Biofilm Study in Diabetic Foot Ulcer
Phase 1
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2021/10/037615
- Lead Sponsor
- GMERS Medical college Valsad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patient of type-2 DM
2.Patient having ulcer on foot for more than 4 weeks.
3.Patient who is ready to give consent & cooperative.
4. Patient should have palpable dorsalis pedis & post tibial artery.
5.Ulcers should be chronic i.e. of more than 4 weeks duration.
Exclusion Criteria
1.Patient not ready to give consent.
2.Irregular in taking medicine.
3.Persistently High Blood Sugar(FBS > 200mg% and/or PP2BS > 280 mg%).
4.Serum Creatinine > 3mg/dl
5.Poor Nutritional Status (Serum Protein >6.5 gm ,Serum Albumin < 3gm and or hemoglobin < 7 mg).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To know the rate of occurrence of biofilm in diabetic foot ulcer and to know the effectiveness of Cadexomer iodine and nano silver ointment in healing of chronic Diabetic foot ulcer with biofilm.Timepoint: Each patient will be dressed twice weekly & will be assessed for 6 weeks.
- Secondary Outcome Measures
Name Time Method To compare the effectiveness of Cadexomer Iodine & nano Silver ointment in treating biofilm.Timepoint: Wound will be assessed every week for clinical and microbiological assessment for 6 weeks.