FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2015/01/005457 [Registered on: 23/01/2015] Trial Registered Retrospectively
Last Modified On: 22/01/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two different dressings, honey dressing and betadine dressing in patients with diabetic foot ulcer 
Scientific Title of Study   Clinico Microbiological efficacy of Honey Dressing in comparison with Povidone Iodine Dressing on Diabetic Foot Ulcers: a Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPrabha adhikari 
Designation  Professor  
Affiliation  Department of medicine, Kasturba Medical College, Mangalore, Manipal University 
Address  professor of medicine kasturba medical college hospital attavr Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880991290  
Fax    
Email  prabha.raghuveer@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrPrabha adhikari 
Designation  Professor  
Affiliation  Department Of Medicine, Kasturba Medical College, Mangalore, Manipal University 
Address  professor of medicine kasturba medical college hospital attavr Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880991290  
Fax    
Email  prabha.raghuveer@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPrabha adhikari 
Designation  Professor  
Affiliation  department of medicine, kasturba medical college, mangalore, manipal university 
Address  professor of medicine kasturba medical college hospital attavr Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880991290  
Fax    
Email  prabha.raghuveer@gmail.com  
 
Source of Monetary or Material Support  
MANIPAL UNIVERSITY Madhav Nagar Manipal - 576 119, udupi district, karnataka  
 
Primary Sponsor  
Name  Manipal university 
Address  Manipal University madhav nagar Manipal Karnatakai 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabha Adhikari  kasturba medical college hospital  Department Of Surgery Kasturba Medical College hospital attavar Mangalore
Dakshina Kannada
KARNATAKA 
9880991290

prabha.raghuveer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  DIABETIC FOOT ULCER PATIENTS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  honey dressing  honey dressing upto 6 weeks applied topically 
Comparator Agent  Povidone iodin  Povidone iodine dressing upto 6 week applied topically  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 )
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PERCENTAGE REDUCTION IN ULCER SIZE AFTER 6 WEEKS OF DRESSING  6week 
 
Secondary Outcome  
Outcome  TimePoints 
• Incidence of adverse events
• Proportion of participants with completely healed wound
• Proportion of participants with Microbiological clearance.
• Incidence of super infection
• Length of hospital stay
• Time of appearance of healthy granulated tissue
• Number of debridement required
• Effect on exudate and malador
 
baseline and then every week upto 6 week 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/12/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 

Diabetes is the 3rd leading cause of death. More than 285 million people worldwide have diabetes. WHO projected that diabetes death will double between 2005 & 2030. One of common cause of morbidity in ulcer patient is diabetic foot ulcer. There are several treatment options available for diabetic foot ulcer but with its own limitations.

Honey has been used to treat wound since ancient time. But medical evidence supporting this is limited. There are few case reports and also few randomized control trials which have shown effectiveness of honey in treating ulcer. most of reviews on honey has concluded that there is limitation in the quantity of data produced suggested to have more no of trials with honey for wound treatment. Honey has got multiple properties like antioxidant, anti-inflammatory, antimicrobial which may contribute to its wound healing property. Honey may stimulate multiple actions on wounds. It appears to draw fluid from the underlying circulation, providing both moist environment and topical nutrition which may enhance tissue growth. Therefore a randomized controlled trial is needed to establish the effect and role of honey on wound healing and infection clearance in patients with diabetic foot ulcers.

The following study is an Open label randomized controlled clinical trial with 2 arms-Betadine dressing group, honey dressing group. Each group will have 40 patients each. After Informed consent, eligible patients will be randomized to one of the treatment arms. A detailed medical history including diabetes history and its complications, vital signs and physical examination will be performed. Wound will be inspected. Wound stage, size, depth, presence of slough, exudates, malodor and status of the granulation tissue will be noted. Patients will be examined by surgical experts to exclude cellulites, abscess, osteomyelitis or gangrene. Fasting plasma glucose will be done before recruiting the patient.

At the baseline visit microbiological culture from the wound will be obtained. After collection of exudates for culture, treatment with honey or povidone iodine will be started, daily dressings will be done until the patient is discharged. After discharge the dressing frequency may be altered as per the decisions of surgeons. Patients will be examined for clinical response and infection clearance up to 3 weeks. Final examination will be done at 6 week from the commencement of the treatment.

This study is aimed at evaluating the clinical and microbiological efficacy of honey which may help in bringing topical honey preparation as the standard therapy for diabetic ulcer treatment in future

 
Close