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 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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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

Trials ◽

10.1186/s13063-020-04757-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Jocefábia Reika Alves Lopes ◽

Mariza D’Agostino Dias ◽

João Antonio Correa ◽

Maria Alice Bragagnolo Batalha ◽

Luanda Karla Dantas Guerra

Keyword(s):

Quality Of Life ◽

Diabetic Foot ◽

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 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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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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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

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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Role of hyperbaric oxygen therapy in the treatment of chronic ulcers of the foot in patients with type II diabetes mellitus

International Surgery Journal ◽

10.18203/2349-2902.isj20194398 ◽

2019 ◽

Vol 6 (10) ◽

pp. 3492

Author(s):

Said El Mallah ◽

Abd El Moniem Fareed ◽

Omar M. Abd Al-Halim Ghaly

Keyword(s):

Hyperbaric Oxygen ◽

Diabetic Foot ◽

Hyperbaric Oxygen Therapy ◽

Type Ii Diabetes ◽

Oxygen Therapy ◽

Foot Ulcers ◽

Diabetic Patients ◽

Type Ii ◽

Diabetic Foot Ulcers ◽

Significant Difference

Background: The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) in healing of chronic foot ulcers in patients with type II diabetes mellitus.Methods: A case control study included 40 type II diabetic patients with chronic foot ulcers not healing for more than 4 weeks. It has been conducted at Naser Institute for Research and Treatment and Menoufia University Hospital during the period between April 2017 and September 2018. Patients with non-healing diabetic foot ulcers were referred by physicians and were also identified through a number of wound care clinics in various hospitals.Results: Most ulcers were observed in the sole and heel in both groups A and B (n=14 and 9 respectively), while the rest of ulcers were distributed in other areas of the foot, namely the medial and lateral malleoli, dorsum and toes. On comparing the wound related complications developing during the treatment period, no statistically significant difference was found between both groups (p=0.147). As regards Wagner's grade, 7 patients (17.5%) had grade 4 ulcers, 18 patients (45%) had grade 3 ulcers and 15 patients (37.5%) had grade 2 ulcers, showing no statistically significant difference between both groups before treatment (p=0.259).Conclusions: HBOT is a useful adjunct in the treatment of non-healing diabetic foot ulcers, and that the cost of HBOT itself will be reduced as it becomes more widely available in the clinical setting, and as further knowledge of its other advantages, such as limited side effects and relative safety, become more widely appreciated.

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