Topical Administration of Teucrium polium on Diabetic Foot Ulcers Accelerates Healing: A Placebo-Controlled Randomized Clinical Study

Author(s):  
Hasan Fallah Huseini ◽  
Maryam Yaghoobi ◽  
Farhad Fallahi ◽  
Farzaneh Boroumand ◽  
Mohammad Hassan Ezzati ◽  
...  

Diabetic foot ulcer is one of the most devastating complications of uncontrolled diabetes. Although there have been advances in the management of diabetic foot ulcers, still diabetic foot ulcers are a major cause of many amputations in diabetic patients. Teucrium polium ( T. polium) is widely used by folk medicine practitioners in Iran for the treatment of diabetic ulcers. The present study was designed to evaluate the safety and efficacy of topical T. polium ointment besides the standard treatment in diabetic foot ulcers. A total of 70 diabetic patients with foot ulcers grade 1 or 2 according to Wagner's scale were enrolled in this study. Patients were randomly divided into two groups. Patients in both groups received standard treatment for diabetic foot ulcers. In addition, group 1 received topical T. polium ointment, and group 2 received topical placebo ointment for 4 weeks. The T. polium and placebo ointments were rubbed twice daily two hours before the conventional dressing. The ulcer size, healing time, and laboratory tests were measured in both groups at baseline and end of the study after 4 weeks. Twenty-nine patients remained in the T. polium group and 26 in the placebo group until the end of the study. The mean surface area of ulcers was 3.52 ± 1.47 and 3.21 ± 1.67 cm2 in T. polium group and placebo group respectively at baseline which decrease to .717 ± .19 and 1.63 ± .72 cm2 respectively at the endpoint. The mean ulcer surface area was significantly lower in T. polium compared with the placebo group ( p < .0001) at end of the study. Also, the number of patients that completely recovered in the T. polium group was significantly higher than the placebo group ( p < .001) at the end of the study. The addition of topical T. polium ointment to standard treatment significantly improves the healing time of diabetic non-infected foot ulcers.

2000 ◽  
Vol 21 (4) ◽  
pp. 320-323 ◽  
Author(s):  
Rutger Jan Hissink ◽  
Hendrik Anton Manning ◽  
Jeff G. van Baal

INTRODUCTION: Total Contact Casting (TCC) is considered the gold standard in the treatment of neuropathic diabetic foot ulcers. To overcome some disadvantages of TCC we developed a removable fiberglass combicast shoe - the MABAL shoe. PATIENTS AND METHODS: The MABAL shoe was used to treat 23 plantar ulcers. RESULTS: Before treatment the mean surface area was 2.0 cm 2 (0.5–7.1 cm 2 ). Twenty-one of 23 ulcers healed, with a mean healing time of 34 days (7–75 days). CONCLUSION: The MABAL shoe provides healing of neuropathic diabetic foot ulcers comparable to existing methods of treatment, while offering some potential advantages. The main advantages are mobilization of the ankle, removability of the cast and a less time consuming form of treatment.


2019 ◽  
Author(s):  
Jocefabia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra

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.


Trials ◽  
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

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.


2017 ◽  
Vol 39 (1) ◽  
pp. 83-92 ◽  
Author(s):  
Carlo Biz ◽  
Stefano Gastaldo ◽  
Miki Dalmau-Pastor ◽  
Marco Corradin ◽  
Andrea Volpin ◽  
...  

Background: The aims of this prospective study were first to evaluate the safety and effectiveness of minimally invasive distal metatarsal diaphyseal osteotomies (DMDOs) for treating a consecutive series of diabetic patients with chronic plantar diabetic foot ulcers (CPDFUs) and second to assess their clinical-functional and radiographic outcomes. Methods: A consecutive series of patients affected by diabetes mellitus with CPDFUs, not responsive to previous nonoperative management, underwent DMDO. The CPDFUs were evaluated using the University of Texas Diabetic Wound Classification System (UTDWC). Demographic parameters, Foot & Ankle Society (AOFAS) scores, visual analog scale (VAS) scores, healing times, and complications were recorded. Maestro et al criteria and bone callus formation were analyzed radiologically. Statistical analysis was carried out ( P < .05). Thirty consecutive enrolled patients with a mean age of 66.7 (range, 53-75) years presented 35 CPDFUs with a mean diameter of 16.3 mm and a mean duration of 10.3 months. The most frequent grade of the UTDWC was IIIB (42.9%). Results: All ulcers recovered with a mean healing time of 7.9 ± 4.0 (range, 4-17) weeks. AOFAS scores improved significantly from 55.3 to 81.4 points ( P < .001). At a mean follow-up of 25.3 months (range, 18-71), no cases of ulcer recurrence were recorded, while a major complication or a wound infection required longer healing time. Conclusion: Minimally invasive DMDO was a safe and effective method in promoting CPDFU healing, regardless of the grade of severity, by the reduction of the high plantar pressure under the metatarsal heads. This technique improved functional and radiographic outcomes with few complications. Level of Evidence: IV, case series.


