carvalho, PhD andre.carvalho@chporto.min-saude.pt

Sponsors and Collaborators

University of Minho

Foundation for Science and Technology (Portugal)

Investigators

• Study Director: M. Graça Pereira, PhD; School of Psychology, University of Minho

More Information

Publications:

Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90.

Bardin L. Análise de Conteúdo [Content Analysis]. 2016; São Paulo, Brasil: Almedina. Brasil.

Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. Review.

Direção-Geral de Saúde, DGS [General Health Direction, Portugal] Circular Normativa Nº:05/PNPCD: Pé Diabético, Programa Nacional de Prevenção e Controlo da Diabetes (PNPCD) [Normative Circular Nº: 05 / PNPCD: Diabetic Foot, National Diabetes Prevention and Control Program]; 2010. Retrieved from http://www.dgs.pt/?cr=15718

Ferreira P. A medição do estado de saúde: Criação da versão portuguesa do MOS SF-36 [Measuring health status: Creation of the Portuguese version of MOS SF-36]. Coimbra: Centro de Estudos e Investigação em Saúde, Faculdade de Economia, Universidade de Coimbra; 1998. Ferreira PL, Ferreira LN, Pereira LN. Medidas sumário física e mental de estado de saúde para a população portuguesa [Physical and mental summary measures of health state for the Portuguese population]. Revista Portuguesa de Saúde Pública. 2012;30(2):163-171. doi:10.1016/j.rpsp.2012.12.007.

Ferreira V, Martins J, Loureiro L, Loureiro T, Borges L, Silveira D, … Almeida R. Consulta multidisciplinar do pé diabético: Avaliação dos fatores de mau prognóstico [Multidisciplinary consultation of diabetic foot - factors related with bad prognosis]. Angiologia e Cirurgia Vascular. 2014;10:146-150. doi:10.1016/ j.ancv.2014.08.005

Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.

Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.

International Working Group on the Diabetic Foot [IWGDF] International Consensus on the Diabetic Foot. International Diabetes Foundation; 2015. Retrieved from http://www.iwgdf.org/files/2015/website_prevention.pdf

Marques JM. Adaptação cultural e validação para a população portuguesa de um instrumento de monitorização de feridas crónicas - escala RESVECH 2.0 [Cultural adaptation and validation for the Portuguese population of a chronic wound monitoring instrument - RESVECH 2.0 scale] (Master's Thesis). Instituto de Ciências da Saúde da Universidade Católica, Porto; 2015.

Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. English, Portuguese.

Paiva D, Silva S, Severo M, Ferreira P, Santos O, Lunet N, Azevedo A. Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Educ Couns. 2014 Nov;97(2):269-75. doi: 10.1016/j.pec.2014.07.024. Epub 2014 Jul 22.

Pandis N. Randomization. Part 3: allocation concealment and randomization implementation. Am J Orthod Dentofacial Orthop. 2012 Jan;141(1):126-8. doi: 10.1016/j.ajodo.2011.09.003.

Spiegel H. An eye-roll test for hypnotizability. Am J Clin Hypn. 1972 Jul;15(1):25-8.

Trigo M, Canudo N, Branco F, Silva D. Estudo das propriedades psicométricas da Perceived Stress Scale (PSS) na população Portuguesa [Psychometric proprieties of the Perceived Stress Scale (PSS) in Portuguese population]. Psychologica. 2010;53:353-378. doi:10.14195/1647-8606_53_17

• Responsible Party: Maria da Graça Pereira, Associate Professor with Aggregation of School of Psychology, University of Minho
• ClinicalTrials.gov Identifier: NCT04698720
• Other Study ID Numbers: PTCD/PSIGER/ 28163/2017
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria da Graça Pereira, University of Minho:

Diabetic Foot Ulcer; Ulcer Healing; Quality of Life; Hypnosis; Relaxation

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases