| 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
|
|
|
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
|
|
|
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 |