2020 ◽  
Author(s):  
Jocefabia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra

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


2020 ◽  
Author(s):  
Jocefabia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra

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.


Author(s):  
Tharun Ganapathy Chitrambalam ◽  
Pradeep Joshua Christopher ◽  
Jeyakumar Sundaraj ◽  
Ramyasree Paladugu ◽  
Sundeep Selvamuthukumaran

Introduction: Diabetic foot ulcers are associated with 25% of patients with Diabetes Mellitus (DM). These diabetic foot ulcers if not given appropriate care at the right time can lead to amputations and poor quality of life. Alginate dressings are newer and help in faster healing of cavity wounds in diabetic foot ulcer. Aim: To compare the advantages of alginate dressings over conventional saline dressings in cavity wounds of diabetic foot ulcer patients. Materials and Methods: A single centre prospective longitudinal cohort study was conducted on 88 patients with diabetic foot ulcers randomising equally into two groups containing 44 patients in each group in a tertiary care hospital. The wounds of all patients included in the study were thoroughly debrided and initial assessment was done using the Pressure Ulcer Scale for Healing (PUSH) scoring system. The patients were started on alginate dressings in one group and saline dressings in other group and were assessed after two and four weeks. The reduction in the surface area of the wound, reduction in the exudate amount, type of the tissue over the ulcer and reduction in the bacterial load (wound cultures) of the ulcers were studied. The statistical analysis were done using Statistical Package for the Social Sciences (SPSS) software version 21. The statistics were done using independent sample tests (Levene’s test for equality of variances and t-test for equality of means), Mann-Whitney test and Wilcoxon test. Results: The results of wound assessment before dressings, at two weeks and at the end of four weeks are as follows: The mean (SD) reduction in wound surface area was 9.07 (1.634) to 6.89 (1.434) to 4.68 (1.272) for alginate group and 9.25 (2.059) to 8.00 (1.905) to 6.50 (1.650) for saline group. The mean (SD) reduction of the exudate amount was 2.02 (0.505) to 1.09 (0.473) to 0.14 (0.347) for alginate group and 1.98 (0.590) to 1.43 (0.625) to 0.75 (0.615) for the saline group. The mean (SD) for tissue type of cavity wounds assessed via PUSH scoring was reduced from 2.30 (0.701) to 0.16 (0.370) for the alginate group in comparison to 2.32 (0.740) to 0.77 (0.743) for the saline group at the end of four weeks. On evaluation of the wound cultures; 6 out of 44 patients (13.6%) were culture positive in the alginate group while 30 out of 44 patients (68.2%) were culture positive from the saline group at the end of four weeks. All the above results were statistically significant with a p-value of 0.001. Conclusion: Alginates dressings are superior to saline dressings in terms of reduction in the size of the ulcer and control of microbial activity in diabetic foot. Alginate absorbs large amount of exudates and fill in irregular shaped cavities which are ideal in treating cavity wounds in diabetic foot syndrome.


2021 ◽  
Vol 8 (34) ◽  
pp. 3200-3204
Author(s):  
Bathena Sobha Rani ◽  
Gandikota Venkata Prakash ◽  
Budamala Sarada ◽  
Bharath Kumar Desu ◽  
Yadhuf Krishnan

BACKGROUND Diabetic patients have reduced ability to metabolize glucose resulting in elevated blood sugar levels which further burdens the wound healing process. This leads to non-healing chronic ulcers. The sufferers of chronic diabetic foot ulcers are increasing globally due to lack of preventive and control measures. Sucralfate has been demonstrated in molecular studies to enhance the granulation tissue proliferation and thus promoting ulcer healing in the skin. Various clinical studies have also showed the efficacy of sucralfate in complete healing of the wound and in reducing the size of the wound. The purpose of this study was to compare the efficacy of topical sucralfate with that of povidone iodine dressing, in the healing of diabetic ulcers. METHODS This is a randomized comparative study. Among 100 patients, 50 patients received treatment in the form of povidone iodine dressings and 50 took treatment with sucralfate dressing. The patient underwent a detailed clinical examination. Relevant investigations were also done. The initial wound area was recorded after thorough debridement by measuring length x width. Both the groups underwent dressings once daily. The patients were followed up daily for a period of 3 weeks in both the groups. RESULTS In this study, the mean ± SD area of reduction of the ulcer was observed to be higher in sucralfate group 54.17 ± 10.08 than the povidone iodine group 16.07 ± 4.19. There was a statistically significant difference between the groups for the mean of area reduction (P < 0.0001, significant). CONCLUSIONS The ulcers in subjects treated with sucralfate dressing (S group) contracted more than the ulcers in the patients treated with povidone iodine (P group) (54.17 % Vs 16.07 %; P = < 0.0001, significant) which points out that sucralfate dressing is an effective modality in helping the reduction of wound area in patients with diabetic foot ulcers. KEYWORDS Diabetic, Sucralfate, Area of Reduction


2020 ◽  
Author(s):  
Jocefabia Reika Alves Lopes ◽  
Mariza D’Agostino Dias ◽  
João Antonio Correa ◽  
Maria Alice Bragagnolo Batalha ◽  
Luanda Karla Dantas Guerra

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


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ahmed Shabhay ◽  
Pius Horumpende ◽  
Zarina Shabhay ◽  
Andrew Mganga ◽  
Jeff Van Baal ◽  
...  

Abstract Background Diabetic foot ulcers complications are the major cause of non-traumatic major limb amputation. We aimed at assessing the clinical profiles of diabetic foot ulcer patients undergoing major limb amputation in the Surgical Department at Kilimanjaro Christian Medical Centre (KCMC), a tertiary care hospital in North-eastern Tanzania. Methods A cross—sectional hospital-based study was conducted from September 2018 through March 2019. Demographic data were obtained from structured questionnaires. Diabetic foot ulcers were graded according to the Meggitt-Wagner classification system. Hemoglobin and random blood glucose levels data were retrieved from patients’ files. Results A total of 60 patients were recruited in the study. More than half (31/60; 51.67%) were amputated. Thirty-five (58.33%) were males. Fifty-nine (98.33%) had type II diabetes. Nearly two-thirds (34/60; 56.67%) had duration of diabetes for more than 5 years. The mean age was 60.06 ± 11.33 years (range 30–87). The mean haemoglobin level was 10.20 ± 2.73 g/dl and 9.84 ± 2.69 g/dl among amputees. Nearly two thirds (42/60; 70.00%) had a haemoglobin level below 12 g/dl, with more than a half (23/42; 54.76%) undergoing major limb amputation. Two thirds (23/31; 74.19%) of all patients who underwent major limb amputation had mean hemoglobin level below 12 g/dl. The mean Random Blood Glucose (MRBG) was 13.18 ± 6.17 mmol/L and 14.16 ± 6.10 mmol/L for amputees. Almost two thirds of the study population i.e., 42/60(70.00%) had poor glycemic control with random blood glucose level above 10.0 mmol/L. More than half 23/42 (54.76%) of the patients with poor glycemic control underwent some form of major limb amputation; which is nearly two thirds (23/31; 74.19%) of the total amputees. Twenty-eight (46.67%) had Meggitt-Wagner classification grade 3, of which nearly two thirds (17:60.71%) underwent major limb amputation. Conclusion In this study, the cohort of patients suffering from diabetic foot ulcers treated in a tertiary care center in north-eastern Tanzania, the likelihood of amputation significantly correlated with the initial grade of the Meggit-Wagner ulcer classification. High blood glucose levels and anaemia seem to be also important risk factors but correlation did not reveal statistical significance.


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