scholarly journals Combination of Shengji ointment and bromelain in the treatment of exposed tendons in diabetic foot ulcers: Study protocol for a non-blind, randomized, positive control clinical trial

2021 ◽  
Author(s):  
yang zhao ◽  
rui gao ◽  
Xinyue Dai ◽  
Xu Sun ◽  
Zhaohui Zhang ◽  
...  
Keyword(s):  
Granulation Tissue ◽  
Diabetic Foot ◽  
Combined Treatment ◽  
Positive Control ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Foot Ulcers ◽  
Loss Of Function ◽  
Tendon Tissue ◽  
Factors Affecting

Abstract Background : Diabetic foot ulcers often affect tendon tissue. Consequently, the infection may spread proximally along the tendon, leading to amputation or even the death of patients. Exposed, degenerated, and necrotic tendons are key factors affecting the healing of diabetic foot ulcers. The effective treatment of the tendon involvement may positively affect the prognosis. In clinical practice, treatment with Shengji ointment and bromelain induces islands of granulation tissue on the denatured tendon surface, which gradually grows and merges. Ideally, the exposed tendon is covered entirely by granulation tissue. This trial aims to assess the effect of a combined treatment regime of Shengji ointment, which has been shown to regenerate muscle tissue and pineapple protease in preventing the loss of function and amputation caused by tendon necrosis. This trial will provide high-quality evidence for the effectiveness of this combination in healing diabetic ulcers with tendon necrosis. Methods: The sample size will be 180 patients who will be randomly assigned 1:1 to a treatment group (90 patients) using Shengji ointment combined with bromelain and a control group (90 patients) using hydrocolloid dressing. Both groups will continue their conventional treatments, such as blood glucose and blood pressure medication, lipid regulation, antiplatelets, and others. The primary outcome will be the wound coverage with granulation tissue. Secondary outcomes will be the wound healing rate, amputation extent (where needed), time to granulation, and the Maryland Foot Score. Other efficacy outcomes will be the time to debridement of necrotic tendon tissue and granulation tissue score. Discussion: This study will treat patients with diabetic foot ulcers with exposed, degenerated, and necrotic tendons with Shengji ointment and bromelain. The trial aims to promote regeneration and healing, to preserve the limb and its function, and to develop a comprehensive and effective protocol that can be applied to promote the healing of exposed tendons in diabetic foot wounds. Trial registration: ChiCTR2000039327; date of registration: 2020-10-23. http://www.chictr.org.cn/com/25/showproj.aspx?proj=62692

scholarly journals Effect of Health Education on Improving the Knowledge among Diabetes Mellitus Patients in the Prevention of Diabetic Ulcer in Regional Hospital of Tidore Island

2021 ◽  
Vol 4 (4) ◽  
pp. 379-384
Author(s):  
Haeril Amir ◽  
Nur Wahyuni Munir
Keyword(s):  
Diabetes Mellitus ◽  
Health Education ◽  
Diabetic Foot ◽  
Regional Hospital ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Patients ◽  
Diabetic Foot Ulcers ◽  
Diabetic Ulcer ◽  
Diabetic Ulcers

International  Diabetes  Federation  (IDF) reported that the number of diabetes mellitus patients worldwide increases every year. Diabetes mellitus is a chronic disease due to damage to the pancreas in producing enough insulin and characterized by impaired metabolism of fats, increased blood sugar, carbohydrates and protein both absolutely and relatively. Diabetic foot ulcers (DFU) are among the most common complications in diabetic patients and are associated with high mortality, morbidity, and health costs.   This study was to determine the effect of health education on knowledge improvement about diabetic ulcers in the regional hospital of Tidore Islands.  This research is a quasi-experimental type with a pretest-posttest without a control group design. The research sample consisted of 30 respondents who met the inclusion criteria. Data were analyzed using a paired test and processed with statistic version 21. Based on the research results, there was an improved knowledge in pre and post-health education counseling, where the average score before health education counseling was 11.6. After health counseling, the average value was 15.0. The results showed the effect of knowledge in the prevention of diabetic ulcers with a p-value =0,000.  Health education is an effort to improve patient's ability to prevent diabetic foot ulcers that have been proven in several scientific studies. Health education methods provide additional information so that patients who previously wondered about their disease can directly ask health workers. Health education affects the knowledge improvement of Diabetes Mellitus patients in the Regional hospital of Tidore Islands  

scholarly journals HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcers ◽  
Calotropis Procera ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Clinical Trial Registry ◽  
Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

scholarly journals 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

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.

