Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

Abstract Background Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The primary aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers, in addition to secondarily evaluating whether it reduces the number of amputations and improves the quality of life in these patients. Methods A non-blind randomized clinical study will be conducted in the city of Imperatriz, Maranhão state, Brazil, from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grades 2, 3 and 4, persisting for more than 1 month). The outpatient follow-up for diabetic foot patients will be done at the Unified Health System, with a sample size of 120 patients (the randomization allocation will be 1:1, being 60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after 6 months and 1 year. The patients of the control group will also be evaluated at equivalent periods (upon admission, after 2, 4, 6 and 7 weeks, 6 months and 1 year). The SF-36 quality of life questionnaire will be filled upon admission and after 3 months of follow-up in both groups. The primary and secondary endpoints will be assessed with 1 year of follow-up. Discussion Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers. Trial registration Registration number RBR-7bd3xy. Registered on 17 July 2019—Retrospectively registered.

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Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

10.21203/rs.2.16819/v4 ◽

2020 ◽

Author(s):

Jocefabia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Diabetic Foot ◽

Oxygen Therapy ◽

Standard Treatment ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

Diabetic Foot Ulcers ◽

One Year

Abstract Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The primary aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers, in addition to secondarily evaluating whether it reduces the number of amputations and improves the quality of life in these patients.Methods: A non-blind randomised clinical study will be conducted in the city of Imperatriz, Maranhão state, Brazil from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the Unified Health System, with a sample size of 120 patients (the randomisation allocation will be 1:1, being 60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months and one year. The patients of the control group will also be evaluated at equivalent periods (upon admission, after 2, 4, 6 and 7 weeks, six months and one year). The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. The primary and secondary endpoints will be assessed with 1 year of follow-up.Discussion: Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers. Trial registration: Registration number RBR-7bd3xy. Registered 17 July 2019 – Retrospectively registered, http://www.ensaiosclinicos.gov.br/rg/RBR-7bd3xy

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Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

10.21203/rs.2.16819/v2 ◽

2020 ◽

Author(s):

Jocefabia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Diabetic Foot ◽

Oxygen Therapy ◽

Standard Treatment ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

Diabetic Foot Ulcers ◽

One Year

Abstract Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The primary aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers, in addition to secondarily evaluating whether it reduces the number of amputations and improves the quality of life in these patients. Methods: A non-blind randomised clinical study will be conducted in the city of Imperatriz, Maranhão state, Brazil from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the Unified Health System, with a sample size of 120 patients (the randomisation allocation will be 1:1, being 60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months and one year. The patients of the control group will also be evaluated at equivalent periods (upon admission, after 2, 4, 6 and 7 weeks, six months and one year). The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. The primary and secondary endpoints will be assessed with 1 year of follow-up. Discussion: Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.

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Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

10.21203/rs.2.16819/v3 ◽

2020 ◽

Author(s):

Jocefabia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Diabetic Foot ◽

Oxygen Therapy ◽

Standard Treatment ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

Diabetic Foot Ulcers ◽

One Year

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Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol

10.21203/rs.2.16819/v1 ◽

2019 ◽

Author(s):

Jocefabia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Hyperbaric Oxygen ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Standard Treatment ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

Diabetic Foot Ulcers

Abstract Background: Diabetic limb ulcers are highly prevalent and contribute to a significant increase in cost for the treatment of these patients in health services. However, healing of these wounds is a major health problem and may even lead to amputation. The aim of the current study is to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in facilitating the healing of diabetic foot ulcers and reducing the number of amputations in these patients.Methods : The study will be conducted in the city of Imperatriz, Maranhão from 2019 to 2020, in diabetic patients with chronic foot ulcers (classified as Wagner grade 2, 3, and 4, persisting for more than one month). The outpatient follow-up for diabetic foot patients will be done at the SUS (Unified Health System), with a sample size of 120 patients (60 patients for each arm). Half of the patients will receive standard treatment, i.e. dressings, debridement, antibiotics, and load relief, along with HBOT (HBOT group), and the other half will receive only standard treatment (control group). The patients of the HBOT group will be evaluated upon admission, after 10, 20, 30 and 35 HBOT sessions, and after six months. The patients of the control group will also be evaluated at equivalent periods. The progression of the wounds and specific treatment, such as appropriate bandage, antibiotic therapy, or need of some surgical intervention will be evaluated on a weekly basis. The SF-36 quality of life questionnaire will be filled upon admission and after three months of follow-up in both groups. Upon admission, the patients of both groups will undergo arterial Doppler ultrasound, and laboratory tests–complete blood count, erythrocyte sedimentation rate, C-reactive protein, creatinine, fasting blood glucose, and glycosylated haemoglobin.Discussion : Diabetic foot ulcers are a highly prevalent complication of diabetes with serious consequences. A study to assess the efficacy of HBOT in healing the ulcers and reducing the rate of amputations in diabetic patients is justified, which will eventually aid in the development of guidelines for treating these ulcers.

