Evaluation of Hydrogel dressing in treatment of Diabetic foot Ulcer
Phase 3
Recruiting
- Conditions
- Chronic diabetic foot Ulcer.Type 2 diabetes mellitus with foot ulcerE11.621
- Registration Number
- IRCT20170612034485N1
- Lead Sponsor
- Iranian academic center for education culture and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1) Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner I & II
full informed consent for recruitment in random allocation
Exclusion Criteria
Suspected osteomyelitis
Evidence of severe Ischemia (ABI less than 0.8)
ESR more than 70
Using corticosteroid or immuno-suppressor drug
Chronic renal failure of Hemodialysis
Charco Joint
Suspected malignancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete wound healing during study (at least 6 months). Timepoint: every month up to Month 6th. Method of measurement: inspection.;Changes of wound area. Timepoint: week 1, 2, 3, 4, 6 month 3, 4, 6. Method of measurement: photography.
- Secondary Outcome Measures
Name Time Method IV Antibiotic therapy. Timepoint: every month up to month 6th. Method of measurement: clinical examination.