scholarly journals Prospective Randomized Controlled Study of Hemostatic Efficacy with Kaolin-Impregnated Dressings in Diabetic Foot Ulcers Taking Anticoagulants Undergoing Debridement in an Outpatient Clinic

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Yeok Gu Hwang ◽  
Jin Woo Lee ◽  
Eun Ae Won ◽  
Seung Hwan Han
Keyword(s):  
Outpatient Clinic ◽  
Diabetic Foot ◽  
Ulcer Patient ◽  
Foot Ulcer ◽  
Controlled Study ◽  
Foot Ulcers ◽  
Control Group ◽  
Bleeding Tendency ◽  
Diabetic Foot Ulcers ◽  
Hemostatic Efficacy

Background. The effective hemostasis after minor debridement in an outpatient clinic is important and essential. This study is aimed at evaluating the hemostatic efficacy and safety of the kaolin-impregnated dressing for diabetic foot ulcer patient who take an anticoagulant. Methods. A prospective, randomized, clinical trial study was performed in twenty-six patients with diabetic foot ulcers who take an anticoagulant requiring minor debridement in an outpatient clinic. Minor debridement and removal of break down skin were performed by one orthopedic surgeon. Hemostasis on wound bed was achieved using kaolin-impregnated gauze (study group) and standard sterilized dry gauze (control group). Two randomized groups were compared for hemostatic efficacy and side effect. Results. For the purpose of this study, the presence or absence of hemostasis was assessed at 5 and 10 minutes after the application of dressing material. Treatment was evaluated as successful if bleeding was ceased adequately, and no extra hemostatic measures were required within 10 minutes. At 5 minutes, 80% of patients using the kaolin-impregnated gauze successfully achieved complete hemostasis versus 40% in the control group that controlled bleeding partially. With kaolin-impregnated gauze, 100% of patients show complete hemostasis at 10 minutes versus 58.3% in the standard gauze (P<.001). An adverse effect was not noted in all patients. Conclusions. The use of kaolin-impregnated gauze appears to be a safe and feasible option in managing bleeding after debridement of diabetic foot ulcers, and merits to patient who had a bleeding tendency is high. This trial is registered with CRIS registration number KCT0003894.

scholarly journals 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 ◽  
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.

Effect of Family Empowerment on HbA1c Levels and Healing of Diabetic Foot Ulcers

2020 ◽  
pp. 153473462093012
Author(s):  
Rasnah Appil ◽  
Elly Lilianty Sjattar ◽  
Saldy Yusuf ◽  
Kasmawati Kadir
Keyword(s):  
Wound Healing ◽  
Diabetic Foot ◽  
Healing Process ◽  
Intervention Group ◽  
Foot Ulcers ◽  
Control Group ◽  
Wound Healing Process ◽  
Diabetic Foot Ulcers ◽  
Family Empowerment ◽  
Hba1c Levels

Objective. To evaluate the effectiveness of family empowerment through educational interventions against HbA1c level and healing progress of diabetic foot ulcers. Method. A quasi-experimental design was employed involving 33 participants from 4 wound care clinics in Makassar, eastern Indonesia. The intervention group consisted of 17 participants and their families; the control group was composed of 16 participants who received nonstructural education. Family empowerment was measured by the Indonesian version of the Family Empowerment Scale instrument. Glycemic control was evaluated with HbA1c levels, and the wound healing process was evaluated on the Diabetic Foot Ulcers Assessment Scale. Result. After 3 months, Family Empowerment Scale scores improved, particularly in the subdomain of family knowledge (16.59 ± 3.92 vs 13.38 ± 1.26; P = .005) and attitude (3.65 ± 0.93 vs 2.75 ± 0.45; P = .002). After 3 months of intervention, HbA1c decreased (from 10.47 ± 2.44% to 8.81 ± 1.83%), compared with the control group ( P = .048). Meanwhile, an independent t test further revealed that the wound healing process tended to be better with the intervention group (4.71 ± 7.74) compared with the control group (17.25 ± 17.06), with P = .010 at the third month. Conclusion. Family-based education intervention creates family empowerment to control HbA1c levels and accelerate wound healing of diabetic foot ulcer.