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Association of traditional complementary and alternate medicine usage with quality of life of diabetic patients in a Malaysian tertiary hospital

Nutrition & Food Science ◽

10.1108/nfs-03-2021-0104 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Chinedum Ogbonnaya Eleazu ◽

Aniza Abd Aziz ◽

Tay Chuu Suen ◽

Lam Chun-Hau ◽

Chin Elynn ◽

...

Keyword(s):

Quality Of Life ◽

Diabetic Foot ◽

Heart Diseases ◽

Tertiary Hospital ◽

Foot Ulcers ◽

Diabetic Patients ◽

Diabetic Foot Ulcers ◽

Content Type ◽

Significant Difference

Purpose This study aims to design to assess the traditional, complementary and alternate medicine (TCAM) usage and its association with the quality of life (QOL) of Type 2 diabetic patients in a tertiary hospital (Hospital Universiti Sains Malaysia) in Malaysia. Design/methodology/approach A total of 300 respondents included in this study were divided into the following two major categories: TCAM (34.33% of respondents) and non-TCAM users (65.67% of the respondents), respectively. The mean ages of the respondents were 59.3 ± 10.2 for the TCAM users and 57.7 ± 12.0 for the non-TCAM users. Findings A greater percentage of non-TCAM users reported poor control of diabetes (14.7%) and blood glucose (55.8%) compared with the TCAM users (9.7% and 48.5%, respectively). Further, the diabetic patients on TCAM reported lower rates of coma, stroke and kidney problems but higher rates of diabetic foot ulcers, heart diseases and retinopathy than the non-TCAM users. Additionally, the diabetic patients with TCAM usage had a significantly better physical (p = 0.02) and overall (p = 0.03) qualities of life compared to the non-TCAM users. However, psychological, social and environmental health did not show any significant difference. Originality/value The prevalence of TCAM usage among diabetic patients was lower than in other comparable studies. Diabetic patients on TCAM reported lower rates of coma, stroke and kidney problems but higher rates of diabetic foot ulcers, heart diseases and retinopathy than the non-TCAM users. Further, diabetes patients on TCAM reported better QOL compared to non-TCAM users especially in terms of physical health.

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Relationship between hyperbaric oxygen therapy and quality of life in participants with chronic diabetic foot ulcers: data from a randomized controlled trial

Acta Diabetologica ◽

10.1007/s00592-017-1012-z ◽

2017 ◽

Vol 54 (9) ◽

pp. 823-831 ◽

Cited By ~ 8

Author(s):

Guowei Li ◽

Robert B. Hopkins ◽

Mitchell A. H. Levine ◽

Xuejing Jin ◽

James M. Bowen ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Controlled Trial ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Randomized Controlled

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The Role of VEGF and TNF-Alpha on Epithelialization of Diabetic Foot Ulcers after Hyperbaric Oxygen Therapy

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2019.297 ◽

2019 ◽

Vol 7 (19) ◽

pp. 3177-3183 ◽

Cited By ~ 1

Author(s):

I Nyoman Semadi

Keyword(s):

Hyperbaric Oxygen ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Oxygen Therapy ◽

