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

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

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

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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

Resource links provided by the National Library of Medicine


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.



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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698720


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

Locations
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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
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Study Director: M. Graça Pereira, PhD School of Psychology, University of Minho
Publications:
Bardin L. Análise de Conteúdo [Content Analysis]. 2016; São Paulo, Brasil: Almedina. Brasil.
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
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.
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

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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    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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