The Role of Leukocyte-Platelet-Rich Fibrin in Promoting Wound Healing in Diabetic Foot Ulcers

2021 ◽  
pp. 153473462110528
Author(s):  
Yuqi Wang ◽  
Xiaotao Wang ◽  
Rong Chen ◽  
Liuwei Gu ◽  
Desen Liu ◽  
...  
Keyword(s):  
Wound Healing ◽  
Diabetic Foot ◽  
Early Stage ◽  
Treatment Method ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Foot Ulcers ◽  
External Application ◽  
Traditional Treatment ◽  
Platelet Rich Fibrin

To explore the effect of leukocyte-platelet-rich fibrin (L-PRF) on promoting wound healing in diabetic foot ulcers. A total of 42 patients with diabetic foot ulcers at our hospital from January 2017 to July 2020 were retrospectively analyzed. A control group and a PRF group were established. The two groups of patients underwent debridement. In the platelet-rich fibrin (PRF) group, autologous L-PRF was used to cover ulcer wounds. One time each week, Vaseline gauze was used to cover the ulcer wounds. In contrast, the control group was treated with the external application of mupirocin ointment and recombinant human epidermal growth factor gel (yeast). Two times each week, the sterile Vaseline gauze was covered with a bandage. Both groups were treated for 5 weeks. The wound recovery of the two groups was observed. During the early stage of treatment (first and second weeks) for diabetic foot ulcers, the wound healing rate was significantly better with L-PRF treatment than traditional treatment. For later-stage treatment (third to fifth weeks), the overall cure rate was higher with L-PRF than the traditional treatment method. L-PRF can effectively promote wound healing in diabetic foot ulcers.

scholarly journals Clinical Efficacy of a Kaolin-impregnated Dressing for Hemostatic Control in Diabetic Foot Ulcer Patients Receiving Anticoagulant Therapy in an Outpatient Clinic

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0002
Author(s):  
Yeokgu Hwang ◽  
Yoo Jung Park ◽  
Dong-Woo Shim ◽  
Jin Woo Lee ◽  
Seung Hwan Han
Keyword(s):  
Adverse Effects ◽  
Diabetic Foot ◽  
Anticoagulation Therapy ◽  
Foot Ulcer ◽  
Vascular Diseases ◽  
Diabetic Foot Ulcer ◽  
Surgical Debridement ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Foot Ulcers

Category: Diabetes Introduction/Purpose: Orthopedic physicians encounter many diabetes patients who receive anticoagulant treatment because vascular diseases are the chief causes of death and disability in these patients. In these patients, if surgery or other procedures are required, it is still unclear whether anticoagulation therapy administration should continue. After discontinuation of anticoagulation therapy, the risk of cardiovascular complications is increased, although complications of bleeding after surgery are decreased; this is a dilemma in the treatment of diabetic foot ulcer. The purpose of this study was to examine the effectiveness, safety, and hemostatic effect of kaolin-impregnated gauze on diabetic foot ulcer patients who continue to receive anticoagulants after surgical debridement. Methods: Twenty patients receiving anticoagulant medication with diabetic foot ulcers requiring surgical debridement were enrolled. Diabetic foot ulcers were treated using surgical debridement and a basic dressing protocol, which involved direct application of the dressing material to the wound bed. For the study group, a kaolin-impregnated dressing was used, and dry gauze was applied to patients in the control group. Patients were randomly assigned to either group, and we compared hemostatic efficacy and adverse effects between the two groups. The presence or absence of hemostasis was assessed 5 and 10 minutes after dressing application. Treatment was considered successful if bleeding ceased adequately and no extra hemostatic measures were required within 10 minutes. Results: In the 20 patients undergoing surgical debridement, there was no evidence of bleeding within 10 minutes of dressing application. Eight of the 10 patients treated with a kaolin-impregnated dressing achieved complete hemostasis within 5 minutes. Five of the 10 patients in the control group failed to achieve hemostasis within 10 minutes. No adverse effects were noted. Conclusion: The use of a kaolin-impregnated dressing appears to be a safe, feasible, and beneficial option for the management of diabetic foot ulcer patients with a high risk of bleeding.

