A clinical trial to study the effects of two different dressings, honey dressing and betadine dressing in patients with diabetic foot ulcer
- Conditions
- Health Condition 1: null- DIABETIC FOOT ULCER PATIENTS
- Registration Number
- CTRI/2015/01/005457
- Lead Sponsor
- Manipal university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
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 )
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PERCENTAGE REDUCTION IN ULCER SIZE AFTER 6 WEEKS OF DRESSINGTimepoint: 6week
- Secondary Outcome Measures
Name Time Method â?¢Incidence of adverse events <br/ ><br>â?¢Proportion of participants with completely healed wound <br/ ><br>â?¢Proportion of participants with Microbiological clearance. <br/ ><br>â?¢Incidence of super infection <br/ ><br>â?¢Length of hospital stay <br/ ><br>â?¢Time of appearance of healthy granulated tissue <br/ ><br>â?¢Number of debridement required <br/ ><br>â?¢Effect on exudate and malador <br/ ><br>Timepoint: baseline and then every week upto 6 week