Foot Ulcers ◽

Control Group ◽

Diabetic Patients ◽

High Morbidity ◽

Diabetic Foot Ulcers ◽

Tnf Α

BACKGROUND: Around 15-25% of diabetes mellitus (DM) patients will develop diabetic foot ulcers (DFUs) with high morbidity, many studies have been proposed to search the most effective healing techniques. AIM: This study was conducted to demonstrate the ability of hyperbaric oxygen therapy (HBOT) as a complementary therapy in DFUs healing through raising vascular endothelial growth factor (VEGF) levels and suppressing tumour necrosis factor-alpha (TNF-α). METHODS: All patients received the same treatment including wound debridement and wound care, but the patients in the HBOT group, breathed 100% oxygen at 2.4 ATA for 90 minutes in total of 20 sessions (four weeks). RESULT: There were 32 diabetic patients with DFUs Wagner 3-4. VEGF levels after four weeks of HBOT was significantly elevated compared to the control group (p = 0.013). The effect size of VEGF levels was p = 0.005. TNF-α levels after four weeks of therapy were decreased (p = 0.01). Faster epithelialization is seen in the HBOT group (p < 0.001). We also performed path analysis, HBOT had a significant effect on the epithelialization (p < 0.001) and VEGF levels affected the epithelialization process (p = 0.042). CONCLUSION: HBOT administration leads to increased VEGF levels, decreased TNF-α levels, and accelerated wound healing of DFUs patients. HBOT directly aids epithelialization and indirectly through VEGF upsurge and TNF-α downturn.

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Factors Associated With Quality of Life in Patients With Diabetic Foot Ulcers

Jundishapur Journal of Chronic Disease Care ◽

10.5812/jjcdc.26598 ◽

2015 ◽

Vol 4 (1) ◽

Cited By ~ 1

Author(s):

Fariba Nasiriziba ◽

Davood Rasouli ◽

Zahra Safaei ◽

Dariush Rokhafrooz ◽

Alireza Rahmani

Keyword(s):

Quality Of Life ◽

Diabetic Foot ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Factors Associated

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Associations of foot ulceration with quality of life and psychosocial determinants among patients with diabetes; a case-control study

Journal of Foot and Ankle Research ◽

10.1186/s13047-019-0367-5 ◽

2019 ◽

Vol 12 (1) ◽

Cited By ~ 1

Author(s):

Fahad D. Alosaimi ◽

Reem Labani ◽

Nouf Almasoud ◽

Nora Alhelali ◽

Lamya Althawadi ◽

...

Keyword(s):

Quality Of Life ◽

Diabetic Foot ◽

Case Control Study ◽

Self Management ◽

Foot Ulcers ◽

Anxiety And Depression ◽

Diabetic Foot Ulcers ◽

Psychosocial Determinants ◽

Control Study

Abstract Background Patients with diabetic foot ulcers may have a lower quality of life. The objective was to compare the quality of life and its psychosocial determinants among patients with and without diabetic foot ulcers. Methods A case-control study was conducted in 2017 among patients with (cases) and without (controls) diabetic foot ulcers. The study tools included the World Health Organization’s Quality of Life scale (WHOQOL-BREF), the Hospital Anxiety and Depression (HAD) scale for anxiety and depression, the Patient Health Questionnaire Physical Symptoms (PHQ-15) for the severity of somatic symptoms, and the Summary of Diabetes Self-Care Activities (SDSCA) measure for self-management. Results A total of 209 patients (45 cases and 164 controls) were included. The average age was 56.2 ± 11.7 years, and 55.5% were female. The average scores of WHOQOL-BREF, PHQ-15, and SDSCA were 74.4% ± 12.1% and 8.1 ± 6.1, and 30.4 ± 21.8, respectively. The prevalence of anxiety and depression were 19.6 and 24.9%, respectively. SDSCA was the only psychosocial determinants higher in cases than controls (mean difference = 15.0, 95% CI = -8.0–22.0). The correlation coefficients of WHOQOL-BREF scores with anxiety, depression, and PHQ-15 scores in all patients were − 0.559 (p < 0.001), − 0.582 (p < 0.001), and − 0.532 (p < 0.001), respectively, with similar numbers in both groups. In multivariate analysis, only the association between quality of life and depression was maintained. Conclusion Quality of life and psychosocial determinants with the exception of self-management were not associated with diabetic foot ulcers. Depressive symptoms were independent determinant of poor quality of life, irrespective of the status of diabetic foot ulcers.

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