scholarly journals Topically Applied Connective Tissue Growth Factor/CCN2 Improves Diabetic Preclinical Cutaneous Wound Healing: Potential Role for CTGF in Human Diabetic Foot Ulcer Healing

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
F. R. Henshaw ◽  
P. Boughton ◽  
L. Lo ◽  
S. V. McLennan ◽  
S. M. Twigg
Keyword(s):  
Wound Healing ◽  
Granulation Tissue ◽  
Ulcer Healing ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcer ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Fluid ◽  
Diabetic Wounds

Aims/Hypothesis. Topical application of CTGF/CCN2 to rodent diabetic and control wounds was examined. In parallel research, correlation of CTGF wound fluid levels with healing rate in human diabetic foot ulcers was undertaken.Methods. Full thickness cutaneous wounds in diabetic and nondiabetic control rats were treated topically with 1 μg rhCTGF or vehicle alone, on 2 consecutive days. Wound healing rate was observed on day 14 and wound sites were examined for breaking strength and granulation tissue. In the human study across 32 subjects, serial CTGF regulation was analyzed longitudinally in postdebridement diabetic wound fluid.Results. CTGF treated diabetic wounds had an accelerated closure rate compared with vehicle treated diabetic wounds. Healed skin withstood more strain before breaking in CTGF treated rat wounds. Granulation tissue from CTGF treatment in diabetic wounds showed collagen IV accumulation compared with nondiabetic animals. Woundα-smooth muscle actin was increased in CTGF treated diabetic wounds compared with untreated diabetic wounds, as was macrophage infiltration. Endogenous wound fluid CTGF protein rate of increase in human diabetic foot ulcers correlated positively with foot ulcer healing rate (r=0.406;P<0.001).Conclusions/Interpretation. These data collectively increasingly substantiate a functional role for CTGF in human diabetic foot ulcers.

scholarly journals Assessment role of phagocytic neutrophil cells among different Wagner’s grades of diabetic foot ulcers infections

2020 ◽  
Author(s):  
Eidha Ali Bin-Hameed ◽  
Maryam Hamed Baras
Keyword(s):  
Diabetes Mellitus ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Control Group ◽  
Diabetic Patients ◽  
Gram Negative Bacteria ◽  
Diabetic Foot Ulcers ◽  
Bacterial Isolates ◽  
Gram Negative

Abstract Background: Foot ulcers complications in diabetes mellitus (DM) patients are one of the significant medical problems and an economic burden. The aim of this study is to assessment role of phagocytic neutrophil cells and its relationship with the incidence of diabetic foot ulcers (DFU) infection of diabetic patients. A total of 60 venipuncture blood samples collected from diabetes mellitus, diabetic foot ulcer patients and healthy persons as control group. 20 swabs from the DFU patients were collected and processed for culture and susceptibility test after the ulcers classified according to Wagner’s grades system. Phagocytic cells activity test was performed to determine the efficiency of phagocytic neutrophil cells in diabetic patients. Results: Gram positive bacteria were the most prevalent in the DFU patients 57.1% with statistical significant relationship between the type of bacteria and grades of Wagner’s classification followed by Gram negative bacteria in high grades of ulcers. Wagner’s ulcers grade 1 and 2 were the most prevalence in DFU patients 30%. There was a weak negative correlation between the efficiency of phagocytic neutrophil cells activity and grade ulcers classified (r = -0.323). Amikacin and ciprofloxacin were the most effective antibiotics against 90.5% and 81% of the bacterial isolates respectively, whereas ampicillin, cefepime and cefadroxil were less effective antibiotics against the bacterial isolates.Conclusion: When the grade of ulcer increased, the bacterial resistance to antibiotics increased, and this was emphasis the correlation with prevalent of Gram negative bacteria in the high grade of ulcers with high resistance of antibiotics. In contrast, the grade of ulcer increased, the efficiency of phagocytic neutrophil cells decreased.

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