Clinico Microbiological efficacy of Honey Dressing in comparison with Povidone Iodine Dressing on Diabetic Foot Ulcers: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PERCENTAGE REDUCTION IN ULCER SIZE AFTER 6 WEEKS OF DRESSING
研究概览
简要总结
Diabetesis the 3rd leading cause of death. More than 285 million peopleworldwide have diabetes. WHO projected that diabetes death will double between2005 & 2030. One of common cause of morbidity in ulcer patient is diabeticfoot ulcer. There are several treatment options available for diabetic footulcer but with its own limitations.
Honey has been used to treat wound since ancienttime. But medical evidence supporting this is limited. There are few casereports and also few randomized control trials which have shown effectivenessof honey in treating ulcer. most of reviews on honey has concluded that thereis limitation in the quantity of data produced suggested to have more no oftrials with honey for wound treatment. Honey has got multiple properties likeantioxidant, anti-inflammatory, antimicrobial which may contribute to its woundhealing property. Honey may stimulate multiple actions on wounds. It appearsto draw fluid from the underlying circulation, providing both moist environmentand topical nutrition which may enhance tissue growth. Therefore a randomizedcontrolled trial is needed to establish the effect and role of honey on woundhealing and infection clearance in patients with diabetic foot ulcers.
Thefollowing study is an Open label randomized controlled clinical trial with 2arms-Betadine dressing group, honey dressing group. Each group will have 40patients each. After Informed consent, eligible patients will be randomized toone of the treatment arms. A detailed medical history including diabeteshistory and its complications, vital signs and physical examination will beperformed. Wound will be inspected. Wound stage, size, depth, presence ofslough, exudates, malodor and status of the granulation tissue will be noted. Patientswill be examined by surgical experts to exclude cellulites, abscess,osteomyelitis or gangrene. Fasting plasma glucose will be done beforerecruiting the patient.
Atthe baseline visit microbiological culture from the wound will be obtained.After collection of exudates for culture, treatment with honey or povidoneiodine will be started, daily dressings will be done until the patient isdischarged. After discharge the dressing frequency may be altered as per thedecisions of surgeons. Patients will be examined for clinical response andinfection clearance up to 3 weeks. Final examination will be done at 6 weekfrom the commencement of the treatment.
This study is aimed at evaluating theclinical and microbiological efficacy of honey which may help in bringingtopical honey preparation as the standard therapy for diabetic ulcer treatmentin future
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient voluntarily willing to participate and give written informed consent, to comply with all study requirements Patient with Known or newly diagnosed diabetes mellitus confirmed by ADA 2013 criteria Patients with non healing ulcer of Wagner Classification grade 1 and 2 for atleast 2 weeks Patients willing to follow up and complete treatment Patient who does not require frequent debridement.( frequent debridement is defined as >1 debridement a ulcer per week ).
排除标准
- •Acute wound less than 2 weeks duration.
- •Patients with ulcer (Wagner classification 3,4 and 5 Patient with cellulitis or abscess.
- •Fasting plasma glucose, more than 240mg/dl at the time of recruitment Renal disease needing hemodialysis or transplantation Hepatic disease with elevated transaminases > 2.5 times the upper limit of normal or bilirubin > 2 mg/dl congestive cardiac failure with NYHA class III and IV Patient with active MRSA, VRE, Streptococcal infection.
- •Patients on i.v antibiotics.
结局指标
主要结局
PERCENTAGE REDUCTION IN ULCER SIZE AFTER 6 WEEKS OF DRESSING
时间窗: 6week
次要结局
- •Incidence of adverse events(•Proportion of participants with completely healed wound)